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					                                             National Institute for Health and Clinical Excellence

                  Preventing Sexually transmitted Infections and Teenage conceptions Scope Stakeholder Consultation Table

                                                                   October 2005


    Stakeholder            Section                              Comments                                                   Response
                           number              Please insert each new comment in a new row.                     Please respond to each comment

Department of          General       Unintended” or “unwanted” under 18 conceptions would be                  The guidance title reflects the remit
Reproductive Health,                 preferable                                                               that was given to NICE by DH and
Lewisham PCT                                                                                                  refers to ‘reducing the rate of under
                                                                                                              eighteen conception’. There are
                                                                                                              difficulties defining the terms
                                                                                                              ‘unintended’ and ‘unwanted’, so we
                                                                                                              will use the more general one.
Department of          3             The increase in Chlamydia rates has coincided with the introduction      Agreed.
Reproductive Health,                 of more sensitive tests, and this needs to be made clear. If
Lewisham PCT                         screening is introduced rates will inevitably show an apparent rise
                                     before falling.
                                     There is no study that I know of that has looked at total population     Two population-based chlamydia
                                     rates of chlamydia (unlike HIV where unlinked anonymous testing          prevalence studies have been
                                     has been possible) and so the rate of undiagnosed chlamydia is not       published.
                                     known.
Department of          3             PID and cervical cancer are the consequences of STIs                     Agreed. We will clarify the scope.
Reproductive Health,
Lewisham PCT
Department of          4.2.3         The chlamydia screening programme is generally under 25s, not            Agreed. Scope amended.
Reproductive Health,                 excluding the under 16s. These very young people are especially
Lewisham PCT                         vulnerable and have very high rates of infection
Department of          4.4           Can the DH guidance on under 13s (and the involvement of police          ‘Working Together’ will be considered
Reproductive Health,                 or social services) be made explicit? There is great confusion over      when it becomes available.
Lewisham PCT                         this, and serious concerns that very young people will not attend
                                     services if they are not fully confidential, or will do so using false
                                     details
Department of          4.6           Negotiating skills and self-confidence are crucial here, without         Agreed. These are included in ‘skills

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    Stakeholder           Section                                   Comments                                                 Response
                          number                   Please insert each new comment in a new row.                   Please respond to each comment

Reproductive Health,                     them knowledge is useless                                              development’.
Lewisham PCT
Department of          4.8               Something is needed here about attracting the right people to this     This may arise when we consider the
Reproductive Health,                     work, in particular paying them adequately.                            role of the intervener within the
Lewisham PCT                                                                                                    research questions.
Deafax                 Section 3 –       We are aware that there is no mention of disabled people especially    We agree that it is important to be
                       Appendix A        young deaf people, in your scope. Research has shown that              inclusive of people with disabilities.
                                         services currently available in the area of sexual health education,   Interventions which target people with
                       Inequalities in   teenage pregnancy issues and support systems focus only upon           disabilities will not be excluded from
                       sexual health     HEARING young people. Services currently provided, focus               the literature searches.
                                         predominantly upon mothers, with little aimed at fathers. NO
                                         SERVICES are currently provided or exist to our knowledge that are
                                         culturally and linguistically equipped to adequately and
                                         appropriately support young DEAF and HARD OF HEARING
                                         people. A simply internet search reveals that there are no contacts
                                         or specific services provided for this group – almost all young deaf
                                         people rely heavily upon the internet as their source of information
                                         and guidance.

                                         There is also substantial research evidence of incidences where
                                         deaf people have found the process of pregnancy, birth and
                                         parenthood both upsetting and humiliating. Incidences where
                                         individuals have been either misinformed or not informed at all,
                                         where communication support has not been made available,
                                         removing their control and decision making rights and leaving them
                                         feeling distressed and confused about what was happening.

                                         Younger people have demonstrated naivety and ignorance having
                                         never received appropriate education and information regarding
                                         sexual reproductive, in their first language BSL (British Sign
                                         Language), leaving them often grossly misinformed and misguided
                                         about the consequences of their actions. Furthermore, at
                                         heightened risk of placing themselves in unsafe situations where


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    Stakeholder      Section                                   Comments                                                      Response
                     number                   Please insert each new comment in a new row.                        Please respond to each comment

                                   they are vulnerable.

                                   The following comments and questions arose form a discussion that
                                   took place September 2004 within a deaf youth group from Norwich
                                   ages 14-22:-

                                   “I didn’t know what contraception was”; “Can I get pregnant from
                                   kissing?”; “I am at risk if I socialise with gay people”; “It’s ok to have
                                   unprotected sex when you have a period”; “I don’t need to worry
                                   about using a condom”. During this discussion over half of the
                                   young people had never heard of ‘the pill’ or knew what a condom
                                   looked like. Those that had thought that the morning after pill could
                                   be taken regularly as a form of preventing pregnancy.

                                   Deafax is currently working upon a programme that aims to impact
                                   Deaf people and communities in 2 ways:

                                   To offer an inclusive and proactive PREVENTATIVE tool to
                                   educate, inform and empower young people to be able to make
                                   responsible and informed decisions about their sexual and
                                   reproductive choices. To offer an inclusive and proactive SUPPORT
                                   system in partnership with primary care service providers to
                                   educate, support and enable young parents and parents to be, to
                                   cope and deal with the progression of pregnancy, birth and
                                   subsequent challenges of change and parenthood in order to move
                                   forward with their lives. For more information see our website
                                   www.deafax.org

Deafax            Section 4.3      While Deafax supports one to one initiatives there are enormous              While we agree that groupwork can
                  Interventions    benefits to Deaf young people from participating in group based              be very important, NICE have decided
                  which will not   workshops and interventions not simply from the educational                  to prioritise one-to-one interventions in
                  be included:     standpoint but from the positive effect of role models, integration &        this particular guidance. There is the
                  1. Group         interaction, discussion and removal of taboos and ignorance. We              facility on the NICE website to
                  based            feel very strongly that in order to service communities effectively          suggest future projects should you

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    Stakeholder        Section                                 Comments                                                    Response
                       number                 Please insert each new comment in a new row.                      Please respond to each comment

                    interventions   and appropriately that groupwork be included in your scope.               wish to suggest this, at:
                    including sex                                                                             www.nice.org.uk/page.aspx?o=topics
                    and                                                                                       uggest. We would expect that at some
                    relationship                                                                              time in the future NICE will be asked
                    education.                                                                                to consider these broader issues.
Royal College of    General         The RCOG is concerned about both of the issues to be addressed            Thank you.
Obstetricians and                   in this guidance (rising STI rates and unintended teenage
Gynaecologists                      pregnancies) and welcomes the development of formal guidance in
                                    this area.
Royal College of    4.1             There was much discussion about the scope of “one to one”                 Agreed. Postal screening will be
Obstetricians and                   interventions at the Stakeholders Meeting. We wonder whether this         included and will be added to the
Gynaecologists                      would include postal screening by a practitioner. This has been tried     scope.
                                    with some success in the UK1 and with more success in Europe.2 It
                                    is clearly not a face to face intervention, but might be a “one to one”
                                    intervention if the invitation to home screen comes from the
                                    patient’s GP.
Royal College of    4.2             Under interventions, the contraceptive advice/provision includes          It was not the intention to exclude
Obstetricians and                   Emergency hormonal contraception. Is the exclusion of emergency           IUD. We will clarify this in the scope.
Gynaecologists                      non-hormonal contraception (e.g. the insertion of an IUCD as a post
                                    coital contraceptive) deliberate?
Royal College of    4.6             Outcome measures: The outcome defined in the draft scope is               Thank you for this helpful clarification
Obstetricians and                   Reduction in the rate of STIs. Does this mean reduction in                which will inform the work of the
Gynaecologists                      prevalence of STIs, or reduction in the number of STIs reported? It       Public Health Interventions Advisory
                                    would be worth clarifying exactly which outcome measure is to be          Group (PHIAC). However, we will be
                                    used. We feel the guidance should cover both the prevalence and           constrained in our research searches
                                    incidence of infection of STIs in the UK. Prevalence and incidence        by the outcome measures used in the
                                    of infection is only loosely related to the number of STIs reported       primary research reviewed.
                                    (the outcome presented at the Stakeholders Meeting). The number
                                    of STIs reported is heavily influenced by the extent of screening and
                                    the availability of both effective tests and services. These may
                                    change in the time period covered by the guidance, and thus
                                    changes in numbers STIs reported may not reflect changes in
                                    prevalence and incidence of infection. Thus the choice of number of

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    Stakeholder     Section                              Comments                                                   Response
                    number              Please insert each new comment in a new row.                     Please respond to each comment

                              STIs reported may not accurately detail how effective the guidance
                              is in reducing the incidence/prevalence of infection. This is
                              particularly important with infections like Chlamydia, which are often
                              asymptomatic. Attention is drawn to the NATSAL survey of                 Noted.
                              prevalence of infection.3
Brook             General     Brook welcomes the opportunity to comment on this scope. We              Thank you. We recognise the range of
                              note that NICE has decided to concentrate on one-to-one                  interventions which could be
                              interventions on this occasion. Given evidence to show that              considered, but due to time and
                              combining effective sex and relationships education with access to       resource constraints NICE has
                              confidential services is instrumental in delaying first sex and          decided to focus this guidance on
                              encouraging contraceptive use we would hope for future guidance          one-to-one interventions. There is the
                              to provide a similar assessment of group based interventions.            facility on the NICE website to
                                                                                                       suggest topics for consideration for
                                                                                                       our future guidance. Visit:
                                                                                                       www.nice.org.uk/page.aspx?o=topics
                                                                                                       uggest We would expect that at some
                                                                                                       point in the future NICE will be asked
                                                                                                       to look at these issues.
Brook             4.2   1.    It would be valuable to include help lines and provision of one to       Agreed. These will be added to the
                              one information via email or online enquiry services in the specific     scope.
                              interventions to be considered by the guidance. Substantial
                              numbers of young people get information and advice in this way.
                              Data from Brook’s Young People’s Information Service suggest that
                              the anonymity and confidentiality of this type of communication is
                              particularly attractive to young men and younger age groups in
                              general. The provision of confidential email and web-based
                              services to young people feature in both the Choosi The provision
                              of emergency contraception presents a key opportunity to provide
                              advice about prevention of conception and STIs in addition to the
                              examples given.ng Health white paper and Youth Matters green
                              paper
Brook             4.2         We welcome the fact that the guidance will include evidence of           Noted.
                              effectiveness as perceived by service users. In particular we hope

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    Stakeholder      Section                               Comments                                                     Response
                     number               Please insert each new comment in a new row.                       Please respond to each comment

                               that this will include exploration of the features of the service which
                               contribute to the user’s perceptions of its effectiveness.
Croydon PCT       4.2.1        We feel provision of emergency intrauterine contraception is also           Agreed. This will be clarified in the
                               and important intervention at which 1:1 health promotion is given.          scope.
                               There are many sites and service providers who do not offer this
                               method, and it is also important that at the point of referral there is
                               input to address the issues of STI and future avoidance of potential
                               unplanned pregnancy.
Croydon PCT       4.2.3 and    Evidence around 1:1 input by school nurses if taken in isolation            We recognise the range of
                  ‘general’    from SRE and the environment/discussion opportunities from the              interventions which could be
                               education side of the young person’s life will be difficult to interpret.   considered, but due to time and
                               Tensions between what is permitted in schools from the education            resource constraints, NICE has
                               side and what is provided by health workers is an area that                 decided to focus this guidance on
                               deserves closer scrutiny.                                                   one-to-one interventions. There is the
                               Peer education/advice in group settings should also be included.            facility on the NICE website to
                                                                                                           suggest topics for consideration for
                                                                                                           our future guidance at:
                                                                                                           www.nice.org.uk/page.aspx?o=topics
                                                                                                           uggest We would expect that at some
                                                                                                           point in the future NICE will be asked
                                                                                                           to look at these issues.
Croydon PCT       4.3          As indicated in 4.2.3                                                       As above.
Croydon PCT       4.7          If target audience is to include head teachers, teachers and                The primary audience for this
                               lecturers, would be more helpful to have outcomes of their own              guidance is the NHS; however it will
                               opportunities for interventions in classroom settings.                      be relevant to a wide range of
                                                                                                           professionals and others.
Croydon PCT       4.2          Need to evaluate interventions targeting specific vulnerable groups         We agree that it is important to be
                               of young people including the disabled.                                     inclusive of people with disabilities.
                               Need to evaluate interventions targeting young men and BME                  Interventions which target people with
                               communities.                                                                disabilities will not be excluded from
                                                                                                           the literature searches. Both young
                                                                                                           men and BME communities are
                                                                                                           highlighted as populations of interest

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    Stakeholder             Section                                 Comments                                                    Response
                            number                 Please insert each new comment in a new row.                      Please respond to each comment

                                                                                                                   in section 4.4 of the draft scope.
Croydon PCT              4.8             Needs to evaluate interventions considering the                           We recognise that both training and
                                         training/background of professionals involved in 1 to 1 work-linking      kitemarking are important, but they
                                         to Government’s Workforce Reform Strategy-childrens’ workforce,           are outside of the remit of this scope
                                         around the development of the common core, which will be the              which focuses on one-to-one
                                         basis to assess competencies of practitioners in a wide range of          interventions.
                                         contexts including providing advice on teenage pregnancy and
                                         sexual health issues.
                                         Need some assessment of young peoples’ primary, and secondary             It is anticipated that confidentiality will
                                         reason for 1 to 1 intervention. Confidentiality issues need to be         arise as part of the literature
                                         included. Needs evaluation of badging/kitemarking of accredited           searches.
                                         young people friendly services

Association of Medical   General; 4.2;   Need to emphasise importance of effective communication between           We will not be considering diagnostic
Microbiologists (AMM)    4.8             providers of on-to-one interventions and local providers of               testing or treatment within this
                                         diagnostic services. Different tests are available which may be more      guidance. We would expect that at
                                         appropriate in certain environments. Need to determine what tests         some point in the future NICE will be
                                         are provided, for which infections, in which settings. It is important    asked to look at these issues.
                                         to consider non-traditional healthcare settings (youth clubs,
                                         pharmacies etc). In most situations samples will be locally collected
                                         and transported to laboratory for testing. In some settings, near-
                                         patient testing may be considered desirable, but any such initiatives
                                         require close collaboration with local microbiologists to ensure
                                         quality assurance.
Association of Medical   4.3             Agree with other professional bodies (RCP etc) that HIV should be         Agreed. Scope amended to include
Microbiologists (AMM)                    specifically included within scope, as this is where greatest potential   HIV.
                                         for cost-effective intervention
Association of Medical   4.8             Need to consider how requesters communicate results back to               We anticipate considering innovative
Microbiologists (AMM)                    patient. Innovative means of communication (eg texting) may be            means of communication within one-
                                         suitable for negative results for some client groups; some                to-one interventions.
                                         experience regarding this has been gained in pilot Chlamydia
                                         screening sites. Positive results will require further face-to-face
                                         follow-up.

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    Stakeholder             Section                              Comments                                                    Response
                            number              Please insert each new comment in a new row.                      Please respond to each comment

Association of Medical   4.8          Need to consider how treatment, if required, is delivered following       This guidance will not consider
Microbiologists (AMM)                 one-to-one interventions. Effective arrangements for follow-up            treatment, although at some point
                                      enable treatment to be offered once results are known, but if follow-     NICE may be requested to do so.
                                      up compliance is thought unlikely, empirical treatment or fast-track      There is the facility on the NICE
                                      testing may be considered. This may be provided through a local           website to suggest topics for
                                      provider, or on-site near patient testing may be desirable (see also      consideration for our future guidance
                                      above regarding quality assurance). Such initiatives have resource        at:
                                      implications.                                                             www.nice.org.uk/page.aspx?o=topics
                                                                                                                uggest
Association of Medical   4.9.2        Lack of local funding in some areas has led to inequity of availability   Noted.
Microbiologists (AMM)                 of certain diagnostic tests, particularly Chlamydia nucleic acid
                                      amplification (NAAT) tests. The focus of testing is likely to be on
                                      non-invasive or self-taken samples (urines and vulvo-vaginal
                                      swabs), and all such samples should be tested using optimal
                                      methodology. NAATs are also potentially able to detect gonococcal
                                      infection in addition to Chlamydia (using the same sample); this is
                                      an opportunity for screening to provide valuable epidemiological
                                      information regarding gonorrhoea as well as chlamydia.
Association of Medical   General      Effective funding streams need to be established to support the           Noted.
Microbiologists (AMM)                 required infra-structure for the initiative. Agreement for such funding
                                      will depend on prioritisation by PCTs and/or other commissioning
                                      bodies
Medical Foundation       General      The development of evidence based guidance on sexual health               Thank you. We agree that there are
for AIDS & Sexual                     interventions is welcome. However, we hope there will soon be a           many factors which influence sexual
Health (MedFASH)                      further NICE initiative to develop programme guidance.                    health and a range of interventions for
                                      Sexual health attitudes and therefore behaviour are much                  prevention of poor sexual health. We
                                      influenced by the social climate, peer norms and stigma, and the          recognise the range of interventions
                                      broader determinants of sexual ill-health include economic                which could be considered, but due to
                                      deprivation and social marginalisation. These factors cannot readily      time and resource constraints, NICE
                                      be addressed by single interventions in isolation, nor is it easy to      has decided to focus this guidance on
                                      see how the impact on such variables of single interventions within       one- to-one interventions. There is the
                                      a programme could be measured to assess effectiveness. A                  facility on the NICE website to
                                      comprehensive programme of sexual health promotion is needed              suggest topics for consideration for

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    Stakeholder          Section                               Comments                                                    Response
                         number               Please insert each new comment in a new row.                      Please respond to each comment

                                   and will be more likely to have a measurable impact.                       our future guidance at:
                                   The recently published and Dept of Health endorsed                         www.nice.org.uk/page.aspx?o=topics
                                   Recommended standards for sexual health services (MedFASH,                 uggest We would expect that at some
                                   2005) recommended such a programme and included as its first               point in the future NICE will be asked
                                   two ‘key interventions’ for promoting sexual health (Standard 2),          to look at these issues.
                                   backed by level 1 and 2 evidence:
                                    - "Programmes and interventions which are multi-component are
                                   most effective in reducing sexual ill health." (I think this is from the
                                   HDA STI prevention effectiveness review)
                                   - "Programmes that focus on strengthening perceived norms that
                                   promote safer sex can lead to reduced sexual risk-taking (for
                                   example, through use of peers or popular opinion leaders)."

                                   In addition, faced with the new challenge of meeting Choosing
                                   Health sexual health targets in the context of NHS financial
                                   pressures and competing priorities, local commissioners will benefit
                                   greatly from guidance which helps them determine what would be
                                   most effective and cost effective to commission. In this context, it
                                   may not seem the right priority for a high profile and highly
                                   resourced national body like NICE to be examining, for example,
                                   the finer detail of whether provider referral is more effective than
                                   patient referral (as partner notification), rather than taking a broader
                                   brush look at what are the elements of an effective and cost-
                                   effective sexual health programme overall and what are their
                                   respective contributions to reducing transmission of STIs and
                                   unintended pregnancies.
Medical Foundation   2             It is stated that the guidance will focus on ‘one to one or face to face   See above answer to ‘General’.
for AIDS & Sexual                  interactive’ interventions. Following on from our comment above,
Health (MedFASH)                   and for the same reasons, this seems a further regrettable
                                   limitation. According to the paper setting out the NICE Operating
                                   model for the CPHE, ‘interventions’ may be population, community
                                   or individually based. At the least, it would be desirable for the
                                   evidence review and guidance to offer the opportunity to compare


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    Stakeholder          Section                               Comments                                                    Response
                         number               Please insert each new comment in a new row.                      Please respond to each comment

                                   non-one-to-one interventions such as peer-led group work with
                                   other interventions which are one-to-one.
Medical Foundation   3             A minor point about accuracy: after the table, there seem to be            We will check these data.
for AIDS & Sexual                  conflicting figures for total new STI diagnoses in 2004: 696,419 and
Health (MedFASH)                   751,282. Could this be England vs. UK? Or people vs. diagnoses
                                   (as one person may have 2 or 3 STI diagnoses)?
Medical Foundation   General       There seems to be some confusion about objectives in the                   Agreed. The scope will be amended
for AIDS & Sexual                  document. Is the intention to reduce 'teenage' conceptions or              accordingly.
Health (MedFASH)                   'unintended' conceptions (or 'unintended teenage')? Is teenage
                                   pregnancy undesirable per se? There's virtually nothing in the
                                   earlier sections of the document to argue that it is - in fact the
                                   opposite is argued. However, the national target and DH remit for
                                   the guidance are about reducing the rate of under 18 conceptions
                                   (no mention of unintended). It can help to avoid the term
                                   'preventing' teenage conceptions/pregnancy (because they are not
                                   always bad) in favour of 'reducing the rate of', which could of course
                                   encompass 'prevention' of 'unintended'. The scope document does
                                   this in places, but not everywhere. It will be important to be
                                   absolutely clear about the objectives before starting an exercise to
                                   assess effectiveness and produce guidance.
Medical Foundation   3             Bullet 2 in ‘Inequalities in sexual health’ – a point of accuracy. The     Noted. We will amend for accuracy.
for AIDS & Sexual                  phrase ‘70% of HIV infected heterosexual patients seen for care” is
Health (MedFASH)                   surely not correct for two reasons. Firstly, the statistics collected by
                                   the HPA record details of the route of transmission (i.e. in this case,
                                   infection believed to be acquired through sex between men and
                                   women) not the sexual orientation (i.e. heterosexual) of the
                                   individuals infected. Aside from being inaccurate, it is hard to see,
                                   in the context of the point being made here (BME populations being
                                   disproportionately affected), why it is actually relevant to specify
                                   sexuality at all.
                                   Secondly, the records of ‘HIV infected. Patients seen for care’
                                   would be the HPA’s SOPHID data. These do not show 70% of
                                   people currently receiving care for HIV to be black African – the

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    Stakeholder          Section                              Comments                                                   Response
                         number              Please insert each new comment in a new row.                     Please respond to each comment

                                   proportion is still under half (see
                                   http://www.hpa.org.uk/infections/topics_az/hiv_and_sti/hiv/epidemio
                                   logy/files/2004_SHA_Web_tables.pdf). However, 70% does look
                                   like a recent figure for the annual number of new HIV diagnoses. It
                                   is very important to distinguish, when assessing needs and
                                   monitoring trends, between the total numbers and characteristics of
                                   those living with diagnosed HIV and of those newly becoming a part
                                   of this cohort each year.
Medical Foundation   3             ‘Trends’. NATSAL surely also shows an increased rate of condom           Noted.
for AIDS & Sexual                  use among young people (somewhat offsetting the other factors of
Health (MedFASH)                   increasing risk quoted here). As condom use is a key means of
                                   reducing STIs and unintended pregnancy, perhaps the NATSAL
                                   findings should be carefully looked at.
Medical Foundation   4.1           Para 2 i) refers to reducing ‘incidence’. Is this the same as            We will clarify these terms in the
for AIDS & Sexual                  ‘transmission’ (as in the DH remit)? Ii) Refers to ‘teenage’             scope.
Health (MedFASH)                   conceptions. Is this the same as ‘under 18’ conceptions (as in the
                                   DH remit)?
Medical Foundation   4.2           Para 1. An additional characteristic of effective interventions (Ellis   Noted.
for AIDS & Sexual                  & Grey, 2004) is being multi-component and multi-level. These
Health (MedFASH)                   characteristics are presumably also not present in one-to-one
                                   interventions (as mentioned in Para 2). See above, for comments
                                   re limitations of addressing only one-to-one interventions. Also,
                                   Para 2 seems confusing, as it appears to be suggesting that NICE
                                   wants to prioritise looking at interventions that don't have the
                                   characteristics of effectiveness, i.e. that are presumably not
                                   effective. Misleading?
Medical Foundation   4.2 and       Although mentioned in the statistical appendix about STIs, sexuality     We will clarify the inclusion of young
for AIDS & Sexual    general       is almost invisible in the main document (eg 4.8.8 mentions only         men who have sex with men (MSM) in
Health (MedFASH)                   age, gender, class, ethnicity). Also, by bringing together in one        the scope. The focus on STI
                                   'specific intervention' (4.2, point 1) prevention of both under 18       prevention and HIV prevention will not
                                   conceptions and STIs, there is a risk that the STI prevention focus      be on under-18’s, but on all age
                                   will be on heterosexual under 18s, paying inadequate attention to        groups.
                                   other groups at higher risk, especially gay men. Even in relation to

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    Stakeholder         Section                               Comments                                                    Response
                        number               Please insert each new comment in a new row.                      Please respond to each comment

                                  young people, there is no reference to young gay men who should
                                  be a key target for condom provision, for example.
Medical Foundation   4.2.2        There has recently been much attention to, and concern among               Noted.
for AIDS & Sexual                 professionals and patient groups about, criminal prosecutions for
Health (MedFASH)                  HIV transmission. What are the implications for healthcare
                                  professionals in relation to disclosure? This could be a very useful
                                  and interesting aspect of the guidance, but will probably need to
                                  keep constantly up to date with the rapidly moving legal
                                  developments.
Medical Foundation   4.2.3        How can 'screening' be assessed for effectiveness in reducing              Thank you for these points of which
for AIDS & Sexual                 chlamydia transmission in the limited way proposed? Screening              we are aware. Effectiveness needs to
Health (MedFASH)                  can identify those who are infected, but a number of links in the          include reduction of transmission and
                                  chain are needed to impact on transmission. Some very crucial              sequelae as well as issues to do with
                                  ones appear to be omitted from the NICE scope, begging a lot of            uptake of screening and partner
                                  questions about the selection of intermediate indicators and               notification etc.
                                  whether 'effectiveness' in terms of health outcomes can be inferred
                                  from them. Crucial among these are the accuracy of the tests used          It is not within the NICE remit to
                                  (see Health Select Committee report on sexual health 2003 for              consider the efficacy of the screening
                                  slamming criticism re types of test in use with very high rate of false    tests.
                                  negatives, since addressed by DH funding for screening
                                  programme, but delivery has been patchy).
                                   Another is the appropriateness of the treatment given. There are
                                  also big questions about how to ensure the partner is treated, to          This is an important point of relevance
                                  prevent re-infection - not only the partner notification options, but      when making recommendations.
                                  also whether it is possible and more effective to give the patient         Partner notification will be considered
                                  antibiotics to give to her/his partner (technically illegal). How about    within this scope.
                                  questions regarding whether it is more effective to treat at the site of
                                  testing or after referral to GUM?

                                  It seems strange in a way to select chlamydia screening when it has
                                  already received so much attention in relation to evaluation - i.e.
                                   the original CMO expert report, assessment by national screening
                                  cttee, pilot screening programme, roll-out with elements of                The title of the scope reflects the


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    Stakeholder        Section                                Comments                                                   Response
                       number                Please insert each new comment in a new row.                     Please respond to each comment

                                   evaluation (eg recently announced Boots contract which I believe         referral from the Department of Health
                                   includes evaluation). On the other hand, this could make it really       to NICE. This included chlamydia
                                   important to get past the excitement about innovative ideas and          screening. The review of chlamydia
                                   focus on identifying the real evidence for effectiveness and cost-       screening will certainly focus on the
                                   effectiveness of different approaches. Selection of indicators will be   ’real evidence for effectiveness and
                                   vital - eg how can you assess the differential impact on chlamydia       cost-effectivesness’ rather than
                                   transmission of screening in different settings (which may, for          respond to hype or excitement. The
                                   example, have very different characteristics such as                     choice of indicators used will depend
                                   space/time/skills for a confidential chat or not)?                       to a large extent on the literature that
                                                                                                            is reviewed. We are clearly only able
                                   Overall, guidance on STI screening (for Chlamydia or other               to report on the indicators used in the
                                   infections) seems to provide an ideal opportunity for the joining up     studies.
                                   of NICE’s role in relation to public health and treatment (see
                                   Operating model for the CPHE, para 4.4). However, on the                 NICE is developing integrated ways of
                                   evidence of this ‘scope’ document, the barriers remain firmly and        working between the preventative and
                                   regrettably drawn within NICE between the different but closely          treatment elements of its remit. This
                                   related areas of prevention and treatment – both of which impact, of     scope reflects the remit from
                                   course, on public health.                                                Ministers, not the internal structure of
                                                                                                            NICE.


Medical Foundation   4.2 and 4.3   HIV is very little mentioned in the draft ‘scope’, despite it being      The scope will be amended to include
for AIDS & Sexual                  arguably the greatest threat to public health and the biggest drain      HIV more clearly.
Health (MedFASH)                   on the public purse within the sexual health field. Death and ill-
                                   health resulting from HIV are not even mentioned in the
                                   consequences of poor sexual health. There is no mention of
                                   working with HIV-positive people to prevent transmission. This
                                   omission needs to be rectified and the assurances of NICE staff at
                                   the 23 September stakeholder meeting that it will be were very
                                   welcome.
Medical Foundation   4.2 and 4.3   GUM 'sexual health screens' and of 'screening for HIV, syphilis and      Other than chlamydia, screening and
for AIDS & Sexual                  hep B' are explicitly excluded. Clarity is needed regarding              testing will be excluded, although the
Health (MedFASH)                   wording... is the reference to 'screening' or 'testing'? Chlamydia       one–to-one prevention interventions


                                                                      13
    Stakeholder        Section                              Comments                                                    Response
                       number              Please insert each new comment in a new row.                      Please respond to each comment

                                 screening (which is to be covered in the scope, outside GUM) is           which are delivered alongside
                                 taken to be ‘opportunistic’ screening. What about the 'routine offer'     screening/testing, will be included.
                                 of testing, eg of an HIV test at first GUM visit? What about when a
                                 patient attends to request testing? Or when a doctor suggests a
                                 syphilis test in view of risk factors identified? The professionals are
                                 not always that clear either about wording, but NICE needs to be.

                                 It would appear that the diagnosis and treatment of symptomatic           Agreed, but this is outside the remit of
                                 STIs are also excluded. Effectively dealing with those who have           this scope.
                                 symptomatic STIs is at the core of prevention of STI transmission.
                                  Only those infected can transmit, and many infections are quickly
                                 curable, eliminating the risk of transmission by that individual.

                                 Questions about the relative effectiveness and cost-effectiveness of      We recognise the range of
                                 diagnosis and treatment in different settings, by different               interventions which could be
                                 professionals, within different time-spans, etc, could potentially be     considered, but due to time and
                                 extremely valuable. Partner notification (included in the NICE            resource constraints NICE has
                                 scope) is part of this but many other aspects are also important,         decided to focus this guidance on
                                 and it is regrettable that NICE is choosing to exclude them. (The         one-to-one interventions. There is the
                                 purely clinical aspects of treatment may be less important to             facility on the NICE website to
                                 address, because already the subject of clinical effectiveness            suggest topics for consideration for
                                 guidelines from BASHH).                                                   our future guidance at:
                                                                                                           www.nice.org.uk/page.aspx?o=topics
                                                                                                           uggest We would expect that at some
                                                                                                           point in the future NICE will be asked
                                                                                                           to look at these issues.
Medical Foundation   4.2         Evidence, as suggested, and guidance for provision in different           Noted. Thank you.
for AIDS & Sexual                settings, including schools, would be very helpful.
Health (MedFASH)
Medical Foundation   4.6         Para 4. As a primary outcome measure, what exactly is the 'rate' of       The outcome measures used will be
for AIDS & Sexual                STIs? Normally, surely, 'rate' implies prevalence or incidence as a       those found in the literature reviewed
Health (MedFASH)                 % of population. How will this be measured for STIs and is that the       for this guidance.
                                 intention. There are limited studies using this kind of measure


                                                                     14
    Stakeholder           Section                              Comments                                                    Response
                          number              Please insert each new comment in a new row.                      Please respond to each comment

                                    (except national HIV prevalence estimates based on anonymous
                                    screening programme) and at a population level, the best readily
                                    available statistics on STIs are numbers of new diagnoses (in
                                    GUM).

                                    Care is always needed when interpreting the meaning of rises or           Noted.
                                    falls in new diagnoses. They can be a measure of success in
                                    encouraging testing as much as of real incidence of infection. The
                                    term 'incidence' (also used in the scope document, apparently as a
                                    synonym for 'transmission') is sometimes used as shorthand for
                                    number of diagnoses, but clearly this is not the same as actual new
                                    infections. NB There are many undiagnosed STIs, so the task of
                                    assessing 'rates' of prevalence or incidence is much harder than for
                                    conceptions, which almost all eventually end in a baby or an
                                    abortion, both recorded in the official statistics.
                                    Also, until a new common sexual health dataset is finally
                                    introduced, the only nationally available STI data come from GUM
                                    clinics. There is surely no reliable source of statistics for chlamydia
                                    diagnoses in general practice, let alone pharmacy, unless special
                                    arrangements have been made as part of NCSP roll-out.
Medical Foundation     4.9.2        How does the approach used 'to account for the complexity and             See above response to 4.2 and 4.3.
for AIDS & Sexual                   multidimensional character of public health interventions' square
Health (MedFASH)                    with the intention to focus on specific 1-to-1 interventions in this
                                    NICE guidance?
Health Protection      General      A clear methodology is needed to review the evidence. Much of the         NICE has consulted on its operating
Agency--LARS                        published literature is written by people with great enthusiasm for       model. Specific methods and
                                    their own interventions, and little examination of the “confounding”      procedures for reviewing the evidence
                                    variables that may have led to change. This is particularly important     will be provided in detail in the
                                    in sexual health as so many variables, and combinations of                forthcoming methods and procedures
                                    variables, can lead to change. A further difficulty is that of applying   manuals, due to be published in
                                    results from one population to another, and of that of trying to          November.
                                    measure impact on a sub-population at total population level.
Brighton & Hove City   4.1          The emphasis in this review is on delivery of one to one direct           We will consider a range of settings,

                                                                        15
      Stakeholder         Section                                 Comments                                                  Response
                          number                 Please insert each new comment in a new row.                    Please respond to each comment

PCT                                    sexual health interventions. However, this mainly targets those         both those where people access
                                       accessing services. In GUM people who receive negative results          services and those based on outreach
                                       will be given advice on staying negative [though this as a strategy     models.
                                       for keeping those negative needs strengthening]. However in opt-
                                       out services such as through ANC only those found to be positive
                                       for HIV, hepatitis B or syphilis will be given thorough advice,
                                       missing an opportunity for advising those at risk such as African
                                       origin women, how to stay negative. This missed opportunity needs
                                       evaluation.
Brighton & Hove City   4.3             In addition, late presentation for diagnosis is a concern for African   We agree that there are many factors
PCT                                    origin people. Stigma is a major barrier for individuals’ self          that influence sexual health and a
                                       identifying as being at risk. One of the ways of addressing this and    range of interventions for the
                                       awareness of risk of HIV and STIs in these communities is through       prevention of poor sexual health. We
                                       community education, for instance through faith based                   recognise the range of interventions
                                       organisations. This does not fit into the one-to-one health             which could be considered, but due to
                                       professional model. If it is not included in this review the            time and resource constraints, NICE
                                       opportunity for addressing this problem for heterosexual                has decided to focus this guidance on
                                       transmission among new migrants with urgency will be lost.              one-to-one interventions. There is the
                                                                                                               facility on the NICE website to
                                                                                                               suggest topics for consideration for
                                                                                                               our future guidance at:
                                                                                                               www.nice.org.uk/page.aspx?o=topics
                                                                                                               uggest We would expect that at some
                                                                                                               point in the future NICE will be asked
                                                                                                               to look at these issues.
Brighton & Hove City   4.2             Much of the literature on what works with communities within local      NICE literature searches include world
PCT                    Interventions   African contexts would be relevant to African people living here,       literature.
                                       especially new migrants, who represent a microcosm of the society
                                       they have come from rather than where they are living now. The
                                       literature review on ANC, VCT, stigma, economic evaluation etc
                                       needs therefore to include world literature pertinent to African
                                       societies.
Brighton & Hove City   4.8 research    Research questions that emerge from the evidence should also be         The guidance will include

                                                                          16
      Stakeholder         Section                              Comments                                                   Response
                          number              Please insert each new comment in a new row.                     Please respond to each comment

PCT                     questions   considered.                                                              recommendations for future research.

Brighton & Hove City    General     Grey literature publications should also be considered. How to           Grey literature is included in the list of
PCT                                 integrate education given in the various vertical strands of sexual      evidence which NICE will consider.
                                    health programmes would be an important component of improving
                                    services.
Nottingham University   General     The basis for restricting the scope to one-to-one interventions is not   We will make the focus explicit in the
Business School                     clear. There seems to be no such specific direction in the Brief         final edition of the scope.
                                    from Ministers and this was clearly causing some confusion at the
                                    Stakeholder Meeting in London. If the Brief was not intended to
                                    restrict the guidance to one-to-one interventions, then thought
                                    should be given to revising the scope to take account of this. If the
                                    restriction is maintained, then its rationale should be made explicit.
Nottingham University   4.2         Specific Intervention number 1 is framed very tightly. It gives the      Delay of sexual activity and reduction
Business School                     impression that that contraceptive advice and provision is the only      of partners will be included as
                                    intervention aimed at reducing teenage pregnancy. Although               interventions to be considered to
                                    alternatives are hinted at in bullet point 3, it should be made more     reduce under 18 conceptions and
                                    explicit that NICE will examine interventions aimed at, for example,     prevent STIs.
                                    delaying sexual activity or reducing the number of partners.
                                    The nature and possible impact of interventions post-conception
                                    should be made more explicit. Most importantly, the nature of
                                    termination provision (which would clearly fall within the scope of a
                                    one-to-one intervention) may have an impact on decisions taken
                                    prior to conception and, consequently, on pregnancy and STIs.
                                    There is considerable research from the States on, for example, the      It is likely the issue of confidentiality
                                    impact of removing confidentiality in abortion provision for minors      will be raised in the literature.
                                    on conception rates. Confidentiality is usually removed with the         Literature from the USA will be
                                    intended aim of reducing teenage pregnancy rates and this would          included in the review.
                                    therefore be an important body of evidence for the NICE guidance
                                    to cover. Although the issue of mandatory confidentiality may lie
                                    outside the scope of the NICE guidance, an assessment of this
                                    body of evidence is likely to be useful in formulating NICE guidance
                                    on best practice for doctors providing terminations to minors.

                                                                        17
    Stakeholder            Section                              Comments                                                   Response
                           number              Please insert each new comment in a new row.                     Please respond to each comment

Nottingham University   4.4          It is unclear why the NICE guidance should necessarily reflect the       Wording in the scope will be amended
Business School                      Department of Health guidance on the provision of advice and             to ‘guidance from the Department of
                                     treatment to young people under 16 on contraception, sexual and          Health and DfES will be taken into
                                     reproductive health (see paragraph 2 of 4.4). Presumably it is           account’.
                                     possible that a review of the evidence by NICE would suggest that
                                     the DOH guidance needs re-visiting. This may just be a problem
                                     with the current wording of this paragraph.
Nottingham University   4.6          The interim measures suggested for pregnancy/STI are very                The outcome measures used will
Business School                      imperfect and uncertain indicators. For example, several                 reflect those which are found in the
                                     programme evaluations have found increases in condom use & no            literature reviewed.
                                     change (or even delayed) sexual activity but no reductions in
                                     pregnancies. A possible reason may be changes to the nature of
                                     sexual activity associated with increased condom use. In almost
                                     every case, it is impossible to be certain how changes in the interim
                                     measures will map onto the primary health outcomes.
                                     Consequently, I think the scoping document should be explicit that
                                     much greater weight will be placed on research that evaluates
                                     primary health outcomes. It may be that a consequence of this is
                                     that the guidance will be characterised by a high level of uncertainty
                                     regarding the weight of evidence.
Nottingham University   4.6 & 4.2    Following on from the previous point, using increased condom use         As above response to 4.6.
Business School                      as an interim measure has particular problems in the context of
                                     STIs. Specifically, its use is only appropriate for those infections
                                     against which condoms provide significant protection. The existing       Noted.
                                     evidence base suggests that the extent of protection provided by
                                     condoms varies quite significantly across different infections and, in
                                     some cases, the evidence on the level of protection is simply very
                                     limited.
                                     It would be inappropriate to use this as an intermediate measure         Noted.
                                     without some reference to and assessment of the evidence on the
                                     efficacy of condoms in preventing each STI. In turn, this suggests
                                     that the final sentence of Specific Intervention 1 (in Section 4.2)
                                     needs re-phrasing.


                                                                        18
    Stakeholder            Section                              Comments                                                   Response
                           number              Please insert each new comment in a new row.                     Please respond to each comment

Nottingham University   4.9.2        QUALYs are a useful tool but their application in the context of         Agreed. The NICE Health Economics
Business School                      health outcomes that potentially lead to a new life would raise some     team will need to consider this issue.
                                     particularly tricky methodological issues. It would be useful to have
                                     some indication in the Scope that these issues have been thought
                                     through.
Darlington PCT          3 general    When identifying those most at risk of poor sexual health could you      The scope includes a full list of
                                     also reference the evidence base that leads you to mention these         references.
                                     groups
Darlington PCT          4.1          Identifies that those involved in delivering sexual health               The issue of a knowledge/skills
                                     interventions come from a range of organisations – should this           framework is an important one.
                                     guidance therefore also identify (somewhere within the paper) a          However, it is outside the remit of this
                                     baseline skills/knowledge/framework for practitioners which would        scope which focuses on one-to-one
                                     include legislation to ensure consistency, less risk of mixed            interventions. There is the facility on
                                     messages, poor practice and negative full blown media interest that      the NICE website to suggest topics for
                                     sexual health services sometimes attracts                                consideration for future guidance at:
                                                                                                              www.nice.org.uk/page.aspx?o=topics
                                                                                                              uggest
Darlington PCT          4.2          Not sure how many years of evidence is being considered but could        Specific methods and procedures for
                                     there also be some indication as to how work is carried out to           reviewing the evidence will be
                                     enable young people/other high risk groups to make the transition        provided in detail in the forthcoming
                                     from specialist outreach/screening etc interventions to accessing        methods and procedures manuals,
                                     mainstream providers (e.g.: sexual health issues including               due to be published in December.
                                     termination of pregnancy for groups in their early 20’s is increasing)
                                     This group may have been targeted in their mid teens when the            Thank you for this observation.
                                     teenage pregnancy strategy first began but seem to have missed
                                     the message.
                                     This question is therefore raised ‘has increased prevention/sexual
                                     health intervention services reduced STI’s/pregnancies etc’? what
                                     would NICE forecast be for reduction in demand with a timeline in
                                     light of increased activity in prevention
                                     Can there be some clarification as Chlamydia Screening                   The NCSP is an opportunistic
                                     Programme (CSP) does not include those aged 25                           screening programme targeting
                                                                                                              sexually active young women and

                                                                        19
    Stakeholder     Section                              Comments                                                Response
                    number              Please insert each new comment in a new row.                  Please respond to each comment

                                                                                                    men under 25 years of age. (DH
                                                                                                    (2004) NSCP in England Programme
                                                                                                    Overview. P13.)
Darlington PCT    4.3         Appreciate that not all interventions can be covered in one           This will depend on the Department of
                              document – could there be some indicator as to when these             Health referring the work to NICE.
                              interventions will be covered.
                              Point 3 in this section is a priority and should be covered
Darlington PCT    4.4         Can the assessment also include clear guidance for those working      It is anticipated that this will be
                              for or in education regarding the provision of information and        included in the guidance.
                              referring on of young people to sexual health services?
Darlington PCT    4.6         Could the outcome measures also identify:                             Outcome measures as identified in
                                  Sexually diverse groups lesbian, bisexual and transgendered       the scope will be looked at in relation
                                                                                                    to any groups identified in the
                                                                                                    literature.
                              The involvement and retention of young men within a service           The scope has been amended to
                                                                                                    include uptake of services as an
                                                                                                    outcome measure for both men and
                                                                                                    women.
Darlington PCT    General     I could not see any mention of young people with disabilities/sen’s   We agree that it is important to be
                  Comment                                                                           inclusive of people with disabilities.
                                                                                                    Interventions which target people with
                                                                                                    disabilities will not be excluded from
                                                                                                    the literature searches.
RCGP              General     The RCGP welcomes the fact that the proposed guidance focuses         Thank you.
                              on broad sexual health issues encompassing both STIs and
                              pregnancy. The DOH has been expressing concerns for many
                              years on the rising incidence of STIs as well as under 18
                              pregnancies, and with good reason. The UK has the highest
                              incidence of teenage pregnancies in Europe, with levels twice those
                              of Germany, thee times those of France and six times those of
                              Holland.
                              However the advantages of this approach are limited due to the        Noted. The referral from DH specified
                              differential age range under consideration. Unintended                under 18 conceptions.

                                                                 20
   Stakeholder     Section                              Comments                                                    Response
                   number              Please insert each new comment in a new row.                      Please respond to each comment

                             pregnancies are not restricted to under 18 year olds, and sexual
                             behaviour associated with unintended pregnancy is also associated
                             with increased rates of STI. An alternative approach might be to
                             amend the scope to include unintended pregnancy and STIs in
                             young people up to the age of 25.
RCGP             General     It is also important that we don't stigmatise teen pregnancies any        Agreed.
                             more than they are already and that we don't use a medical model
                             for trying to reduce burden of STIs and unwanted pregnancy here:
                             the reason why far more social class five girls get pregnant more
                             than social class ones are multiple and are not all to do with access
                             to contraception.
                             We recognise that this scope is for Public Health Intervention            We recognise the range of
                             Guidance and focuses on one to one interventions (2). Whilst we           interventions that could be
                             welcome the fact that this will be specifically relevant to the general   considered, but due to time and
                             practice, we would emphasise that such interventions will only have       resource constraints NICE has
                             limited impact in relation to the broader social, cultural and cultural   decided to focus this guidance on
                             environment. We would advocate the production of Public Health            one-to-one interventions. There is the
                             Programme Guidance to complement this approach and to provide             facility on the NICE website to
                             the context for successful face to face interventions                     suggest topics for consideration for
                             . The scope recognises that under 18 pregnancies may not be               our future guidance at:
                             unintended or unwanted, but it is not clear about how these will be       www.nice.org.uk/page.aspx?o=topics
                             distinguished, and the scope still identifies overall conception rates    uggest
                             as the primary outcome. Where possible we would recommend
                             that the outcome used should be unintended pregnancy. Rates of            Noted. The measures used will be
                             termination of pregnancy can be used as a surrogate marker of this        dependent on the measures used in
                             within some research.                                                     the reviewed literature.
RCGP             General     There is little emphasis on young heterosexual men within the draft       We agree and note the paucity of
                             scope. Whilst young heterosexual men are at less direct risk of the       research with young heterosexual
                             complications of high risk sexual behaviour, they are key to the          men. We will examine this group very
                             transmission of STIs and initiation of pregnancy! Moreover they are       carefully.
                             difficult to engage in a one to one setting and require a different
                             approach to that for young women. It is important that the guidance
                             explicitly acknowledges these differences and examines the


                                                                 21
   Stakeholder       Section                              Comments                                               Response
                     number              Please insert each new comment in a new row.                 Please respond to each comment

                               research evidence for effective interventions in this group.         Due to limitations in resources it was
                               The guidance needs to explicitly include screening for other         decided not to cover screening other
                               sexually transmitted infections in individuals diagnosed as having   than for chlamydia. Screening is
                               one. The importance of this is emphasised by the fact that co-       currently outside the remit of NICE
                               morbid HIV infection is less frequently detected in individuals      and is overseen by the National
                               diagnosed as having chlamydia infection in general practice          Screening Committee.
                               compared with GUM clinics.
RCGP             3             In addressing the rate of under 18 pregnancies, it is essential to   Noted.
                               consider the evidence relating to limiting factors for seeking
                               contraception (eg lower use in lower socio-economic groups (1),
                               anxiety about confidentiality and confusion over legal issues (2).
                               1)http://www.statistics.gov.uk/StatBase/ssdataset.asp?vlnk=4985&
                               More=Y
                               Krishnamoorthy N, Ekins-Daukes S, Colin R Simpson C et al.
                               Adolescent use of the combined oral contraceptive pill. A
                               retrospective observational study. Arch Dis Child.2005; 0:
                               200405917
                               It could be noted that homes without a father also have an           Noted.
                               unusually high burden of teen pregnancy.
                               There is also evidence that contrary to intuitive inclinations,
                               increasing provision of inappropriate services may make sexual
                               health & inequalities worse.
                               E.g. Paton D Journal of Health Economics
                               2002 21 207-225
RCGP             4.2.1         Through EC intuitively seems an effective approach to date no        Noted.
                               research has shown any benefit in lowering unplanned pregnancy
                               rates.
                               See Glasier A et al
                               “Contraception” 2004 69 361-6
                               Raine T et al
                               JAMA 2005 293 54-62
                               Glaasier A et al
                               NEJM 19996 339 1-4


                                                                 22
   Stakeholder      Section                                Comments                                                   Response
                    number                Please insert each new comment in a new row.                     Please respond to each comment

                                Condoms only offer substantial protection against some STIs              Noted.
                                notably HIV. However they offer little or no protection from eg HPV.
                                HPV vaccination is important here as well as education about the
                                high risk of inconsistent condom use, as well as non use.
                                See e.g. Genuis SJ et al
                                AM J of O&G 2004 191 1103-1112
                                Consideration should be given to the problem that the best               Noted.
                                contraceptives (COC, Depos etc) do not protect against STI’s
                                Conversely condoms & other barriers though offering some
                                protection against STI’s, have a higher failure rate for pregnancy
                                than other methods.
                                The committee must consider the evidence on whether allowing
                                GPs to prescribe condoms will improve the uptake of condom use
                                and a thereby reduction in rates of STIs.
                                The scopes states that it will not look at the efficacy of individual
                                methods of contraception. However, it should consider the effect of
                                limited availability of the whole range of contraception methods on
                                uptake and pregnancy rates.
RCGP             4.2            Consideration should be given to the problem that the best               Noted.
                                contraceptives (COC, Depos etc) do not protect against STI’s
                                Conversely condoms & other barriers though offering some
                                protection against STI’s, have a higher failure rate for pregnancy
                                than other methods.
RCGP             4.2.2          The issue of confidentiality and partner notification should be          Agreed.
                                considered in the guidance as more and more G-U work is being
                                transferred from STI clinics to primary care.
RCGP             4.2.3 (4.3).   The scope covers screening for Chlamydia and specifically                Due to limitations in resources it was
                                excludes screening for HIV, syphilis and hepatitis B.                    decided not to cover screening other
                                 It is unclear why these other infections are excluded, and screening    than for chlamydia. Screening is
                                for gonorrhoea is not specifically addressed.                            currently outside the remit of NICE
                                The role of screening for infections as part of routine antenatal care   and is overseen by the National
                                needs to be considered. Screening for chlamydia should not be            Screening Committee.
                                confined to patients over the age of 16.

                                                                   23
    Stakeholder        Section                                  Comments                                                     Response
                       number                  Please insert each new comment in a new row.                       Please respond to each comment

RCGP                4.2.3           Some research has shown high recurrence rates after screening, &            Noted.
                                    intervals of 6-12 months are recommended, if no change in sexual
                                    behaviour occurs concurrently with screening.
                                    See Lee VF, Tobin JM
                                    Int J of STD & Aids 2004 15 944-6
RCGP                4.4             We would welcome the emphasis on the populations suggested.                 Thank you.
RCGP                4.8.5           In addition to those proposed, research questions need to be                We anticipate that to some extent this
                                    included:                                                                   will be covered in considering the role
                                    Evaluation of the level and nature of training of the intervener            of the intervener.
RCGP                4.8.5           Integration and communication between complementary services                We agree that this is more appropriate
                                    (e.g. co-location of school / GP / GUM services) – i.e does                 to programme guidance.
                                    improved integration of services influence effectiveness? (this may
                                    be more appropriately covered within Programme Guidance)
RCGP                Section 4.8.5   Acceptability and accessibility - relating to willingness of young          Noted.
                                    people to attend services for sexual health advice. This is likely to
                                    depend on a variety of factors including setting and type of service,
                                    but also choice of gender of the intervener (not necessarily gender
                                    per se).
                                    Holistic approaches – whether interventions that include broader
                                    aspects of health care (such as alcohol / drug misuse and mental
                                    health issues) are more effective than those that focus on sexual
                                    health in isolation.
RCGP                Section 4.8.5   There are specific issues regarding repeat unintended pregnancy             Noted.
                                    and STIs. The research evidence in this area is limited but needs
                                    to be considered separately to primary prevention and first
                                    presentation.
Faculty of Family   4.2             It is not clear to me whether you plan to include so-called ‘novel’         We will only consider screening for
Planning &          Interventions   strategies for screening for STI such as postal testing kits or             chlamydia, but within this we will
Reproductive                        internet invitations. It would be most helpful if an evaluation of these    consider novel approaches.
Healthcare                          could be included (including cost-effectiveness)
Faculty of Family   4.5             It is vital to look at data from other countries since little exists from   NICE will consider data from
Planning &                          UK studies. Data from developed countries may be more useful                worldwide literature.
Reproductive                        than from developing country settings.

                                                                         24
    Stakeholder           Section                              Comments                                                    Response
                          number              Please insert each new comment in a new row.                      Please respond to each comment

Healthcare
Jewish AIDS Trust       General     NICE is developing guidance on public health, recommending types          Due to limitations of resources this
                                    of activity usually provided by local health organisations to help        Intervention guidance will not look in
                                    promote and maintain a healthy lifestyle, or reduce the risk of           depth at the broader determinants of
                                    developing an STI.                                                        sexual health, a task which is more
                                                                                                              appropriate to Programme Guidance.
                                    But the wider determinants of health, including education and             The topic referral from the Department
                                    cultural differences are not included in the research.                    of Health specified that ‘interventions’
                                                                                                              should be the focus of this guidance
                                    The Influence of culture and religion must be take into the equation,     (see scope section 1). There is the
                                    when looking sexual health. People who adhere strictly to their           facility on the NICE website to
                                    faith may have little if any sexual health education. If they then fail   suggest topics for consideration for
                                    to follow the strict teaching of their faith they become vulnerable.      our future guidance at:
                                                                                                              www.nice.org.uk/page.aspx?o=topics
                                    Providing one-to-one interventions without considering the                uggest We would expect that at some
                                    influences of culture and religion amongst many other social issues,      point in the future NICE will be asked
                                    which affect an individual will greatly reduce the effectiveness of the   to look at these issues
                                    intervention. Human beings are complex. More than most other
                                    issues, sexual health interventions cannot be looked in isolation         One-to-one educational interventions
                                    from the influences that affect a person's life.                          will be considered.

The Royal Society for   4.1         The RSPH considers the intended audience as appropriate,                  Thank you
the Promotion of                    particularly where it includes non-professionals and those working
Health                              in non-health specific services.
                                    Considering evidence on inequalities in health, particularly              Agreed.
                                    regarding social class and ethnicity will be of benefit. It would also
                                    be of benefit to look at social exclusion factors, not solely social
                                    class, including for example, educational attainment levels.
The Royal Society for   4.2         Could direct one-to-one intervention not include testing as well as       This guidance will not cover testing
the Promotion of                    screening, or is this assumed. For example, pregnancy and STI             and screening, other than for
Health                              testing?                                                                  chlamydia, however, prevention
                                    In addition to intervention in non-NHS settings it may be necessary       interventions delivered at the time of
                                    and beneficial to consider non-statutory services including               testing will be considered.

                                                                        25
    Stakeholder           Section                              Comments                                                 Response
                          number              Please insert each new comment in a new row.                   Please respond to each comment

                                    community (both geographical and of interest) and youth based
                                    organisations and their interventions.
The Royal Society for   4.4         The RSPH considers the population appropriate.                         Thank you.
the Promotion of
Health
The Royal Society for   4.6         The RSPH considers the use of research on both intermediate and        Thank you.
the Promotion of                    primary health outcomes to be appropriate in this instance.
Health
The Royal Society for   4.7         The RSPH considers it essential that the audience for this guidance    Agreed. NICE anticipate that the
the Promotion of                    extend beyond health professionals and that the final guidance be      guidance will be useful to a wide
Health                              appropriate to those without medical knowledge and knowledge of        range of practitioners.
                                    technical medical language and terminology. This is due to the
                                    multi-disciplinary nature of the sexual health workforce.
                                    The detailed list of target audiences is appropriate and in the case
                                    of schools and colleges and voluntary services may also consider
                                    counsellors and psychologists. Those working on helplines in
                                    community and voluntary settings would also be of benefit to
                                    include.
                                    Health Trainers, currently operating in pilot areas, will also be an
                                    appropriate audience.
The Royal Society for   4.8         The RSPH considers the overarching research question to be             Thank you.
the Promotion of                    appropriate.
Health                              The ten elements identified to examine effectiveness of
                                    interventions are considered appropriate by the RSPH .
Family Education        General     The character and context in which one-to-one health interventions     Noted.
Trust                               take place is of crucial importance. It should not be assumed that
                                    any targeted intervention is better than none.
                                    Given that sexual abstinence is the only sure way to meet both of
                                    the aims, one-to-one interventions that encourage sexual
                                    relationships outside the context of a lifelong committed marriage
                                    and encourage patients to understand the physical and emotional
                                    benefits of exercising self-restraint should be included within the
                                    scope.

                                                                       26
    Stakeholder      Section                                Comments                                                   Response
                     number                Please insert each new comment in a new row.                     Please respond to each comment

                                 Within a climate which has cheapened sex and presented it as a
                                 casual activity, practitioners and educators in one-to-one
                                 interventions are well-placed to raise the attitudes and aspirations
                                 of their clients/patients.
                                 Our leaflet, Sexual Spin (copy to follow in the post), may serve as a    Thank you.
                                 useful guide to practitioners in this area and is suitable for passing
                                 on to clients/patients for further reflection and consideration.
Family Education   Section 4.2   The emphasis on condom provision in this section implies a level of      It is outside of the remit of this
Trust                            reliance on this method of contraception that is not supported by the    guidance to consider the effectiveness
                                 data. We would suggest that the scope should take account of the         of condoms. Resource and time
                                 user and method failure rates associated with condom usage and           constraints mean that we can only
                                 the evidence which indicates that condoms provide less protection        consider the interventions themselves.
                                 against some STIs than others.                                           However, this background information
                                                                                                          will be used to frame the
                                                                                                          recommendations.
Family Education   Section 4.4   The statement that the resulting guidance ‘will reflect the guidance     Wording in the scope will be amended
Trust                            provided by the Department of Health’ appears to prejudge the            to ‘guidance from the Department of
                                 outcome of the exercise and possibly render it superfluous. It           Health and DfES will be taken into
                                 appears to preclude the possibility that NICE’s analysis might draw      account‘.
                                 different conclusions from those previously reached by the
                                 Department of Health.
Family Education   Section 4.6   We suggest that knowledge and access to resources are not                The outcome measures used will be
Trust                            necessarily measurements of success. Consideration needs to be           dependent on those used in the
                                 given to possibility that the perceived reduction in risk afforded by    reviewed literature.
                                 contraception and emergency hormonal contraception may provide
                                 some young people with an incentive to become sexually active.
                                 Particular attention should be given to the operation of the risk
                                 displacement principle where contraceptive advice and provision is
                                 offered to a minor in the context of a confidential one-to-one
                                 intervention.




                                                                    27
    Stakeholder           Section                              Comments                                                    Response
                          number              Please insert each new comment in a new row.                      Please respond to each comment

Roche Diagnostics Ltd   General     Section 2.0 of the draft scope states that the intervention guidance      The scope has been amended to
                                    will focus on “one to one or face to face interactive interventions.”     include all approaches to chlamydia
                                    This point is repeated in section 4.1. However, section 4.2 states        screening.
                                    that the scope will include chlamydia screening of young men and
                                    women in a range of non-GUM settings, including opportunistic
                                    screening.
                                    We are concerned that there is a potential conflict between these
                                    two statements, and that the review of chlamydia screening may
                                    only focus on one to one interventions instead of examining the full
                                    range of options for delivering the screening programme. The
                                    opportunistic nature of the programme – and that the fact that it is
                                    designed to reach a target population which can be difficult to
                                    contact – mean that one to one interventions may not be the most
                                    appropriate or effective way of communicating with this audience.
                                    Given this, we would strongly recommend the following:
                                     The Centre for Public Health Excellence does not just consider
                                         one to one interventions when assessing the chlamydia
                                         screening programme, so that it can provide the most
                                         comprehensive and useful advice to underpin the roll out of the
                                         programme.
                                     It specifically examines the role that pharmacies can play in
                                         delivering chlamydia screening services, given the pilot scheme
                                         that will be starting shortly in London. This will ensure that the
                                         NHS receives co-ordinated and up to date advice on the options
                                         available for rolling out the programme and achieving the best
                                         possible results.
                                     We hope that NICE will also assess the other pilot projects that
                                         have recently taken place in primary care settings, such as the
                                         Men and Chlamydia Project run by the Men’s Health Forum in
                                         Telford which was highlighted in Choosing Health Through
                                         Pharmacy published by the Department of Health in April 2005
                                         (http://www.dh.gov.uk/assetRoot/04/10/74/96/04107496.pdf



                                                                        28
   Stakeholder            Section                                  Comments                                                    Response
                          number                  Please insert each new comment in a new row.                      Please respond to each comment

fpa (Family Planning   3 The need      p4 ‘other consequences of poor sexual health’: this section comes          Agreed. We will amend the scope to
    Association)       for guidance    across as very female-oriented; it needs to be clearer that the            reflect these points.
                                       effects of poor sexual health also impact on men, and have
                                       negative consequences for male sexual health and fertility
                                       p5 inequalities in sexual health:
                                       bullet 1: need to be clear which data referring to, as only 2003 data
                                       available for HIV but 2004 data for other STIs (which are referenced
                                       on pages 3-4)
                                       p5 inequalities in sexual health:
                                       bullet 2: why does this point mention NI but omit reference to
                                       Scotland? It should either include Scotland (now covered by HPA
                                       data) if giving a UK-wide picture, or just refer to England and Wales
                                       if the guidance is for these countries only
fpa (Family Planning   Trends          p6: this should also reference drug and alcohol misuse and its             Agreed.
    Association)                       impact on sexual behaviour and risk-taking
fpa (Family Planning   4.2             p8:paragraph 3: must be clear how ‘brief advice’ is defined in the         Agreed.
    Association)       Interventions   context of direct one-to-one interventions
                                       p8:section 1, bullet 1: this should refer to ‘advice on and provision of   Agreed.
                                       the range of contraceptive methods, including both methods of
                                       emergency contraception’                                                   Agreed.
                                       p8:section 1, bullet 3: this should be rephrased ‘e.g. at pregnancy
                                       testing, at pregnancy counselling and at antenatal checks’ – it is not
                                       the time to have these interventions at abortion (NB please also
                                       note for reference that it is now more commonly accepted to use
                                       the term abortion rather than termination of pregnancy), but
                                       pregnancy counselling would cover discussions which lead to aborti
                                       p9: section 3: need to add pharmacy to list of NHS and non-NHS             Agreed.
                                       settings where interventions take place, as pharmacists play an
                                       important role in the provision of one-to-one advice
fpa (Family Planning   4.5             Will cross country comparisons be within the UK or across a wider          We are keenly aware of the
    Association)       Comparators     geographical remit/worldwide? If worldwide data is used it will be         complexities, but to a large extent the
                                       important to take into account cultural differences which will have        data used for comparison will depend
                                       an impact on the effectiveness of different interventions                  on the data revealed by the literature.

                                                                           29
    Stakeholder          Section                                 Comments                                                   Response
                         number                 Please insert each new comment in a new row.                     Please respond to each comment

fpa (Family Planning   4.6 Outcome    paragraph 3, intermediate outcome measures: this should also             Noted.
    Association)       Measures       include increased and effective use of emergency contraception
                                      paragraph 4, primary health outcomes: it will be important to take
                                      care when considering the primary health outcomes of interventions
                                      – both teenage pregnancy rates and rates of sexually transmitted
                                      infections are affected by a complex range of factors, and it may        Noted.
                                      therefore be difficult to draw a direct link between specific
                                      interventions and rates of TP and STIs
fpa (Family Planning   4.8 Research   There should be a question here that addresses the provision and         Noted.
    Association)       Questions      role of ‘back up’ information, which supports improved
                                      understanding and use of contraceptive methods, for example (for
                                      reference, the Fertility Regulation Group has just done a Cochrane
                                      Review in this area which addresses interventions around
                                      improving adherence to contraceptive use)
fpa (Family Planning   General        There is a notable lack of patient voice within sexual health; it will   NICE involves the public and patients
    Association)                      therefore be vitally important to engage the public/patients in a        in all of its consultation phases.
                                      sensitive way to ensure their involvement in the development of this
                                      guidance
Durham Dales Primary Appendix A       Pleasing to see this paragraph as it outlines the groups with the        Thank you.
     Care Trust                       greatest burden of sexual ill health. National guidelines should allow
                                      flexibility so that sexual health services can be targeted to specific
                                      local communities within a locality. E.g. Nationally we are told of
                                      new diagnosis of HIV within the straight community have overtaken
                                      new infections within the gay community, however within County
                                      Durham and Darlington men who have sex with men are still the
                                      highest group affected by HIV.
Durham Dales Primary 4.1              Mentioned in this section but throughout the document. Recognition       Agreed.
     Care Trust                       of other organisations that deliver sexual health services is vital
                                      especially as PCTs are envisaged to become commissioner rather
                                      than provider organisations. Quality assurance / standards will have
                                      to be reflected within Service Level Agreements between PCTs (as
                                      commissioners) and sexual health services (as providers).
Durham Dales Primary 4.2              Clarification needed regarding Chlamydia screening age range –           The NCSP is an opportunistic

                                                                         30
    Stakeholder          Section                              Comments                                                    Response
                         number              Please insert each new comment in a new row.                      Please respond to each comment

     Care Trust                    16-25? The national screening programme is 16-24.                         screening programme targeting
                                                                                                             sexually active young women and
                                                                                                             men under 25 years of age. (DH
                                                                                                             (2004) NSCP in England Programme
                                                                                                             Overview. P13)
Durham Dales Primary 4.3           Slightly concerned that the numbered interventions that will not be       We agree that this is important. But
     Care Trust                    covered – especially point three. Tackling the wider determinants of      because of resource and time
                                   Sexual ill health is essential from a prevention perspective – we will    constraints, we are unable to cover
                                   not stem the flow of increased STI/HIV rates if this is left out of the   this area. There is the facility on the
                                   guidelines.                                                               NICE website to suggest topics for
                                                                                                             consideration for our future guidance
                                                                                                             at:
                                                                                                             www.nice.org.uk/page.aspx?o=topics
                                                                                                             uggest
Durham Dales Primary 4.6           Reflecting on the points made with Appendix A. Could there be             The outcome measures will
     Care Trust                    outcome measures to encompass the Lesbian Gay Bisexual and                encompass all of these populations.
                                   Transgender communities and people affected by HIV?
 National Aids Trust   General     HIV needs to have a stronger profile in the scope document.               Agreed. The scope has been
                                   Elsewhere it is often identified separately to other STIs and as a        amended to clarify this.
                                   result some interpret the phrase 'STIs' to mean STIs other than HIV.
 National Aids Trust   Section 2   To clarify the place of HIV, as discussed above, we propose in the        Agreed.
                                   paragraph marked 'a)', that the phrasing be amended to read, "to
                                   develop public health intervention guidance on the reduction of
                                   sexually transmitted infections (STIs), including HIV".[Bold to
                                   identify addition]




                                                                       31
    Stakeholder          Section                                   Comments                                                       Response
                         number                   Please insert each new comment in a new row.                         Please respond to each comment

 National Aids Trust   Section 2 and   The paragraph marked 'b)' states that a second function of the                Noted. We do not wish to de-prioritise
                       3               guidance, in addition to providing recommendations for good                   HIV.
                                       practice [see 'a)'], will be to "support measures to achieve the
                                       government targets..".There then follows an extended section on
                                       the national targets around sexual health. HIV is not included either
                                       in the national PSA targets nor in National Standards, Local Action,
                                       and this omission has been a matter of some controversy. It would
                                       be wrong for the NICE assessment to mirror recent targets in
                                       deprioritising HIV. The current place of the 'targets section' in the
                                       scope document inadvertently suggests this might happen.
                                       The seriousness of HIV as a condition, the steep rise in new
                                       diagnoses and the urgency of the need for an effective response all
                                       mean that the opening sections of the report need to highlight the
                                       importance of HIV in the assessment which is to be undertaken by
                                       NICE. To that end, we propose that Section 2 'Background' consist
                                       simply of the two paragraphs currently marked 'a)' and 'b)'. Section
                                       3 'The need for guidance' should have at the end the paragraphs on
                                       targets currently found in Section 2. It is striking that the first part of
                                       Section 3 gives epidemiological data on all STIs apart from HIV -
                                       another example of sidelining of HIV in the document. Information
                                       and data on HIV must be added to make clear the need for
                                       guidance in this area.
National Aids Trust    Section 4       The capturing of research on health inequalities is welcome. There            Noted.
                       [4.1]           has been important recent work by organisations such as Sigma
                                       Research on social class and ethnic inequalities within gay men's
                                       sexual health work1, and these should be reviewed.




                                                                             32
   Stakeholder          Section                              Comments                                                  Response
                        number              Please insert each new comment in a new row.                    Please respond to each comment

National Aids Trust   Section 4   Interventions assessed should include counselling/discussion            Noted.
                      [4.2]       around Post Exposure Prophylaxis; one-to-one
                                  counselling/discussion on helpline or by email; one-to-one
                                  interventions as part of the ongoing clinical management of people
                                  living with HIV. It should be made clear that interventions include
                                  opportunities linked or related to the HIV screening process, even if
                                  the screening itself is not included. The description of under 18
                                  interventions at '1.' of 4.2 biases the assessment towards a
                                  contraceptive and heterosexual model e.g. "Advice about the use of
                                  condoms plus other forms of contraception for the prevention of
                                  conception and STIs". There has to be consideration of
                                  interventions aimed at gay young men in particular around STI and
                                  HIV prevention, a group who are at present very poorly served and
                                  invisible in the current scope document. Interventions in the primary
                                  care setting are particularly important given the ambitions of the
                                  'Choosing Health' White Paper to roll out sexual health services into
                                  the primary care setting. Interventions relating to prevention of HIV
                                  will for the most part involve linking information and referral on
                                  sexual health services to the contraceptive services currently
                                  provided in primary care settings. There has recently been
                                  interesting work on HIV and wider sexual health service provision in
                                  primary care and GP settings and this should be captured.
                                  We regret that group based interventions are not to be covered
                                  since this effectively excludes an important forum for African people
                                  especially, and one where guidance is urgently needed.
                                  Consideration should be given to information available on other
                                  one-to-one interventions which can have a sexual health dimension
                                  for Africans in the UK, including discussions with faith
                                  leaders/pastors and the role of immigration professionals in health     Thank you. These observations will be
                                  screening advice. Interventions should not be considered too            very helpful for the PHIAC in
                                  'vertically' and solely in terms of the express and immediate aims of   developing the recommendations.
                                  the intervention. Particularly around sexual health, interventions
                                  around Chlamydia or conception, for example, could well have
                                  implications or opportunities for HIV.
                                                                     33
   Stakeholder             Section                                 Comments                                                    Response
                           number                 Please insert each new comment in a new row.                      Please respond to each comment

National Aids Trust     Section 4       There is often an assumption in prevention work that interventions        Interventions targeting people with
                        [4.4]           target those in vulnerable groups who are currently uninfected. In        HIV will be considered.
                                        the case of an incurable, long-term condition such as HIV there is a
                                        growing belief in the HIV sector that some of the key interventions
                                        to prevent further infection should be targeted at people living with
                                        HIV, and there has been interesting work internationally, including
                                        in the USA, on this basis ("Positive Prevention"). This is not limited
                                        to partner notification or post-test discussion, and the scope
                                        document could usefully make clear that effective one-to-one
                                        interventions are for both infected and uninfected people.
                                        As has been stated above, it will be important in looking at the
                                        various population groups identified in this section to be sensitive to
                                        the way they interrelate e.g. BME young gay men.
                                        The category of 'refugee and asylum seekers' needs to be                  We will reconsider the wording used
                                        reformulated or added to. One of the groups where there is most           for this.
                                        concern at present is that of failed asylum seekers and other
                                        undocumented migrants who, though they are living here, are
                                        ineligible for free HIV treatment on the NHS with implications for the
                                        interventions which they can access to reduce the likelihood of
                                        onward transmission of HIV. A word such 'migrant', or something
                                        similar, would capture this key vulnerable population and not limit
                                        interventions to those the Government recognises as having a legal
                                        right to be here.
National Aids Trust     Section 4       Another intermediate outcome measure could usefully be                    The outcome measures used will
                        [4.6]           'appropriate and timely treatment of STIs and HIV'.                       reflect those found in the literature.
British Psychological   4.2             Mention “counselling (including CBT)” & 1:1 interventions. Will           One-to-one interventions in GU and
        Society         Interventions   counselling & Clinical Psychology interventions in the GU clinics &       other areas will be considered, but not
                        & Whole         HIV centres be looked at of interventions aimed at reducing the           group interventions. There is the
                        document        behaviours behind the transmission of STI & Pregnancy.                    facility on the NICE website to
                                        Psychologists are behavioural scientists who have much to offer           suggest topics for consideration for
                                        both directly and indirectly in the above through staff training and      our future guidance at:
                                        research and consultation.                                                www.nice.org.uk/page.aspx?o=topics
                                                                                                                  uggest.


                                                                            34
    Stakeholder            Section                              Comments                                                    Response
                           number              Please insert each new comment in a new row.                      Please respond to each comment

 London Network for    1             We feel that the proposal should better reflect that it also refers to    Agreed. The scope will be amended
Nurses and Midwives:                 HIV, therefore we request that it is made more explicit in the            to clarify this.
Sexual Health Group                  document
 London Network for    2             It mentions in the document that it is focusing on ‘face-to-face          The focus is on one-to-one
Nurses and Midwives:                 interactive interventions. However there are two points we would          interventions, rather than face-to-face
Sexual Health Group                  like to make:                                                             which has now been removed from
                                         1) There may be aspects of group work or techniques, which            the scope. Group interventions will not
                                             may have been appraised in the literature, which could            be considered in this guidance. There
                                             prove beneficial and could be applied in a face-to-face           is the facility on the NICE website to
                                             consultation.                                                     suggest topics for consideration for
                                     It might be useful to follow up your initial assessment of face-to-face   our future guidance at:
                                     interventions with group work, as this is a very important and often      www.nice.org.uk/page.aspx?o=topics
                                     affective intervention especially with minority populations who are       uggest We would expect that at some
                                     disproportionally affected with poor sexual health.                       point in the future NICE will be asked
                                                                                                               to look at these issues.
 London Network for    4.3           The public health role of GUM clinics needs to be acknowledged as         Agreed. The scope has been
Nurses and Midwives:                 a lot of work is done face-to-face with the patients in the clinic        amended.
Sexual Health Group                  setting PEPSI should be seen as a opportunity for interventions as
                                     this group of patients may be more open to behaviour change
  Royal College of     General       With a membership of over 370,000 registered nurses, midwives, Noted.
     Nursing                         health visitors, nursing students, health care assistants and nurse
                                     cadets, the Royal College of Nursing (RCN) is the voice of nursing
                                     across the UK and the largest professional union of nursing staff in
                                     the world. The RCN promotes patient and nursing interests on a
                                     wide range of issues by working closely with Government, the UK
                                     parliaments and other national and European political institutions,
                                     trade unions, professional bodies and voluntary organisations.
                                     Thank you for the opportunity to comment on the draft scope of this
                                     guidance. As an overall outcome the scope does not seem to
                                     include examining ease of access to 1:1 interventions. There are
                                     disparities not only nationally but also within Strategic Health
                                     Authorities and this will prove important when trying to determine
                                     why target groups do not access services.

                                                                         35
 Stakeholder          Section                                 Comments                                                  Response
                      number                 Please insert each new comment in a new row.                    Please respond to each comment

Royal College of   1.1 and         For clarity - would suggest that the short title reads “….under 18      Noted. NICE housestyle spells
   Nursing         general         year old” Note that there are a number of typing errors throughout      chlamydia with a lower case ‘c’.
                                   the document. Throughout the document STIs are mentioned but
                                   Chlamydia is the only one mentioned in detail. Chlamydia is
                                   generally spelled with capital C, whereas chlamydial is lower case.”
                                   new STIs were diagnosed” Technically, this is “new incidence (or
                                   new cases) of STIs were diagnosed”, as it reads as though they are
                                   new infections per se. In collaboration with the Department of
                                   Health and University of Greenwich, the Royal College of Nursing
                                   runs a distance learning course in Sexual Health Skills
                                   (www.rcn.org.uk/sexualhealthlearning ) which captures much of
                                   what the scope of the guidance is aimed at. A copy of the course        Thank you.
                                   flyer is attached for your information.
Royal College of   Page 4 New      696,419 unsure where these figures came from and need checking.         Figures will be checked and amended
   Nursing         STIs                                                                                    if necessary.
Royal College of   Primary         This will increase during the next 2-5 years as GU clinics all move     Noted.
   Nursing         outcomes        to NAAT tests for chlamydeous.
                   Reduction in
                   no of STIs
                   reported
Royal College of   3 (page 5)      Inequalities in sexual health: target group should also include         Noted.
   Nursing                         teenage parents.
Royal College of   4.1 &4.2        And including repeat pregnancies Excellent to see condoms being         Thank you.
   Nursing                         promoted as contra-infection as well as contraception.
Royal College of   4.3.2           Interventions which will not be included - General - Missed             Noted.
   Nursing                         opportunity to exclude the interventions around sex and relationship
                                   education and role of the family.
Royal College of   4.3.5 and 4.4   These are in conflict with each other, as targeting gay, bisexual and   Interventions for HIV prevention will
   Nursing                         other men who have sex with men for STIs but not HIV would              be considered. HIV screening will not
                                   probably be unethical, given: a) the current trends in encouraging      be considered as this is outside the
                                   HIV testing and b) the availability of HAART for those deemed           remit of NICE.
                                   necessary (obviously more beneficial through early testing)


                                                                      36
 Stakeholder         Section                                  Comments                                                Response
                     number                  Please insert each new comment in a new row.                  Please respond to each comment

Royal College of   Page 10         The Sexual Health Strategy gave clear markers/targets for these       Screening for these two infections is
   Nursing         Screening for   two infections and a missed opportunity if not excluded.              outside the remit of this guidance.
                   HIV and Hep
                   B
Royal College of   General         Other conception rates nationally are at < 19 and the current data    Noted. The referral from the DH
   Nursing                         available is under 19.                                                specified that the guidance should
                                                                                                         cover under 18 conceptions.
Royal College of   Page 10 4.3     Interventions which address the wider determinants of poor sexual     Although we are unable to address
   Nursing         No 4            health – another missed opportunity.                                  interventions which tackle the wider
                                   The majority of clients attending GUM receive 1-2-1 interventions     determinants (other than on a one-to-
                                   and it would be a missed opportunity if GUM were omitted              one basis), GU clinics will be included
                                                                                                         in the revised scope. There is the
                                                                                                         facility on the NICE website to
                                                                                                         suggest topics for consideration for
                                                                                                         our future guidance at:
                                                                                                         www.nice.org.uk/page.aspx?o=topics
                                                                                                         uggest We would expect that at some
                                                                                                         point in the future NICE will be asked
                                                                                                         to look at these issues.
Royal College of   Page 10 no      Appears to conflict with no 3 in 4.3 stating that reference will be   One-to-one interventions can be
   Nursing         4.4             given to those groups who are at the greatest risk of STIs and        consistent with addressing the wider
                                   teenage pregnancy and yet fails to address the wider determinants     determinants of health.
                                   of poor sexual health.
Royal College of   4.4 final       Special mention could be made here for the innovative work of         Noted.
   Nursing         paragraph       many school and young people’s nurses, for those working with all
                                   the groups identified here, especially young men in Young
                                   Offenders Institutions.
Royal College of   4.6 paragraph   Measuring knowledge is one thing, but what about (negative)           Noted.
   Nursing         3               attitudes towards such issues as condom use?
Royal College of   Page 11 4.7     Sexual Health Leads at strategic health authorities should be         Guidance will be appropriate for the
   Nursing         Target          included as they receive all new modernisation money for sexual       full range of practitioners both inside
                   audience        health.                                                               and outside of the NHS.


                                                                      37
 Stakeholder          Section                                 Comments                                                  Response
                      number                 Please insert each new comment in a new row.                    Please respond to each comment

Royal College of   4.7             In NHS: Teenage Pregnancy Co-ordinators sometimes sit within the        Guidance will be appropriate for the
   Nursing                         NHS rather than local authorities. Should it not include health         full range of practitioners both inside
                                   promotion specialists?                                                  and outside of the NHS.
Royal College of   4.7 bullet      School heads and teachers – to also improve the knowledge of            Guidance will be appropriate for the
   Nursing         point 3         young people - But best practice suggests this is an up-hill struggle   full range of practitioners both inside
                                   without engaging the help of parents (who have already been             and outside of the NHS.
                                   excluded in 4.3.2).
Royal College of   Appendix 2 –    Given what is said on HIV above, HIV cannot be ignored in the           We will not ignore HIV. The scope is
   Nursing         “syphilis”      transmission of other sexual infections, most particularly to gay,      being amended to reflect HIV more
                                   bisexual and other men having sex with men. If this group shows         clearly.
                                   such high incidence of other sexual infections, then obviously they
                                   are having unprotected sex, which is, by definition, open to the
                                   transmission of HIV. Statistical evidence also shows that in the UK,
                                   it is mainly white, under 24 year old males in this group acquiring
                                   HIV. It cannot and must not be missed out!
Royal College of   4 Questions –   Appropriate communication methods are essential in order to reach       Noted.
   Nursing         delivery/mode   this targeted age group in the population. We would expect to see
                                   included in this review, appropriate use of language for young
                                   people and especially when English is not their first language.
Royal College of   Lack of         There is a lack of published qualitative research, which may            NICE considers a wide range of
   Nursing         research        highlight positive outcomes of interventions, which work, therefore     evidence which stretches beyond
                                   the scope, may not get what they are looking for.                       ’published research’ and includes grey
                                                                                                           literature.




                                                                      38
   Stakeholder        Section                              Comments                                                   Response
                      number              Please insert each new comment in a new row.                     Please respond to each comment

Teenage Pregnancy   General     We very much welcome the proposed guidance in helping to                 Thank you. We agree that we should
    Unit, DfES                  strengthen implementation of the Teenage Pregnancy Strategy and          take a broad as view as possible to
                                improvements to young people’s sexual health.                            assess indicators of success and will
                                International research evidence underpinning the Strategy makes          consider all those outcomes that are
                                clear that reducing teenage pregnancy relies on a multi-faceted          reported in the literature.
                                approach, involving a range of partners. Further evidence on the
                                ingredients of effective face to face interventions by health and non-
                                health professionals, will be extremely helpful in the planning and
                                development of integrated targeted support for the most vulnerable
                                groups. However, as teenage pregnancy and poor sexual health
                                result from a complex array of causal factors, evaluation of single
                                interventions can be very challenging. We would therefore                NICE does not currently consult with
                                encourage NICE to take as broad view as possible to assess               end users. However, as part of the
                                indicators of success, rather than rely solely on rates of under 18      fieldwork phase of the guidance
                                conception or STIs as outcome measures.                                  development, we do consult with
                                We would also be keen that the proposed testing of the guidance          frontline workers who have a good
                                with frontline practitioners, also includes testing with young people.   knowledge of users’ views.




                                                                   39
   Stakeholder          Section                              Comments                                                Response
                        number              Please insert each new comment in a new row.                  Please respond to each comment

Teenage Pregnancy   4.2.1         We would recommend including the following within the scope:          Thank you. We expect that all of these
    Unit, DfES                    *Interventions focused on addressing young people’s concerns          interventions will fall within the
                                  about specific contraceptive methods and improving their              parameters of the literature searching
                                  understanding and confidence in method use. For example, it is of     ─ however, it is impossible at this
                                  concern that a significant percentage of teenagers who have           stage to predict what the literature will
                                  received the pill from their GP become pregnant and that              show.
                                  awareness of the full range of methods, including long-acting
                                  contraception remains poor.
                                  *identifying the effective ingredients of successful referral to
                                  contraceptive/sexual health advice services. For example, non-
                                  health professionals such as youth workers, Connexions PAs and
                                  teachers are in touch with young people most at risk and need to
                                  know the most effective ways of referral.
                                  *effective face to face work with under 16s, both on encouraging
                                  delaying early sexual activity and effective contraceptive and
                                  condom use by those who are sexually active. Research evidence
                                  identifies that young people who have sex before 16 are at
                                  significantly higher risk of regret, non-use of contraception and
                                  pregnancy before 18.
                                  *interventions to reduce second unplanned pregnancies after a)
                                  abortion and b) birth.
                                  *interventions with boys and young men about understanding
                                  contraception and sexual health issues and effective condom use.
Teenage Pregnancy   4.4           Please also reflect the Teenage Pregnancy Unit Best Practice          Noted.
    Unit, DfES                    Guidance on the Provision of Effective Contraception and Advice
                                  Services for Young People (2000) which sets out the criteria, based
                                  on research with young people, against which services are
                                  expected to be commissioned.
Teenage Pregnancy   7             Please amend the reference to Guidance for Youth Workers to:          Noted. The scope has been amended.
    Unit, DfES                    Enabling young people to access contraceptive and sexual health
                                  advice: guidance for youth support workers. DfES/Teenage
                                  Pregnancy Unit, 2005.



                                                                    40
    Stakeholder             Section                              Comments                                                Response
                            number              Please insert each new comment in a new row.                  Please respond to each comment

Maranatha               1             There has been a massive increase of sexually transmitted             Thank you. The guidance will be
Community/Council for                 diseases (STIs) in the UK over the past years. Diagnoses of           developed on the basis of the best
Health and Wholeness                  gonorrhoea and chlamydia have all more than doubled between           available evidence. The scale of the
                                      1995 and 2004. Syphilis cases rose by a staggering 1500%. Cases       problem, we agree, is considerable.
                                      of HIV and AIDS are set to rise almost 10 per cent a year and have
                                      more than doubled between 1993 and 2002. There has been a
                                      record numbers of HIV infections in 2001, with 5393 newly
                                      diagnosed cases. This was the highest number of new diagnoses
                                      recorded in a single year since the beginning of the AIDS epidemic.
                                      (Draft NICE guidance; MW Adler, Sexual health – health of the
                                      nation. Sexually Transmitted Infections 2003; 79: 85-87; Written
                                      answer; Sexual Health; Miss Melanie Johnson: Sexually
                                      Transmitted Disease data for England; as at 28 November 2003
Maranatha             2               The number of lifetime sexual partners had increased from 8.6 to      Noted.
Community/Council for                 12.7 for men and from 3.7 to 6.5 for women over the past 10 years.
Health and Wholeness                  Britons also have sex at an earlier age now. For over 55s the
                                      average age of losing their virginity was 19, within the 25-34 age
                                      group it was 16 and among the 16-24 year olds it is only 15. Over
                                      the past 10 years, there has been a “considerably higher rate of
                                      new partner acquisition among those younger than 25 years and
                                      those not cohabiting or married. These strong age effects are
                                      reflected in the substantially higher incidence of STIs in those
                                      younger than 25 years, compared with older people.” (The
                                      Observer, Sex uncovered, result of a poll of 1027 adults aged 16 or
                                      over; 27 October 2002; Johnson AM et al. Sexual behaviour in
                                      Britain: partnerships, practices, and HIV risk behaviours. National
                                      Survey of Sexual Attitudes and Lifestyles; Natsal 2000; Lancet
                                      2001: 358; 1835-42




                                                                        41
    Stakeholder           Section                              Comments                                                  Response
                          number              Please insert each new comment in a new row.                    Please respond to each comment

Maranatha             3             Between 1991 and 2001, attendances at GU (genito-urinary                We agree the problem is
Community/Council for               medicine) clinics in England, Wales & Northern Ireland rose from        considerable. We reserve judgement
Health and Wholeness                669,291 to 1,332,910. In 2004, there were 1.5 million appointments      as to cause and effect until the
                                    at GUM clinics. At the same time, there has been a dramatic             reviews of evidence are complete.
                                    increase in all STIs. The government’s drive to further increase
                                    access to GU clinics will therefore not stop the epidemic of STIs.
                                    (Draft NICE guidance; Sexually Transmitted infections in the UK:
                                    new episodes seen at Genitourinary Medicine Clinics, 1991 – 2001;
                                    Public Health Laboratory)

                                    A small increase in condom use has been observed over the past          If the evidence shows that current
                                    10 years in the National Survey of Sexual Attitudes and Lifestyles.     methods and approaches are
                                    This survey concludes that, due to the increase in risky sexual         ineffective, NICE recommendations
                                    behaviour the ‘benefits of condom use were offset by increases in       will reflect this.
                                    reported partners’. To rely on condoms without emphasis on
                                    reducing casual sex – as the government seems to be doing – will
                                    not stop the epidemic of STIs. (Johnson AM et al.; Natsal 2000;
                                    Lancet 2001: 358; 1835-42. The Medical Institute for Sexual
                                    Health: Sex, condoms and STI’s – what we now know. 2002)
                                    There is a strong positive correlation between increased condom
                                    use at first sexual intercourse and increased teenage pregnancy. If
                                    the traditional approach – to encourage increased uptake of
                                    condoms – were effective, an increased use of condoms would be
                                    associated with a decrease in unwanted pregnancies. However, this
                                    is not the case since condom distribution may be associated with
                                    increased sexual activity and condom use may give a false sense of
                                    security, which increases sexual risk-taking and casual sex. Finally,
                                    condom distribution does not ensure condom use: In a recent
                                    survey, ¾ of male students reported having sex without condom
                                    when they felt one should have been used to protect against
                                    pregnancy or infection. (Williams ES. Contraceptive failure may be
                                    a major factor in teenage pregnancy. British Medical Journal 1995;
                                    311: 806-7. United States Agency for International Development:
                                    The ‘ABCs’ of HIV prevention. ‘ABC’ Expert Technical Meeting
                                    September 17, 2002. Warner L. Condom access does not ensure             The remit of this scope goes beyond
                                                                         42
                                    condom use: you’ve got to be putting me on. Sexually Transmitted        the benefits or otherwise of condom
                                    Infections 2002; 78: 225.)                                              use.
    Stakeholder           Section                              Comments                                                Response
                          number              Please insert each new comment in a new row.                  Please respond to each comment

Maranatha             9             The current UK policy on sexual health is based on the National        Noted.
Community/Council for               Strategy for Sexual Health and HIV, (Department of Health 2001)
Health and Wholeness                and the Teenage Pregnancy Strategy in 1999. The government has
                                    been attempting to tackle high teenage pregnancy rates and
                                    increasing rates of STIs in the UK. The aim is to halve teenage
                                    pregnancy rates by 2010. The Teenage Pregnancy Strategy policy
                                    initiatives are very similar to those introduced by the Conservative
                                    Government in 1992 with the aim of halving the underage
                                    pregnancy rate by the year 2000. The National Strategy for Sexual
                                    Health nor the draft NICED guidance does not promote the only
                                    evidence-based definition of safe sex, which is (apart from
                                    abstinence) mutual monogamy among uninfected partners. The
                                    National Strategy nor the draft NICE guidance does not even
                                    mention the word marriage, even though the majority of the
                                    population – 83% - still considers monogamy and marriage as the
                                    preferred form of relationship. Reduction in casual sex does not
                                    even feature in the National Strategy for sexual health and HIV nor
                                    the draft NICE guidance. These guidance’s are therefore doomed
                                    to fail, since it does not address the underlying problem, the
                                    dramatic increase in casual sex. (In a recent poll 83% of
                                    respondents aged 16 or over believed that monogamy is desirable.
                                    Source: The Observer, Sex uncovered. 27 October 2002; National
                                    Strategy for Sexual Health and HIV, Department of Health, 2001)




                                                                      43
    Stakeholder         Section                                   Comments                                                    Response
                        number                   Please insert each new comment in a new row.                      Please respond to each comment

Maranatha             General         The graph below shows that there has essentially been very little or       To date NICE has not made any
Community/Council for                 no impact of increased access to family planning clinics on                recommendations and will not do so
Health and Wholeness                  underage conceptions. It is of interest to note, that, despite a           until after the consideration of the
                                      massive increase in family planning clinic attendances, underage           evidence.
                                      conceptions have remained unchanged. The previous Conservative
                                      government tried to reduce underage conceptions with the ‘Health
                                      of the Nation’ programme in 1992, which contained very similar
                                      policy measures to the currently adopted teenage pregnancy
                                      strategy. This programme failed to reach its target, to halve teenage
                                      pregnancies by the year 2000. Since this previous programme
                                      failed to significantly reduce teenage pregnancies, it is very likely
                                      that the currently adopted strategy – as recommended by the NICE
                                      guidance - will not make much difference either.

North West Public    4.1 (page 7)     Re: the text, “Activities provided by local health organisations” – this   At the moment NICE intervention
Health Team,                          work will be influencing a wide range of practitioners eg. Local           guidance is primarily for healthcare
Government Office                     authority staff and not just NHS staff. Maybe “health” could be            practitioners, however we
North West                            removed or revised to “health in it’s broadest sense”                      acknowledge that this guidance has
                                                                                                                 relevance to a broad range of other
                                                                                                                 staff and these are outlined in 4.7.
North West Public    4.2, Section 3   National Chlamydia screening upper age limit is 24 not 25                  The NCSP is an opportunistic
Health Team,         (page 9)                                                                                    screening programme targeting
Government Office                                                                                                sexually active young women and
North West                                                                                                       men under 25 years of age. (DH
                                                                                                                 (2004) NSCP in England Programme
                                                                                                                 Overview. P13)




                                                                          44
    Stakeholder       Section                                  Comments                                                    Response
                      number                  Please insert each new comment in a new row.                      Please respond to each comment

North West Public   4.4 (page 10)   The section lists guidance that the scope will reflect which is           Thank you. The scope has been
Health Team,                        welcomed. However, it should also reflect the guidance in “Working        amended to include: ‘Working
Government Office                   Together” when it is published at the end of the year which is a          Together’ when it is available and
North West                          document that aims to provide a sensible and agreed way forward           other DH/TPU guidance.
                                    for a range of agencies and practitioners re: sex and under 13s. In
                                    addition to the TPU/ DH guidance on Sexual Health and Youth
                                    Workers (2001) and Social Care workers (revised in 2004) there is
                                    also TPU guidance on working with Boys and Young Men and
                                    working with BME groups, two groups highlighted in the scope as
                                    being disadvantaged so maybe these pieces of guidance should
                                    also be included?
North West Public   4.5 (page 10)   What is meant by “routine care”? “Interventions will be compared          Although potentially difficult, we want
Health Team,                        against each other” – does that mean the same intervention but            the economic models to compare
Government Office                   conducted by a different practitioner i.e. two GU nurses doing the        interventions that are special or
North West                          same thing with one in one part of the country and one in another.        different, with normal care. We will
                                    Or does it mean comparing the intervention of, for example, a             see how feasible this is as we
                                    young person’s health adviser with the intervention of a GU nurse –       proceed.
                                    or does it mean both?
North West Public   4.6 (page 11)   “Intermediate outcome measures” – while I don’t disagree that             We appreciate that many of the
Health Team,                        measuring intermediate outcomes is important, my concern is that          measures are problematic; however to
Government Office                   for some of the measures, the data doesn’t actually exist so it will      a large extent the outcome measures
North West                          be very difficult to measure distance travelled/ change in behaviour      which are used will reflect those in the
                                    before and after an intervention has taken place.                         literature.
North West Public   4.6 (page 11)   “Primary outcomes” – again, don't disagree with these measures            Please refer to response given above.
Health Team,                        but need to be mindful of the timeliness of the current data that we
Government Office                   have eg. Teenage Conception data is always two years out of date
North West                          so the impact of interventions taking place now in 2005 may not be
                                    realised until 2007/ 08. Some data is collected at the local level in
                                    real time but this may make comparisons between different parts of
                                    the country difficult. At least the advantage of using national data is
                                    it is collected in the same way across the country……




                                                                        45
    Stakeholder       Section                                  Comments                                                  Response
                      number                  Please insert each new comment in a new row.                    Please respond to each comment

North West Public   4.7 (page 11)   Re: who the guidance is aimed at, “The guidance is aimed at             At this stage NICE intervention
Health Team,                        healthcare professionals working in the NHS……..It will also be          guidance is primarily for healthcare
Government Office                   relevant to professionals and lay people……” This contradicts            practitioners, however we
North West                          section 4.1 (3rd paragraph) which states that the focus is on a range   acknowledge that this guidance has
                                    of professionals, not just NHS ones. It also contradicts Professor      relevance to a broad range of other
                                    Kelly’s presentation on 23rd September where he highlighted that        staff and these are outlined in point
                                    the guidance is for non-NHS professionals too. I think we need to       4.7 of the scope.
                                    be explicit that this is going to be guidance for all practitioners,
                                    wherever they are based who undertake one to one interventions.
                                    Otherwise, it just compounds the fact that this is a “NHS” issue and
                                    we know that the
North West Public   4.7 (page 11)   current evidence, especially around Teenage Pregnancy supports a        Noted.
Health Team,        continued       multi-faceted approach by a range of professionals who work with
Government Office                   vulnerable groups to improve their sexual health and well-being.
North West
North West Public   4.7 (page 12)   The second bullet point states “In local authorities it includes:       Thank you. The scope has been
Health Team,                        teenage pregnancy co-ordinators”. Not all Tics are based in Local       amended to include TPCs in
Government Office                   Authorities, some are employed by the NHS and in other                  whichever organisation they are
North West                          organisations, for example, the Connexions service. If this guidance    employed, plus housing support
                                    is aimed at all practitioners who may undertake one to one work         workers and learning mentors.
                                    with young people, the following should also be included: housing
                                    support officers (particularly for those who are supporting young
                                    people making the transition to an independent tenancy of their own
                                    as this is often the point when a young person is most vulnerable)
                                    and learning mentors who should also be included for those local
                                    authorities who still employ them
North West Public   4.11 (page      “Outputs of this work will include…..Information for the general        The final NICE recommendations.
Health Team,        14)             public” - about what? The final NICE recommendations, the
Government Office                   scoping exercise or both?
North West




                                                                       46
    Stakeholder       Section                               Comments                                                     Response
                      number               Please insert each new comment in a new row.                       Please respond to each comment

North West Public   General     Need to be mindful that many non-clinical practitioners eg. Youth           Noted.
Health Team,        comment     workers and teachers operate a policy where they are always
Government Office               accompanied by a co-worker to ensure that they and the young
North West                      person are not in a vulnerable position and so will not actually
                                deliver one-to-one work re: sexual health with young people
North West Public   General     Many young people ring “Sexwise” for information over the phone             Agreed. The scope will be amended
Health Team,        comment     from trained advisers – is this considered to be a one to one               to include helplines, web-based
Government Office               intervention and if so, will this type of intervention be included? In      advice and other ‘remote’ services.
North West                      addition to this, Choosing Health refers to the development of web-
                                based advice for young people re: sexual health so it may be
                                helpful to include any services that are currently offering this facility
                                to ascertain the effectiveness of this approach
North West Public   General     Is there any mileage in the implementation of the final NICE                The implementation of NICE guidance
Health Team,        comment     guidance to be included as a performance indicator eg. Within NHS           in the NHS will be monitored.
Government Office               targets, PSAs or Local Authority Best Value reviews?                        Discussions are currently ongoing at
North West                                                                                                  government-level to determine the
                                                                                                            status of NICE guidance outside of
                                                                                                            the NHS.
North West Public   General     How will the interventions for inclusion in the study be selected?          Clear review parameters will be
Health Team,        comment     How can representative geographical and demographic spread be               agreed at the outset of the work. A
Government Office               ensured?                                                                    range of different study types will be
North West                                                                                                  included in the search. The
                                                                                                            recommendations will be tested
                                                                                                            across a range of geographical sites
                                                                                                            as part of the fieldwork phase of
                                                                                                            guidance development to ensure its
                                                                                                            relevance to local areas.




                                                                     47
    Stakeholder        Section                               Comments                                                     Response
                       number               Please insert each new comment in a new row.                       Please respond to each comment

North West Public    General     In addition to looking at the effectiveness of the intervention, will the   One of the research questions asks
Health Team,         comment     receptiveness of the young person also be looked at? A young                about how effectiveness varies in
Government Office                persons background will affect uptake and compliance following an           relation to age, gender, class and
North West                       intervention i.e. the same intervention undertaken by the same              ethnicity.
                                 practitioner may have a completely different outcome for each
                                 young person who works with the practitioner and this should be
                                 considered
Terrence Higgins     General     THT welcomes the formulation of this guidance as an opportunity to          Thank you.
Trust (THT)                      construct a comprehensive framework to support delivery of sexual
                                 health services. Commitment to an examination of a variety of
                                 types of evidence for interventions that take place in different
                                 settings and which are delivered by a range of service providers is
                                 vital.
Terrence Higgins     4.1         Areas that will be covered                                                  Agreed. The scope has been
Trust (THT)                      Consideration of the impact of interventions on inequalities in             amended to include these categories.
                                 sexual health should be a high priority. In addition to reference to
                                 social class and ethnicity, it may also be useful to examine data on
                                 inequalities relating to sexual orientation and educational
                                 achievement.
  Terrence Higgins   4.2         Interventions                                                               Agreed. Interventions that develop
    Trust (THT)                  Sexual ill health and unwanted pregnancies can often be a                   self-esteem, confidence and
                                 consequence of high-risk behaviours. Such behaviours themselves             negotiation skills are included in this
                                 can often spring from a lack of confidence or self-esteem, or an            scope.
                                 inability to negotiate behaviour within relationships. It is therefore
                                 important to examine evidence for those interventions that seek to
                                 build personal skills in these areas.
                                 Post exposure prophylaxis (PEP)
                                 PEP is a month-long course of anti-HIV medication that since the            We agree. We will examine this issue
                                 mid 1990s has been given to health workers thought to have been             in so far as the literature permits.
                                 at risk of HIV. Some sexual health and accident and emergency
                                 settings are now offering PEP to people who believe they may have
                                 been exposed to HIV. It might therefore be timely to examine the
                                 available data in relation to the targeted use of PEP as a sexual

                                                                      48
Stakeholder   Section                              Comments                                                    Response
              number              Please insert each new comment in a new row.                      Please respond to each comment

                        health intervention.
                        Telephone and email interventions                                         Agreed. The scope has been
                        Increasingly, clients seek advice and support on sexual health and        amended to include telephone help
                        contraception through telephone or internet services, it will therefore   lines and the use of the internet.
                        be important to assess the efficacy of such one-to-one interventions
                        within this guidance.
                        Opportunistic Interventions                                               Agreed
                        The discussion of specific interventions rightly highlights the
                        opportunity for health promotion messages to be communicated
                        during pregnancy testing, termination of pregnancy and antenatal
                        care. Clients who have already presented for treatment or care in
                        such situations are often more receptive to further messages about
                        health, and the connection between treatment, health promotion
                        and avoidance of re-infection is very important. It might therefore be
                        helpful to more explicitly specify the inclusion of opportunistic
                        interventions that can take place in a sexual health screening or
                        treatment setting, either within GUM clinics or in a community or
                        voluntary sector setting.
                        Partner Notification
                        In addition to examining partner notification mechanisms for STIs in      This will be included within the partner
                        general, it would also be useful to examine methods of partner            notification. The scope has been
                        notification that are specific to HIV, as the evidence base for these     amended.
                        may be separate.
                        Service user experience
                        THT strongly supports the commitment within the scope to consider
                        the effectiveness of interventions as perceived by the people to          We agree, and hope that the literature
                        whom they are offered. A qualitative examination of the service           will reflect this.
                        user’s experience is crucial to an assessment of the long-term
                        effectiveness of health promotion interventions.




                                                            49
    Stakeholder      Section                              Comments                                                   Response
                     number              Please insert each new comment in a new row.                     Please respond to each comment

Terrence Higgins   4.3         Interventions that will not be included                                  The guidance will consider the
Trust (THT)                    THT is aware that responsibility for assessing the effectiveness of      prevention interventions which take
                               screening activity currently rests with the National Screening           place within the screening process;
                               Committee. However, within sexual health, screening and health           however it will not consider screening
                               promotion activity are often conducted together and should be            in itself. The scope will be amended to
                               viewed as a holistic package of interventions. In order to allow a       reflect this. We acknowledge this
                               more comprehensive analysis of the effectiveness of both types of        important point.
                               work, it would be helpful to take a more inclusive approach and
                               examine them together. The exclusion of screening for HIV,
                               Hepatitis B and Syphilis is of particular concern, as these infections
                               are targeted within the National Strategy for Sexual Health and HIV.
                               It should also be noted that many clinics commonly offer a range of
                               tests, rather than testing for one infection such as Chlamydia, and
                               this often includes an offer of an HIV test.
                               A comprehensive analysis of interventions in a range of settings
                               would be helpful, and the exclusion of sexual health screens in GU
                               departments may lead to certain key health promotion interventions
                               being omitted from this guidance. If it is not possible to include
                               such interventions in this assessment, inclusion in a later set of
                               accompanying guidance would be helpful.
                                Although PSE and group based interventions will not be covered in       PSE will not be covered in this
                               this guidance, it will be essential to examine interventions such as     guidance. There is the facility on the
                               the teaching of PSE as a school subject and group interventions          NICE website to suggest topics for
                               within African communities.                                              consideration for our future guidance
                                                                                                        at:
                                                                                                        www.nice.org.uk/page.aspx?o=topics
                                                                                                        uggest We would expect that at some
                                                                                                        point in the future NICE will be asked
                                                                                                        to look at these issues.




                                                                  50
 Stakeholder         Section                              Comments                                                  Response
                     number              Please insert each new comment in a new row.                    Please respond to each comment

Terrence Higgins   4.4         Populations                                                             Agreed. The scope will be amended
  Trust (THT)                  In addition to referring to Department of Health guidance for           to include ‘Working Together’ when it
                               clinicians on the provision of sexual health advice and treatment to    is available.
                               young people, it is also essential that NICE guidance reflects
                               current protocols regarding the safeguarding of children stemming
                               from the Department for Education and Skills. For example, current
                               consultation on the guidelines, “Working together to safeguard
                               Children” will have implications for professionals working with young
                               people and advising them on sexual health and contraception.
Terrence Higgins   4.5         Comparators                                                             Although potentially difficult to do, we
  Trust (THT)                  The scope currently indicates that interventions will be compared       want the economic models to
                               “against each other and against routine care” where the data are        compare interventions that are special
                               available. Obviously, benchmarking will be an important part of the     or different with normal care. We will
                               assessment, but further clarity around how “routine care” might be      see how feasible this is as we
                               defined would be welcomed.                                              proceed.
Terrence Higgins   4.6         Outcome Measures                                                        Agreed, however to a large extent the
  Trust (THT)                  If possible, when examining the outcome measures related to             outcome measures which are used
                               partner notification programmes, it will be useful to assess the        will reflect those in the literature.
                               number of contacts who later present for care themselves and of
                               these people, those who had undiagnosed infections for which they
                               were appropriately treated. A more specific reference to a reduction
                               in the prevalence of HIV would also be helpful within the outcomes
Terrence Higgins   4.7         Target Audience                                                         Agreed. The scope has been
  Trust (THT)                  It is welcome that the target audience for this guidance is             amended to reflect the range of client
                               acknowledged as being broader than NHS staff and providers.             groups the voluntary sector works
                               However, the section referring to staff within the voluntary sector     with.
                               only specifically refers to those developing or delivering sexual
                               health services for young people. Professionals within the voluntary
                               sector work with a range of client groups, including all of the
                               vulnerable groups listed as target populations for these assessed
                               interventions. A more explicit reference to this range of client
                               groups would ensure that all practitioners use this guidance where
                               relevant to their work.

                                                                  51
 Stakeholder         Section                              Comments                                                 Response
                     number              Please insert each new comment in a new row.                   Please respond to each comment

Terrence Higgins   4.10        Evidence for Consideration                                             Noted.
  Trust (THT)                  THT strongly welcomes the high level of stakeholder involvement in
                               the formulation of this guidance, and the opportunity for
                               stakeholders to feed in other evidence, including “grey literature”
                               during the development process. Given the difficulties sometimes
                               associated with gathering hard data on public health and health
                               promotion interventions, an examination of a variety of types of
                               evidence, beyond that normally found in scientific journals, will be
                               essential.




                                                                  52
     Stakeholder      Section                              Comments                                                    Response
                      number              Please insert each new comment in a new row.                      Please respond to each comment

Love for Life       General     STI reduction will only be achieved with a holistic approach that         Noted. We will look at the full range of
                                includes at least promoting equally actively through policy, strategy     evidence before making
                                and grass root patient contact the delay of first sex, the reduction of   recommendations, including evidence
                                casual sex and increased condom usage.                                    relating to abstinence and delay of
                                                                                                          first sex.
                                The risk is that health documents are almost entirely focused only
                                on services provision with little emphasis on how through the public
                                health medium and in the one to one consultation delaying first sex
                                and the reduction of partners can be promoted.

                                Unless we adequately address this deficiency future National
                                Survey of Sexual Attitudes and Lifestyles reports will only show
                                further lowering of age of first coitus and increased average number
                                of partners. Inevitably more service provision will be necessary as
                                sexual behaviours move increasingly to earlier coitus and more
                                partners.

                                How often in a family planning or STI consultation does the               This is an empirical question. If the
                                practitioner suggest that the patient should seriously consider not       literature provides evidence, then
                                having a concurrent partner or even that they might want to               NICE will make the appropriate
                                consider not changing sexual partners or not becoming sexually            recommendation.
                                active at all or later in a subsequent relationship?
                                This same behavioural approach is often used within health
                                promotional messages in a consultation around alcohol or drugs.

   Women’s Health   Guidance    The title seems to emphasise screening for Chlamydia, rather than         The words used in the title were those
                    Title       suggesting a wide range of face to face or 1 to 1 interventions and       used by the DH in its referral.
                                including a range of sexually transmitted infections.
                                We find the short title very appropriate.




                                                                    53
    Stakeholder      Section                                   Comments                                                   Response
                     number                   Please insert each new comment in a new row.                     Please respond to each comment

Women’s Health    Background        Although we recognise that this draft is dealing only with               We agree that tackling teenage
                                    interventions and not a wider programme, it is our experience that       pregnancy and STIs including HIV is
                                    young people often do not reach the stage of having a 1:1                wider than a health service issue.
                                    intervention until after being exposed to sexually transmitted           Your point is important and will be
                                    infections or potential pregnancy.                                       discussed when recommendations
                                                                                                             are being developed.
                                    This is perhaps particularly true of interventions in health settings,
                                    which are a major focus of this guidance. We hope that NICE will in      We recognise the range of
                                    future look at a wider programme to include social, educational,         interventions that could be
                                    financial, housing, cultural, press & media, advertising, new            considered. There is the facility on the
                                    technology and the broad range of issues that can impact on young        NICE website to suggest topics for
                                    people’s health and well-being. We recognise that this is wider than     consideration for our future guidance
                                    a health service issue, and that targets such as ‘to reduce the rate     at:
                                    of under eighteen conceptions by 50% by 2010’ may be                     www.nice.org.uk/page.aspx?o=topics
                                    unachievable by health and education services alone.                     uggest We would expect that at some
                                                                                                             point in the future NICE will be asked
                                                                                                             to look at these issues.
Women’s Health    Inequalities in   In addition to those groups mentioned, young people with                 The scope includes the whole
                  sexual health     disabilities, such as learning difficulties, may be particularly         population.
                                    unaware of risks and less able to protect themselves against risk.




                                                                        54
    Stakeholder      Section                                  Comments                                                     Response
                     number                  Please insert each new comment in a new row.                       Please respond to each comment

Women’s Health    Interventions   The interventions mentioned do not specifically include telephone           Agreed. Telephone helplines, email
                                  helplines, e-mail or text services. As a health information service,        and Internet services have been
                                  we receive enquiries and requests for sexual health information             added to the scope as one-to-one
                                  from young people aged 11 years upwards. Many young people                  interventions to be considered.
                                  find it easier to raise sexual health issues anonymously and may
                                  prefer these types of interventions.
                                  We realise that gathering the evidence for these types of
                                  interventions is likely to be a challenge.                                  One-to-one peer-led interventions are
                                  We also wonder whether peer interventions, such as by peer                  included in the scope.
                                  mentors in schools or youth groups will be considered.
                                  It would be good to consider interventions that deliver information in      Agreed.
                                  a range of formats, including those appropriate for people with
                                  disabilities (verbal, written, visual, tape, different languages).
Women’s Health    Populations     We would also like to see some reference to young people with               The scope includes the whole
                                  disabilities, including learning difficulties. We also feel that boys, in   population. Boys will be one of the
                                  particular, may be harder to reach, as they may be less likely to           groups to whom particular reference
                                  access health services and feel less personally affected by sexual          will be given.
                                  health issues.
Women’s Health    Target          As well as those mentioned, we feel the guidance may also be                NICE guidance is produced primarily
                  audience        appropriate for faith and cultural groups (some these may be                for the NHS, although our guidance
                                  voluntary sector groups, others may not). Faith leaders and youth           will be relevant to others, including
                                  workers within faith communities can have a strong influence, in            faith and cultural groups.
                                  many different ways, on the young people they meet.




                                                                       55
    Stakeholder         Section                              Comments                                                  Response
                        number              Please insert each new comment in a new row.                    Please respond to each comment

Leicestershire AIDS   General        1) There is a need to ensure that interventions designed to          Noted.
Support Services                         meet targets to reduce the rate of under 18 conceptions do
(LASS)                                   not in practise run counter to the aim of reducing STI’s.
                                     2) We have concerns about the use of depo-proverea and
                                         promotion of early abortions.
                                     i)      People may have more unprotected sex assuming that
                                             they will not get pregnant hence higher risks of STI’s
                                     ii)     Health concerns: bone problems, lack of
                                             awareness/concern about STI’s, increased risk taking.
                                     3) We are concerned that the focus on teenage conceptions
                                         targets young girls – boys should be taught about
                                         consequences with equal emphasis
                                     4) The National Strategy for HIV and Sexual Health does not
                                         seem to have the involvement Govt Depts other than the
                                         DoH. As a result there are conflicting Social Policies ( e.g.
                                         some people not receiving free treatment for HIV)
                                     5) Prejudice and stigma re HIV must be addressed as a high
                                         priority.
                                     6) ‘Initiatives’ would be more effective if they were long-term
                                         (e.g. 10 years plus strategies for genuine social change) and
                                         also different Govt Depts ‘bought in’ to them and acted in
                                         accord (e.g. Education linking up with Health re meaningful
                                         education for young people; using methods which
                                         demonstrably engage them (e.g. Theatre in Education) re
                                         STI’s and HIV. Short-term ‘leaflets and campaigns’ will not
                                         create long-term change in a highly sexualised culture

                                  SOME INITIAL GENERAL
                                  THOUGHTS/COMMENTS/OBSERVATIONS:

                                  The aim of “reducing rate of under 18 conceptions” could be at odds
                                  and a contradiction with the other aim of “reducing Sexually
                                  Transmitted Infections” as conceptions could be reduced by a
                                  concerted campaign to, for example, prescribe the oral
                                  contraceptive pill; or injectable contraception like Depo-Provera; or
                                                                       56
                                  using emergency hormonal contraception or IUD; or even by
                                  promoting early abortions (even in young girls who have already
                                  had one or more before – as I have recently heard from one locality
   Stakeholder            Section                               Comments                                                       Response
                          number               Please insert each new comment in a new row.                         Please respond to each comment

Department of Health   Trends       May also be Explained by a whole range of other factors not                   Noted.
                                    mentioned here
Department of Health   4.2.9        [There are no QALYs for sexual health, except HIV where death is              Noted. We will take this into
                                    the endpoint. And specific to chlamydia, no one has quantified the            consideration when designing the
                                    quality of life costs of infection, treated infection, multiple infections,   economic evaluation.
                                    or undiagnosed/untreated infection(s). this will be a very difficult
                                    standard for cost-effectiveness research on STIs. Economic
                                    modelling using transmission dynamic models has been the next
                                    best tool we have to assess the impact of interventions for STIs.
                                    Note recent paper by Turner KME, et al. (2005) and forthcoming
                                    paper by our team here.]
Department of Health   Appendix 1   [again, are we talking preventing incidence cases or reducing                 We will consider both of these.
                                    prevalence in the population or both
Department of Health   Appendix 2   :[but these data only cover populations that seek services at GUM             Noted.
                                    clinics. If the intervention is not aimed to this population, this may
                                    not be the best data source to use to assess the intervention’s
                                    success.]
Department of Health   General      There is also an age limit for the NCSP and we would prefer that we           We will address all of the areas within
                                    all play to the same level and look at under 25's for everything.             the scope as far as the evidence
                                    Our final concern is that it is too focussed on STI's & HIV and the           allows and will not focus more on
                                    contraceptive / abortion side is missed.                                      some areas than others.

                                    One further issue that CAG need point out, is that the NCSP is not            We will consider evidence from
                                    due for full implementation until 2007, so chlamydia screening in all         outside of the NCSP.
                                    venues and by all providers, either within or outside the NCSP
                                    should be included; also that since this covers only 1 to 1                   We will consider one-to-one Internet
                                    interventions, many self-initiated elements of the NCSP such as               interventions, but not mass media
                                    responding to pee in the pot interventions linked to internet or              interventions.
                                    poster campaigns are not covered.




                                                                          57
   Stakeholder            Section                                  Comments                                                    Response
                          number                  Please insert each new comment in a new row.                      Please respond to each comment

Department of Health   4.1 Areas that   We would be grateful if you could consider including the private          We will not be considering mass
                       will be          sector as well as statutory & voluntary, for instance through social      interventions such as social
                       covered          marketing. This would include pharmacies and condom                       marketing, however the scope does
                                        manufacturers.                                                            include the private sector.
Department of Health   4.2              Under the contraceptive service element you may wish to consider:         Agreed. The scope has been
                       Interventions          Accessibility and acceptability                                    amended to reflect this.
                                        Where and when interventions are made, for example post abortion
                                        (which needs to include the option of a complete range of
                                        contraception not just advice)
Department of Health   4.4              Would you please consider what PCTs should commission, which              The brief from the DH for this project
                       Populations      in turn would then permit the role of group based interventions to be     was very broad. Time and resource
                                        considered. For instance, the addition of an outreach worker to a         constraints meant that the work had to
                                        sexual health service can make a significant difference in raising it’s   be made manageable by some
                                        profile, and therefore the uptake of that service. It is recognised       means. NICE decided in this instance
                                        though that it is beyond the NICE scope to comment in any depth           that focusing on one–to-one
                                        on the most effective content for any group interventions beyond          interventions made this work
                                        some basic possible functions. As far as DH is aware, the original        manageable. We would expect that at
                                        brief did not limit this to one to one interventions, so expanding it     some point in the future NICE will be
                                        would be helpful.                                                         asked to look further at sexual health
                                                                                                                  issues.
Department of Health   4.6 Outcome      Could you please consider mentioning the uptake of services, for          We will consider the widest range of
                       measures         instance, which demonstrates some excellent and accessible                outcome measures possible, though
                                        services that are working in areas with (currently) less than             the measures used will, to a large
                                        satisfactory outcomes.                                                    extent, depend on the literature.
Department of Health   4.7 Target       Could school nurses be included here?                                     School nurses are included in section
                       Audience                                                                                   4.7




                                                                            58
   Stakeholder           Section                                  Comments                                                Response
                         number                  Please insert each new comment in a new row.                  Please respond to each comment

Department of Health   4.8 Research    Would you please consider amending the “one to one” question, to      The brief from the DH for this project
                       questions       read: ‘What interventions should be commissioned to contribute to     was very broad. Time and resource
                                       the reduction of STIs and unintended teenage conceptions?’            constraints meant that the work had to
                                                                                                             be made manageable by some
                                                                                                             means. NICE decided in this instance
                                                                                                             that focusing on one-to-one
                                                                                                             interventions made this work
                                                                                                             manageable.
Department of Health   4.10 Evidence   We would be grateful if you could consider referring to the           Agreed. The scope has been
                       for             Department of Health’s Policy Research Programme’s allocation of      amended to include consideration of
                       consideration   £1 million annually to the Medical Research Council , for research    the MRC research on sexual health
                                       on sexual health and HIV, to support implementation of the National   and HIV.
                                       Strategy for Sexual Health and HIV and to develop the longer term
                                       evidence base. This programme of research is managed on DH’s
                                       behalf by the MRC, and advised the Sexual Health and HIV
                                       Research Strategy Committee (SHHRSC).
                                       DH is keen to ensure that research output from this programme
                                       feeds into the development of NICE guidance in this area.
                                       The MRC will be collating comments from Members of the
                                       SHHRSC on the draft scope, and submitting these separately to
                                       NICE.
 National Pharmacy     General         The National Pharmacy Association welcomes NICE’s intention to        Thank you.
  Association Ltd                      produce public health intervention guidance on preventing sexually
                                       transmitted infections and reducing under 18 conceptions. We
                                       believe the proposed scope is generally well defined.
 National Pharmacy     Section 4.1     We are pleased that NICE will focus not only on the effectiveness     Agreed.
  Association Ltd                      and cost effectiveness of interventions, but also investigate their
                                       impact on health inequalities. The Department of Health (DH) has
                                       acknowledged pharmacists as “probably the biggest untapped
                                       resource for health improvement.” (A Vision for Pharmacy in the
                                       New NHS, DH, July 2003).




                                                                         59
    Stakeholder        Section                                Comments                                                   Response
                       number                Please insert each new comment in a new row.                     Please respond to each comment

 National Pharmacy   Section 4.2   This section lists opportunities to provide advice about prevention of   Noted.
  Association Ltd                  under-18 conception and sexually transmitted infection (STI). The
                                   point of supply of contraceptive medication/devices provides a
                                   platform for providing advice and might usefully be added to your
                                   list. In the case of Emergency Hormonal Contraception (EHC), it is
                                   a licence requirement that a pharmacist consultation is undertaken
                                   with the client at the point of over-the-counter supply. Choosing
                                   Health Through Pharmacy: A programme for pharmaceutical public
                                   health 2005-2015, DH 2005, p75) refers to a “strong evidence base”
                                   for expanding pharmacists’ EHC supply service into “services for
                                   the under 16s and into sexual health advice generally”.                  Thank you.

                                   The new, national community pharmacy contract framework –
                                   operational since April 2005 – provides a framework for advice,
                                   signposting and health promotion in all community pharmacies.
                                   Details are available at www.psnc.org.uk .
National Pharmacy    Section 4.7   Appendix A’s list of primary healthcare professionals working in the     Noted. The scope has been amended.
Association Ltd                    NHS includes GPs and practice nurses, as well as pharmacists.
                                   Pharmacists are listed later as “private sector interested parties”,
                                   which we take to be a reference to community pharmacists. In fact,
                                   community pharmacists are acknowledged by DH both as
                                   healthcare professionals (formally in DH guidance on the 24 hour
                                   access to healthcare professionals target) and as an “integral part
                                   of the NHS family” (A Vision for Pharmacy in the New NHS, DH,
                                   2003, p7). Community pharmacists should be re-categorised
                                   accordingly.




                                                                      60
    Stakeholder        Section                                   Comments                                                    Response
                       number                   Please insert each new comment in a new row.                      Please respond to each comment

National Pharmacy   Section 4.8       We believe that your list of research questions is comprehensive.         Noted.
Association Ltd                       In particular, we are pleased that “setting/site of delivery” is
                                      included, because accessibility of sexual health interventions is a
                                      crucial ingredient in interventions’ effectiveness. Tackling Health
                                      Inequalities: A programme for action (DH, 2003, p32) highlights the
                                      importance of community settings, including community
                                      pharmacies, in facilitating early detection and treatment in the public
                                      health context. Choosing Health: Making healthy choices easier
                                      (DH, 2004, p146) envisages testing and screening for STIs
                                      increasingly being delivered in the community, citing community
                                      pharmacies as a “building block” for this expansion.

                                      Your researchers should, in our view, consider accessibility in terms     Agreed.
                                      of opening hours and promptness of service as well as
                                      geographical vicinity.
MRC                 Section 3 -       Although the reported numbers of new diagnoses of gonorrhoea              Noted.
                    The need for      and first episode genital herpes (FEGH) from GUM clinics
                    guidance          decreased between 2003-4, this observation may have been
                                      affected by deteriorating access to clinic services. Both gonorrhoea
                                      in men and FEGH in both sexes often cause severe acute
                                      symptoms. If patients were unable to access GUM care, they may
                                      have sought treatment elsewhere. Cases diagnosed in other
                                      locations are unlikely to have been reported and to appear in HPA
                                      statistics.
MRC                 Section 4.1 -     The scope of the intervention guidance concerns one-to-one sexual         Agreed.
                    Areas that will   health interventions.
                    be covered




                                                                          61
  Stakeholder      Section                                 Comments                                                    Response
                   number                 Please insert each new comment in a new row.                      Please respond to each comment

MRC             Section 4.2 -   In addition to the interventions outlined, the scope should also          Interventions delivered to prevent re-
                Interventions   include the prevention of further acquisition of infection (and           infection will be included.
                                unwanted conception) in those who have presented for care. The
                                so-called treatment / prevention synergy is important because
                                individuals who have presented with either symptomatic conditions
                                or who, although asymptomatic, perceive themselves at risk of
                                such, are sensitised to health education messages and future risk-
                                reduction.


                                Thus, services for treatment and care have a vital role in one-to-one
                                interventions to help prevent further sexual health problems in
                                individual patients.

                                Partner notification for STIs may take place in a variety of settings,    We will consider evidence for PN from
                                and be performed by a variety of healthcare professionals. It will be     any setting. If the literature highlights
                                helpful to compare outcomes from traditional GUM clinic-based PN          differences between settings then
                                endeavours with those from PN conducted in primary care and               these will be reported.
                                other community-based settings.

                                Within GUM clinics up to half of all presenting patients are              The DH referral asks us to look at
                                asymptomatic and present for screening. In the draft scope, a             chlamydia screening specifically, and
                                differentiation is made between Chlamydia screening in GUM and            we will do this across both GU and
                                non-GUM settings. Where an individual presents for screening may          non-GU settings, however general
                                not be necessarily indicate different levels of risk. Is it then          screening issues are the remit of the
                                reasonable to exclude screening for chlamydia and other STIs in           National Screening Committee.
                                GUM clinic attenders?
                                In many settings, including GUM, screening is performed for a             Noted.
                                range of STIs rather than just for a single infection such as
                                chlamydia. This includes the routine offer of testing for HIV, which is
                                potentially the most serious STI.




                                                                    62
  Stakeholder      Section                                  Comments                                                   Response
                   number                  Please insert each new comment in a new row.                     Please respond to each comment

MRC             Section 4.3 -    The draft scope states that Standard sexual health screening in GU       We will consider health promotion
                Interventions    departments will not be covered. The reason for this exclusion is        interventions delivered at any point
                which will not   not clear, nor does it explain this refers to. Do the drafters mean to   whether as part of general screening,
                be included      exclude standard STI testing of symptomatic patients? As explained       or testing. We will not, however,
                                 above, the inclusion of outcomes from GUM clinic interventions has       consider screening (other than for
                                 considerable importance in providing comparator data with hard           chlamydia) or testing as clinical
                                 outcome measures for prevention of reinfections and the efficacy of      interventions as they are outside the
                                 partner notification. It also excludes screening for HIV infection,      remit of this guidance.
                                 syphilis, and hepatitis B which are potentially serious STIs. The
                                 national strategy contained targets for reducing the incidence of HIV
                                 and for uptake of hepatitis B immunisation in men who have sex
                                 with men. Hard outcome data for these endeavours exists.
MRC             Section 4.5 -    The document states that interventions will be compared …against         Although potentially difficult to do, we
                Comparators      routine care. What is the definition of routine care in the context of   want the economic models to
                                 screening? It would be helpful to have this clarified.                   compare interventions that are special
                                                                                                          or different with normal care. We will
                                                                                                          see how feasible this is as we
                                                                                                          proceed.




                                                                    63
  Stakeholder      Section                                 Comments                                                   Response
                   number                 Please insert each new comment in a new row.                     Please respond to each comment

MRC             Section 4.6 –   Some of the intermediate outcome measures are rather soft and            NICE consider the broadest possible
                Outcome         place a high reliance upon self-reported data, that may correlate        range of outcome measures, both
                measures        poorly with actual behaviour. In PN outcomes, it is important to         hard and soft. However, the outcome
                                determine not only the number of contacts identified/notified, but       measures we can report on will reflect
                                also the numbers of these contacts who present for care, who are         those used in the literature reviewed.
                                found to have undiagnosed infections, and who receive appropriate
                                treatment. The primary outcome measures include: reduction in the
                                rates of STIs and unintended pregnancy rates. HIV incidence and          HIV to be included.
                                prevalence are also important, as is HIV testing uptake.
                                It will be important to define within the scope which specific STIs
                                are being considered. In addition to uncomplicated bacterial STIs,
                                and first episodes of genital warts or genital herpes, complications
                                such as PID and epididymitis may need to be considered. HIV              We agree that these are important,
                                should definitely be included. However, syphilis is also too serious a   however, this scope will not be
                                health problem to be excluded. Diagnosis is of itself an outcome of      considering treatment and care.
                                limited value to an individual unless it is followed by appropriate
                                treatment and care. The timeliness of treatment following
                                presentation and diagnosis is also highly relevant.
MRC             General         From experience of working in this area, it is very, very ambitious to   We agree that this is very challenging,
                                ask for evidence on all one-to-one interventions that might reduce       and we will be reliant on the outcome
                                STIs and unintended teenage pregnancies, as well as producing            measures reported in the literature.
                                QALY gain estimates and some measure of inequality reduction,
                                the latter of which is entirely novel.




                                                                   64
  Stakeholder     Section                              Comments                                                Response
                  number              Please insert each new comment in a new row.                  Please respond to each comment

MRC             General     There is a worry about the reductionism of the NICE Reference         Where the use of QALYS is not
                            Case for many interventions, but especially for public health         practicable or possible, we will
                            interventions, and even more so for 'difficult' areas within public   attempt to use other forms of
                            health, such as reducing teenage pregnancy. 'Normally', QALYs as      economic evaluation. Your
                            a measure of benefit might be quite controversial because they do     observation is helpful and will be
                            not cover all aspects of benefit; however, a case can at least be     discussed with the health economists
                            made for computing results based on the NICE Ref Case (with           at NICE.
                            QALYs as the main outcome/benefit measure) and building in
                            'broader concerns' around that. However, in the example of teenage
                            pregnancy reduction the main outcome itself (ie reduced
                            unintended pregnancies) cannot even be expressed in QALY terms;
                            it may be possible to express in QALY terms the various
                            complications or medical conditions averted by reducing such
                            pregnancies, but this will be only a very small part of the overall
                            picture of gains in well-being brought about.




                                                              65
      Stakeholder     Section                              Comments                                                   Response
                      number              Please insert each new comment in a new row.                     Please respond to each comment

MRC                 General     Related to the concerns expressed in 2), there was a meeting at          Noted.
                                NICE (in May?) which was about how to conduct economic
                                evaluations as part of the NICE HTA process now that public health
                                was being brought under the NICE remit. There was no particular
                                consensus on how to do this but a lot of concern was expressed
                                about 'shoehorning' evaluations of public health interventions into
                                the pre-existing NICE framework which the Reference Case is
                                largely representative of. This needs very careful consideration
                                here; a common alternative (proposed at the meeting referred to)
                                was simply to have all resource impacts (costs and cost savings)
                                expressed separately (and also netted out) on the cost side and to
                                have all impacts on well-being listed on the benefit side, and using
                                such a 'balance sheet' to aid a recommendation as to what to do.
                                Many would contend that such a 'balance sheet' approach would be
                                more reasonable than reducing everything to one number which
                                'gives an answer' This is a very worthwhile project, which will
                                highlight where there are current deficiencies in available evidence
                                and help inform future research calls for submissions to the MRC
                                SHHRSC. It is also to be hoped that it may ultimately lead to the
                                development of a Public Health Programme in Sexual Health                Thank you.
HPA                 4.6         One of the primary outcomes described is a reduction in the rate of      The outcomes will be defined by the
                                STIs but there should perhaps be some clarification of how this will     studies reviewed, and the data and
                                be defined and what data will be used to assess this. Are routinely      measures of change which are used
                                collected national surveillance data to be used or will data be          in those studies will be considered.
                                collected specifically at the local level? Data on STIs are only
                                routinely collected at the national level from GUM clinics. For
                                Chlamydia in particular, the rate of diagnosis in GUM clinics is not a
                                good marker of infection incidence, since many individuals may be
                                diagnosed outside GUM clinics, and many will not be diagnosed at
                                all. Much of the large rise in Chlamydia diagnoses in recent years
                                will have resulted from more asymptomatic people being tested.
                                Chlamydia prevalence would be a better measure of control of this
                                infection.


                                                                    66
       Stakeholder     Section                                  Comments                                                  Response
                       number                  Please insert each new comment in a new row.                    Please respond to each comment

LIFE                 General         LIFE’s caring services exist to offer free pregnancy testing and non-   Noted.
                                     directional counselling to women who find themselves unexpectedly
                                     pregnant, as well as those struggling with pregnancy loss or
                                     suffering psychological trauma from previous abortion experiences.
                                     We also offer practical and financial support to women facing crisis
                                     pregnancies or struggling to raise young children. Through our
                                     housing programme we provide supported accommodation to
                                     women made homeless by pregnancy. This has enabled us to grow
                                     , through experience, in knowledge of the reasons for what many
                                     prematurely engage in sexual activity and the health effects of this
                                     behaviour. As a charity we take pride in our Educational and caring
                                     services which are geared towards reducing sexually transmitted
                                     infections and under 18 conceptions. Our work in these sectors has
                                     grown to meet demand in recent years for holistic and wholesome
                                     sex and relationships education (SRE) This particular submission
                                     will give LIFE’s proposals for how people involved in delivering one-
                                     to-one sexual health interventions should advise or inform whose
                                     who are accessing the service. Our recommendations are based
                                     upon our own experiences from working in the relevant filed which       Thank you.
                                     we trust will be if benefit to NICE, the government and wider
                                     society.
LIFE                 Contraceptive   Advice on contraception should be veracious if it is to accord with     Thank you. The guidance will be
                     advice          good practice and be truly beneficial to young people. We agree         developed on the basis of the best
                                     with the statement in Appendix A 4.2 that information provided          available evidence that most
                                     should be “basic, accurate and unambiguous” (Ellis and Grey,            effectively answers the questions,
                                     2004).                                                                  rather than relying on a predetermined
                                     With reference to published material from government sponosr4ed         view of what is available.
                                     bodies and the contact of previous NHS campaigns Life believes
                                     that young people have been misled and misinformed on several
                                     specific issues.
                                     1) When one offer information and advice on sexually transmitted        Noted.
                                     infections (STI’s), making generalisations in inaccurate and
                                     irresponsible. An important fact to iterate is that STI’s can be


                                                                        67
Stakeholder   Section                              Comments                                                   Response
              number              Please insert each new comment in a new row.                     Please respond to each comment

                        contracted in different ways. For example, HIV can only be passed
                        on via blood, semen and vaginal fluids, where as genital warts
                        (Human Virus) can be contracted via skin-on skin contact. This is a
                        crucially important point to make because young people are
                        frequently being given the false impression that using a condom
                        and practising ‘safer sex’ will protect them from the infections.
                        Currently the NHS website (www. playingsafely.co.uk) mentions the
                        above fact in small print, however, the prominent banner which
                        reads “Its your future. Use a condom” has the effect of seriously
                        misleading young people. WE suggest that in one-to one advice
                        that is given to young people it should be stressed that using a
                        condom will not offer protection against STI’s passed on via skin-       Thank you for this point.
                        on-skin contact (e.g. Genital warts & Genital herpes). Of a patient is
                        not made consciously aware of this fact then they are putting their
                        own health and the health of others at serious risk.
                        2)Many young people are routinely misinformed about emergency
                        hormonal contraception (EHC).While there may have been a
                        change of opinion with regard to the beginning of human life in this
                        country, many people still hold fast to the principle that human life
                        begins at fertilisation (conception). Forms of EHC such as Levonelle
                        (morning after pill) are marketed as ‘emergency hormonal
                        contraception’ when in fact the drugs can have the effect if causing
                        a spontaneous early abortion through ejecting a fertilised ovum
                        from the mother’s womb. It should be incumbent upon those who
                        deliver one-to-one interventions that they describe how EHC
                        actually works and that an embryo, if conceived, will be discarded
                        as a result of taking the drug. We treat thousands of women every
                        year who suffer from psychological illness because of a previous
                        abortion. Many are affected once they face fertility problems
                        because they realise that their past conceptions would now be
                        welcome and are regrettably irretrievable. It is irresponsible to
                        withhold or under-emphasise exactly what taking emergency                Noted.
                        hormonal contraception (EH) entails. We stress, information should


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Stakeholder   Section                               Comments                                                    Response
              number               Please insert each new comment in a new row.                      Please respond to each comment

                        be basic, accurate and unambiguous
                        3) We are actively assisting young people in the free service that
                        we provide for the. Our comprehensive support programme of
                        pregnancy testing, counselling, supported accommodation, free
                        baby clothes and equipment is fee of charge for all to access. If
                        young people are made aware of practical alternatives to abortion
                        and the fact that they will receive, free of charge, physical, practical
                        and emotional support, they are less likely to feel pressured into
                        having an abortion as’ their only choice’. They will be given greater
                        time and opportunity to make a choice they can live with. If one is
                        aware of free and accessible alternatives to abortion the will not feel
                        coerced into making a rushed decision and thus putting their
                        psychological health at risk. This will be of benefit to young people
                        putting people as they will not feel coerced into a decision they are
                        uncomfortable with. This is also the case with regard to prenatal
                        screening: young people should be provided with information about
                        our ‘Zoe’s Place’ baby hospices, which provide 24 hour palliative
                        and respite care to babies with severe disabilities that are routinely
                        diagnosed via screening in utero. We would suggest that hose
                        delivering one-to-one intervention (particularly a pregnancy testing
                        service) make young men and women aware of the service that                Noted.
                        LIFE provides as a priority to achieving optimum standards of
                        healthcare.




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    Stakeholder           Section                              Comments                                                  Response
                          number              Please insert each new comment in a new row.                    Please respond to each comment

 National Chlamydia     General     I am concerned that there is the age range for unintended               Our aim is to consider all elements of
Screening Programme                 conceptions but not for the STI’s. Lastly, with my Faculty Family       the scope and we will not privilege
                                    Planning hat on, I would like assurance that this document will not     any particular section of it.
                                    become just STI’s & HIV with the contraceptive bit minimal. It would
                                    help in the document if STI’s were not always mentioned first.
                                    Afterall, c for conceptions comes before S for STI or H for HIV
Genito Urinary Nurses   General      The document does not appear to consider confounding                  Confounding variables and links will
     Association                        variables associated with risky sexual behaviour such as the        be considered as they arise in the
                                        use of alcohol and/or drugs                                         literature reviewed.
                                     The link between acquiring an STI and the increased risk of
                                        acquiring HIV.
                                     The link between unintended pregnancy and the increased risk
                                        of acquiring an STI including Chlamydia.
                                     The significant interventions that occur in G U Medicine (GUM)        Interventions in GU will be included.
                                        departments, in terms of advice about the use of condoms,
                                        prevention of acquiring STIs, prevention of conception and the
                                        public health issues related to partner notification, which are
                                        initiated and undertaken by health care professionals in GUM
                                        often when an individual attends the department/s for either a
                                        standard STI screen or screening for HIV and/or hepatitis B.
                                     During the consultation a sexual history (SH) is taken, one of
                                        the rationales behind taking an in depth SH is to identify high
                                        risk sexual behaviour, then to either offer an intervention or to
                                        refer to another HCP to develop strategies to reduce the risk of
                                        the acquisition of STIs and HIV.
                                    
                                    Finally there were 1.5 million appointments made in GUM                 The interventions given at the time of
                                    departments in England during 2004, a significant number of these       screening or testing will be
                                    attendances will have been for standard STI screens, which is to be     considered. It is only the screen/test
                                    encouraged, which include the screening for HIV, syphilis and if        itself which will not.
                                    appropriate Hepatitis B. We believe it will be extremely short
                                    sighted to exclude the many interventions undertaken to decrease
                                    the incidence of STIs during these consultations

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 Stakeholder        Section                                  Comments                                                    Response
                    number                  Please insert each new comment in a new row.                      Please respond to each comment

Sigma research   Guidance title   The title is imbalanced. If the assessment is about chlamydia make        Noted. It is not our intention to
                                  it about chlamydia. If it is about all STIs do not privilege chlamydia.   privilege any particular aspect of this
                                  A nodding reference to ‘other STIs’ only ensures they are not             scope.
                                  properly served. If this is ground-preparation to roll out chlamydia
                                  screening do not forestall action on other STIs by suggesting that
                                  this work has also been done.
                                  Screening and other interventions do not reduce STI transmission
                                  or conception. Interventions (should) reduce unmet needs or lacks
                                  (eg. ignorance of infection, no access to treatment, weak or absent
                                  interpersonal skills, ignorance of proper condom use, belief in STI
                                  myths, being in an abusive relationship, etc.). No one intervention       Agreed.
                                  meets all needs so no one intervention could be expected to reduce
                                  transmission in a population (even if given to everyone).
                                  Mixed programmes of intervention may reduce rates in a
                                  population. Perhaps the focus of the investigation should be on
                                  mixed programmes rather than single interventions.
                                  Perhaps the investigation should be of valid sexual health needs.         Thank you for this point.
                                  This is a political as well as empirical question.

                                     It seems strange to lump together STI prevention and                  This is a helpful clarification.
                                      conception prevention without mentioning unprotected
                                      intercourse. Perhaps the focus should be on ‘Programmes to
                                      reduce unprotected intercourse’ through the dual goals of
                                      reducing intercourse and increasing condom use when
                                      intercourse occurs




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 Stakeholder        Section                                 Comments                                                 Response
                    number                 Please insert each new comment in a new row.                   Please respond to each comment

Sigma research   Background         “The guidance will provide recommendations for good practice
                                    that are based on the best available evidence of effectiveness,
                                    including cost effectiveness.”

                                 The assessment should not be limited to effectiveness. Planners        Cost data will be considered where it
                                 also need to know about the cost of different interventions, the       is available.
                                 feasibility of interventions in different settings, acceptability of
                                 interventions to different target groups and bias in access to
                                 interventions by different target groups (which is acknowledged in
                                 the specification of under eighteen and vulnerable and at risk
                                 groups).
                                     “The guidance will support measures to achieve the government
                                     targets for improving sexual health and reducing the rate of
                                     under 18 conceptions.”
                                 Could be more specific about who, exactly, this guidance is for.       Please refer to section 4.7 in the
                                 The assessment could usefully establish what are valid sexual          scope for details of who the guidance
                                 health needs for PCT funded interventions/programmes to                is aimed at.
                                 address? Interventions should then be required to demonstrate that     Noted.
                                 they address these specific needs.
                                    “This guidance…will focus on those which are defined as one-to-
                                    one or face-to-face interactive interventions.”
                                 Face-to-face interventions can also occur in groups and so are not     Thank you.
                                 co-terminus with one-to-one interventions.

Sigma research   The need for The number of infections is not evidence of the need for guidance.        Thank you for this clarification.
                 guidance     Evidence of need would be service planners and providers being
                              ignorant of (a) what valid sexual health needs are, (b) which of
                              those needs are commonly unmet in their local population and
                              which subgroups in the population have many needs unmet (ie. are
                              vulnerable to sexual ill-health), and (c) which interventions can best
                              meet those needs for the largest number of people with the greatest
                              degree of equity.


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 Stakeholder        Section                                   Comments                                                   Response
                    number                   Please insert each new comment in a new row.                     Please respond to each comment

Sigma research   Inequalities in      “The highest burden of sexual ill health is borne by gay men,
                 sexual health        some black and minority ethnic groups, women and young
                                      adults.”
                                   The list seems to exclude only straight White men aged over 25 (ie.
                                                                                                            Noted.
                                   it excludes only about 30% of the population). It makes little sense
                                   to say the highest burden of sexual ill health is born by 70% of the
                                   population.
                                       “Individuals and groups with the greatest need for sexual health
                                       services are also those least likely to be able to access them...”
                                   This underlines the need to know about the access bias in                Agreed.
                                   interventions rather than simply their effectiveness.
                                      “In 2003, of newly diagnosed STIs among men in the UK, men
                                      who have sex with men (MSM) accounted for 56% of HIV
                                      infections”
                                   This is deeply misleading in the context of prevention. MSM              Thank you.
                                   account for about 84% of all HIV infections acquired in the UK
                                   (HPA, Focus on Prevention, p.44) and an even higher proportion of
                                   infections acquired by men in the UK.
                                      “Some of the UK’s black and minority ethnic populations are
                                      disproportionately affected by poor sexual health.”
                                   African and Caribbean people tend to have higher rates than the          We will examine the wording.
                                   White majority while Asian and Chinese people tend to have lower
                                   rates. Concurrency of sexual partners (‘unfaithfulness’) and/or
                                   having partners who are non-monogamous is probably important
                                   here as well as access to services, and intra-network sexual mixing.
                                   The scope could be more specific rather than say ‘some of the UK’s
                                   BME populations’.




                                                                       73
 Stakeholder        Section                              Comments                                                  Response
                    number              Please insert each new comment in a new row.                    Please respond to each comment

Sigma research   Trends.      You could also mention that condom use increased between 1990           Noted.
                              and 2000 but not sufficiently to off-set infection exposures due to
                              partner numbers.
                              You could say that the average length of time people have               Noted.
                              undiagnosed infections has probably increased.
                              It is problematic (and heterosexist) to list sex between men per se     Noted.
                              as a ‘risk behaviour’ when sex between men and women per se is
                              not also listed. To do so is over-determined and suggests that
                              reducing sex between men should be a population level goal to
                              reduce STIs. Sex between men is not a risk behaviour, certain
                              sexual acts between men are.
                              NSAAL suggests sex between women has become more common                 Noted.
                              also (to a greater extent than sex between men).
                              The increase in HIV diagnoses in recent years has been very much        Noted.
                              due to increases in people with HIV moving to the UK, especially
                              from Africa.
Sigma research                       “professionals and others involved in the delivery of one to
                 4.1.                one direct sexual health interventions“
                              It would be useful to be more specific about who you mean by this.      Noted.

                              Rather than ask how these professionals can bring about (i) the         Thank you for this point.
                              reduction of the incidence of STIs and (ii) the reduction of the rate
                              of teenage conceptions especially with vulnerable and high risk
                              groups, it would be better to ask how they can reduce the unmet
                              sexual health needs of their clients.
                              There seems to be a tension between the intervenors being               Noted.
                              ‘professionals’ and them coming from a wide-range of agencies and
                              possibly being unpaid.




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 Stakeholder        Section                                  Comments                                                    Response
                    number                  Please insert each new comment in a new row.                      Please respond to each comment

Sigma research   4.2             Generally I would not recognise these as ‘interventions’ as they do        An interesting distinction.
                 Interventions   not contain the minimum information (objectives and methods,
                                 settings, aims and targets) to warrant being called such. Most of
                                 them are methods, not interventions. None specify a setting, target
                                 or aim.

                                 ‘Providing information’ through talking is a method. The aim is
                                 usually an increase in knowledge.

                                 ‘Screening’ can mean simply asymptomatic testing of an individual;
                                 more conventionally though it means doing this for a high proportion
                                 of a specific population, so usually screening does not refer to an
                                 individual intervention by a population level intervention. The aim is
                                 usually an awareness of the presence of infection. [Screening is           Thank you for this clarification.
                                 rarely done alone – I think what you are referring to is ‘screening
                                 and treatment’ whose aim is awareness of infection and access to
                                 treatment drugs – the overall goal being reducing the length of time
                                 people have undiagnosed infection].

                                 ‘Brief advice’ through talking is a method. The aim is usually that        Noted.
                                 the target knows what the advisor thinks they should do. (Often
                                 indistinguishable in practice from ‘providing information’.)

                                 ‘Providing condoms’ is a method. The aim is usually having                 Noted.
                                 condoms.

                                 Counselling and cognitive behavioural therapy are not the same             Agreed.
                                 thing and one is not a subset of the other.

                                 ‘Counselling’ through talking is a method carried out by qualified         Agreed.
                                 counsellor. The aim is multifaceted, usually including clarity about a
                                 situation, awareness of a range of options, belief in the possibility of
                                 change, etc, as well as increases in knowledge and awareness.

                                 ‘Cognitive behavioural therapy’ is a method carried out by chartered       Noted.
                                                                     75
                                 psychologists. The aim is usually an ability to insert a thought
                                 between a desire and an action.
                                  ‘Skills development’ is an aim not an intervention. The methods           Agreed.
 Stakeholder       Section                              Comments                                                Response
                   number              Please insert each new comment in a new row.                  Please respond to each comment

Sigma research   General     Targets: Under 18s
                             Objectives: Advise on prevention of contraception STIs including:
                             the range of preventative methods, including emergency hormonal
                             contraception and condoms.
                             Distribute condoms along with advice.
                             Settings: At pregnancy testing services, termination services and
                             antenatal services;
                             NHS and non-NHS; schools; mobile clinics (vans); streets.
                             Aims: Targets know the potential and limitations of the range of
                             preventative methods and have access to condoms
                             Objectives: When someone is diagnosed with an STI locate their
                             sexual partners and notify them that they may have been exposed
                             to an STI and refer them to testing and treatment services. Either:
                             provider notifies partners; or Index patient notifies partners; or
                             provider notifies partners if index patient has not done so within an
                             agreed period of time (known as contract or conditional referral).
                             Settings: NHS and non-NHS; schools; mobile clinics (vans); streets.




                                                                76
 Stakeholder       Section                              Comments                                                   Response
                   number              Please insert each new comment in a new row.                     Please respond to each comment

Sigma research   General     Targets: 16–25 year old men and women
                             Objectives: Test for chlamydia opportunistically
                             Settings: Non-GUM; NHS and non-NHS; schools; mobile clinics
                             (vans); streets.


                               “The guidance will not cover an assessment of the efficacy of
                               individual contraceptive methods.”

                             The guidance will not include the sensitivity and specificity of
                             diagnostic tests but will include interventions in which those tests
                             are used (screening). Although the guidance will not include the
                             effectiveness of individual methods, it could include interventions in
                             which they are deployed – there will be differences in feasibility,
                             cost, access, acceptability, need, effectiveness and efficiency          Noted.
                             between (eg.) a GP prescribing contraception to under 18s from a
                             family practice and one going into schools to do so, or (eg.) free
                             condoms distributed to under 18s through a sports centre or
                             through a mail-order service advertised in teen-magazines.


                               “Included in the guidance will be a consideration of the evidence      Agreed.
                               of the effectiveness of the above interventions as perceived by
                               the people offered them.”

                             While individual members of the target group are well placed to say
                             whether or not the intervention was effective for them personally,       Agreed.
                             they are not qualified to say whether the intervention worked for
                             others. It is also important to distinguish whether people found the
                             intervention acceptable from whether or not it brought about its
                             intended change. Evaluations often mistake acceptability for
                             effectiveness. The target group claiming the intervention ‘worked
                             well’ is not the same thing as it being effective.


                                                                77
 Stakeholder        Section                                     Comments                                                          Response
                    number                     Please insert each new comment in a new row.                            Please respond to each comment

Sigma research   4.3                No rationale if offered in the scope for the inclusion or exclusion of          That is not the intention.
                 Interventions      particular groups of intervention. There is a danger of this piece of work
                 which will not     being seen as an exercise in justifying the role out chlamydia screening.
                 be inlcuded                                                                                 Interventions which will not be included:
Sigma research   4.4 Populations       This guidance will cover the whole population. Particular
                                       reference will be given to those groups who are at the greatest
                                       risk of STIs and teenage pregnancy and will include: MSM, some
                                       black and minority ethnic groups, young people, particularly
                                       those affected by poverty and social exclusion and have low
                                       educational achievement, and those in and leaving care, plus
                                       sex workers and refugee and asylum seekers.”
                                                                                                                    Noted.
                                    What is the rationale for this catchment? The groups most affected
                                    by (eg.) HIV and unintended pregnancy are very different. The
                                    scope starts with and is organised around methods (face-to-face,
                                    one-to-one), but here seems to realign itself to population groups.

Sigma research   4.5               “The interventions will be compared against each other and against
                 Comparators          routine care where the data are available.“

                                   But the interventions are not attempting to do the same things for the This point will be considered when we
                                   same people. How can you compare (1) advice, chlamydia screening undertake the economic analysis.
                                   and referral for under 25 year old heterosexuals in sports centres to
                                   raise awareness of chlamydia and inform those with infection, with
                                   (2) condom distribution for gay men at gay pubs and clubs to
                                   increase access to condoms, with (3) individual mentorship and
                                   training for people with learning difficulties at their homes to raise
                                   sexual assertiveness skills?

                                   THE ASSESSMENT WOULD BE MUCH MORE LIKELY TO                                      This group will be included.
                                   ACHIEVE A USEFUL OUTCOME IF IT FOCUSSED ON
                                   INTERVENTIONS FOR UNDER 18 YEAR OLD HETEROSEXUALS.



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 Stakeholder       Section                                Comments                                                  Response
                   number                Please insert each new comment in a new row.                    Please respond to each comment

Sigma research   4.6Outcome   “The aim of STI and teenage pregnancy prevention interventions
                 measures     may be defined as any activities which proactively and positively
                              support the sexual and emotional health and well being of
                              individuals, groups, communities and the wider public through the
                              reduction of the incidence of sexually acquired infection and
                              unintended conceptions.”

                              The definition is over-determined and under-specified. The aims of       Noted.
                              interventions cannot be defined as the activities of the interventions
                              as in the above sentence.

                              The aim of interventions is to reduce unmet needs; unmet needs
                              influence (but do not determine) behaviours; behaviours influence
                              (but do not determine) conceptions and infections; conceptions and
                              infections influence (but do not determine) health wealth and human
                              happiness. The ‘aim’ of STI/conception interventions could
                              therefore be set at an increase in health, wealth and human
                              happiness. But this would be a bit silly. As would setting the aim of
                              the intervention as a reduction in STI/conception rates. We can
                              conceptualise five levels of intervention/programme action:

                              STI and teenage pregnancy prevention interventions

                              Intervention objectives: Proactively and positively act, in order to,

                              Intervention aims: Reduce unmet prevention needs (eg. knowledge,
                              skills, access to resources, peer norms, etc), in order to,

                              Programme aims: Reduce population level conception and STI
                              transmission related behaviours (unprotected heterosexual vaginal
                              intercourse, taking antibiotics when infected with ST bacteria, taking
                              emergency hormonal contraception, etc), in order to

                              Programme goals: Reduce [specific population] rateconception and
                              STI transmissions, which,
                                                                   79
                              Government aims: Increase health [eg. less PID, sterility, AIDS],
                              wealth [eg. lower treatment costs, more productive workforce] and
                              human happiness [eg. less STI/conception related misery].
 Stakeholder        Section                                Comments                                                   Response
                    number                Please insert each new comment in a new row.                     Please respond to each comment

Sigma research   4.8 Research        How can one-to-one interventions contribute to the reduction
                 Questions           of STI’s and unintended teenage conceptions?

                                By reducing unmet STI/conception related needs.

                                What are unmet STI/conception related needs?

                                This is the question the assessment could more fruitfully address.

                                The range of questions regarding the factors influencing                 Noted.
                                effectiveness of interventions at meeting their aims is very
                                appropriate but presupposes we know what valid STI/conception
                                needs are.

Sigma research   4.9.2          Economic evaluation method

                                Cost-effectiveness analysis with the Quality Adjusted Life Year
                                (QALY) as the health-related outcome measure will be adopted as
                                the primary measure for the economic evaluation of public health
                                interventions and programmes. This will ensure baseline
                                comparability within the UK healthcare sector and across the
                                Institute’s programmes.

                                     The health gain from prevention interventions is determined         We anticipate a number of difficulties
                                     by the current and prospective level of an illness in a             in the health economics (public
                                     population – so it is not a solely function of the performance of   health) strand.
                                     an intervention (or programme of interventions). This is
                                     fundamentally different from the assessment of the health gain
                                     from clinical interventions. The value of any prevention or
                                     clinical intervention is also related to the other interventions
                                     currently being implemented and the relative national




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    Stakeholder            Section                                 Comments                                                 Response
                           number                 Please insert each new comment in a new row.                   Please respond to each comment

   Sigma research       4.10 Evidence   I would be concerned that the diversity of questions being asked (if   Noted.
                        for             not narrowed) will leave little room for comparisons. The Medline-
                        consideration   QALY approach is more suited to very narrow research questions

   Sigma research       4.11 Outputs    It would be useful to specify the objectives, aims, targets and most   Noted.
                                        importantly settings for each of these outputs/dissemination
                                        interventions.

Genito-Urinary Nurses   General         The document does not appear to consider confounding variables         The brief from the DH for this project
 Association (GUNA)                     associated with risky sexual behaviour such as the use of alcohol      was very broad. Time and resource
                                        and/ or drugs                                                          constraints meant that the work had to
                                                                                                               be made manageable. Where
                                                                                                               confounding variables are mentioned
                                                                                                               in the literature they will be
                                                                                                               considered.
Genito-Urinary Nurses   General         The link between acquiring an STI and the increased risk of            This risk has been acknowledged in
 Association (GUNA)                     acquiring HIV                                                          the scope.


Genito-Urinary Nurses   General         The link between unintended pregnancy and the increased risk of        This risk has been acknowledged in
 Association (GUNA)                     acquiring an STI including Chlamydia.                                  the scope.



Genito-Urinary Nurses   General         The significant interventions that occur in GU Medicine (GUM)          The scope has been amended to
 Association (GUNA)                     departments, in terms of advice about the use of condoms               include one-to-one health promotion
                                        prevention of acquiring STIs, prevention of conception and the         interventions in GUM.
                                        public health issues related to partner notification, which are
                                        initiated and undertaken by health care professionals in GUM often
                                        when an individual attends the department/ s for either a standard
                                        STI screen or screening for HIV and/ or Hepatitis B.



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    Stakeholder             Section                               Comments                                                 Response
                            number               Please insert each new comment in a new row.                   Please respond to each comment

Genito-Urinary Nurses     General     During a consultation a sexual history (SH) is taken, one of the        Noted.
 Association (GUNA)                   rationales behind taking an in depth SH is to identify high risk
                                      sexual behaviour, then to either offer an intervention or to refer to
                                      another HCP to develop strategies to reduce the risk of the
                                      acquisition of STIs and HIV.

Genito-Urinary Nurses     General     Finally, there were 1.5 million appointments made in GUM                This guidance will not cover testing
 Association (GUNA)                   departments in England during 2004, a significant number of these       and screening, other than for
                                      attendances will have been for standard STI screens, which is to be     chlamydia, however prevention
                                      encouraged, which include the screening for HIV, syphilis and if        interventions delivered at the time of
                                      appropriate Hepatitis B. We believe it will be extremely short          testing will be considered.
                                      sighted to exclude the many interventions undertaken to decrease
                                      the incidence of STIs during these consultations.

   Royal College of       General     The Royal college of Physicians and the British Association for         Thank you.
  Physicians & The                    Sexual Health and HIV welcome the initiative to review the
British Association for               evidence for effective interventions in the sphere of sexual health
Sexual Health & HIV                   and will provide appropriate input at each stage of the consultation
     (Collectively)                   process.




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    Stakeholder              Section                                   Comments                                                 Response
                             number                   Please insert each new comment in a new row.                   Please respond to each comment

   Royal College of       Section 1 Title   Under the guidance title we suggest the addition of HIV after          This has been added.
  Physicians & The                          sexually transmitted infections, otherwise it is unclear whether HIV
British Association for                     is part of this guidance. The title would then read: ‘An assessment
Sexual Health & HIV                         of interventions (including screening) to reduce the transmission of
     (Collectively)                         Chlamydia and other sexually transmitted infections (STIs, including
                                            HIV), and to reduce the rate of under eighteen conceptions,
                                            especially among vulnerable and at risk groups.’

                                            The Short title would be: ‘Interventions to prevent sexually           This has been added
                                            transmitted infections including HIV and reduce under 18
                                            conceptions’.

                                            Justification: HIV is clearly a sexually transmitted infection and a
                                            major threat to public health. Any assessment of the effectiveness
                                            and cost-effectiveness of interventions must take into account the
                                            direct impact on HIV incidence (through behaviour change) and the
                                            indirect impact by reducing other sexually transmitted infections
                                            which increase the transmissibility of HIV.

   Royal College of       Section 2         There is a lot of focus on young persons sexual health particularly    The remit given to NICE by the DH
  Physicians & The        Background        teenagers. It may not be within the scope of this guidance but         specified that NICE look at under-18
British Association for                     reducing the rate of unwanted pregnancies across all age groups        conceptions.
Sexual Health & HIV                         would be worthy of consideration.
     (Collectively)




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    Stakeholder              Section                                 Comments                                                 Response
                             number                 Please insert each new comment in a new row.                   Please respond to each comment

   Royal College of       Section 3 The   There are some factual errors. On page 4 the document includes         Noted. The scope will be amended to
  Physicians & The        need for        the following statement: ‘there were more than 1.5 million             clarify this.
British Association for   guidance        appointments made in genitourinary medicine (GUM) clinics and
Sexual Health & HIV                       696,419 new STIs were diagnosed.’ It is essential that data from
     (Collectively)                       the Health Protection Agency are used with care and are thoroughly
                                          understood. The figure of 1.5 million refers to the number of
                                          diagnoses (of all conditions, not only STIs) and other workload
                                          measures including the number of screens carried out. Individuals
                                          will be coded more than once in this system and therefore the
                                          overall figure of 1.5 million does not reflect either individuals or
                                          diagnoses. It would be advisable to rephrase this as follows: ‘Data
                                          released on 30th June 2004 by the Health Protection Agency (HPA)
                                          showed that, in 2004, 751,282 new diagnoses were seen in
                                          genitourinary medicine clinics (GUM) in the United Kingdom, (UK),
                                          an increase of 2% on 2003.’

                                          *The bullet point on page 4 repeat the points in the table and could
                                          be removed.

   Royal College of       STI             Current STI surveillance data (this applies to information here and    Noted.
  Physicians & The        Surveillance:   in the outcome measures later in the document) are limited.
British Association for   General Point   Surveillance is based on returns from GUM Services, so if capacity
Sexual Health & HIV                       has been reached and patients attend other sexual health provides,
     (Collectively)                       their information will not be collected. Surveillance of laboratory
                                          data (reports of positive isolates) is also incomplete, and there is
                                          currently no routine surveillance of STIs diagnosed in primary care
                                          or other sexual health services outside of GUM.




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    Stakeholder              Section                                  Comments                                                    Response
                             number                  Please insert each new comment in a new row.                      Please respond to each comment

   Royal College of       Suggest         In view of the public health importance of HIV/ AIDS we think that         Thank you.
  Physicians & The        additional      this merits an additional subsection. The following may be useful
British Association for   subsection on   (from HPA)
Sexual Health & HIV       HIV/ AIDS
     (Collectively)                       ‘At the end of 2003 an estimated 53,000 adults aged over 15 were
                                          living with HIV in the UK, 14,300 (27%) of whom were unaware of
                                          their infection. Since the epidemic began in the early 1980s about
                                          15,750 deaths I HIV infected individuals are known to have
                                          occurred in the UK. Currently the number of people living with
                                          diagnosed HIV is rising each year due to increased numbers of new
                                          diagnoses and decreasing deaths due to antiretroviral therapies.

                                             There were 6,606 new infections diagnosed in the UK during
                                              2003, 58% (3801) of these were amongst heterosexuals, with
                                              gay and bisexual men accounting for 26% (1735).

                                             The increase in number of newly diagnosed infections is the
                                              result of a combination of factors, but is largely contributed to by
                                              the migration of people from areas of the world where there is a
                                              high prevalence of HIV, such as sub-Saharan Africa.

                                             The number of new infections diagnosed in gay and bisexual
                                              men is expected to be the highest for over 10 years, with 1,735
                                              diagnoses reported so far for 2003.

                                             In addition, the number of heterosexual HIV diagnoses likely to
                                              have been acquired in this country has increased from 139 in
                                              1998 to 341 in 2003.’

                                          Under consequences of poor sexual health there are many that
                                          have been omitted, including complications in men, (e.g. sexually
                                          acquired reactive arthritis and epididymitis), chronic pelvic pain in
                                          women, stigma and the breakdown of relationships, intimate partner
                                          violence, mortality from HIV, congenital syphilis and intrauterine
                                          death, cardiovascular and neurological complications from
                                          untreated syphilis.                  85
    Stakeholder              Section                                   Comments                                                    Response
                             number                   Please insert each new comment in a new row.                      Please respond to each comment

   Royal College of       Inequalities in   This section is generally well written and highlights the issues.         Noted.
  Physicians & The        sexual health     However, within the scope, most of theses highlighted areas will not
British Association for                     be covered. There are targets for offer and uptake of HIV screening
Sexual Health & HIV                         and targets for Hepatitis B vaccine uptake in higher risk groups with
     (Collectively)                         hard outcome measures as part of the National Strategy. HIV is the
                                            most expensive STI in terms of public health impact.

                                            The bullet point on men who have sex with men is incorrect (see
                                            data above – MSM account for only 26% of newly diagnosed HIV in
                                            2003). MSM account for 25% of gonorrhoea in men, and 54% of
                                            syphilis in men.

   Royal College of       Trends            Under this section it is essential to point out that data on STI trends   Thank you. We are aware of these
  Physicians & The                          are becoming increasingly difficult to interpret as service provision     complexities.
British Association for                     is shifting more to primary care, yet there are no adequate
Sexual Health & HIV                         surveillance mechanisms to capture this. It would also be helpful to
     (Collectively)                         point out that an increase in the numbers of STI diagnosed may be
                                            a positive outcome – for example the numbers of cases of
                                            Chlamydia will rise substantially in the coming years due to the
                                            increased availability of screening and the increased sensitivity of
                                            diagnostic tests.

                                            At the end of the paragraph on sexual behaviour it may be useful to
                                            add that the proportion of men reporting having paid a woman for
                                            sex in the previous 5 years has increased from 2.0% in 1990 to
                                            4.2% in 2000.




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    Stakeholder              Section                                  Comments                                                    Response
                             number                  Please insert each new comment in a new row.                      Please respond to each comment

   Royal College of       Section 4 The   Opportunities for one – to – one                                           We are aware of these complexities
  Physicians & The        Guidance                                                                                   and an important part of the NICE
British Association for                   The intervention considered is the delivery of one to one direct           public health guidance is the
Sexual Health & HIV                       access within a consultation or other interaction. It is crucial to look   involvement of the Implementation
     (Collectively)                       at the different sites where one to one interventions take place, and      Team during development to address
                                          how changes to service provision and delivery may be altering this.        these issues.

                                          For example, the tragedy of services being unable to cope with
                                          demand is that there is potential for less emphasis on health
                                          promotion, i.e. less time for precisely the interventions that the
                                          consultation is addressing. People found to have an STI or HIV
                                          may receive treatment but not have health promotion due to lack of
                                          clinic resources. Many patients may not get a follow- up visit –
                                          these are increasingly done on the telephone. To our knowledge
                                          this change in service provision has not been evaluated in terms of
                                          partner notification outcome or health promotion opportunities. At
                                          the time of attending a service and certainly receiving a positive
                                          sexually transmitted infection diagnosis ‘patients’ are more
                                          receptive to health promotion messages. Some health care
                                          workers within the same setting have better skills. Application in
                                          different settings may also have an impact e.g. a nurse
                                          performance in GPs may differ from the sexual health specialist
                                          nurse. These should be considered as part of the synthesis of
                                          research evidence.

                                          Patients who have a sexual health screen, in GUM or elsewhere,
                                          may also not re-attend for results. Pressure to cope with increased
                                          demand has led some GUM clinics to operate a ‘ no news is good
                                          news’ policy, where patients are old that they will be contacted only
                                          if there is an abnormal result. Again this reduces the opportunity for
                                          face – to – face intervention and post- test counselling.

                                          We therefore think that it is essential to consider the impact of
                                          changes in service on the ability to deliver one – to – one
                                          interventions. There is little point in finding out that a ten minute
                                                                                 87
                                          counselling session or condom skill intervention is effective if the
                                          clinics are structured only to offer a rapid diagnostic and treatment
                                          services with no time for these additional functions.
    Stakeholder              Section                               Comments                                                  Response
                             number               Please insert each new comment in a new row.                    Please respond to each comment

   Royal College of       Outreach      It is unclear what kind of outreach services will be included within    Outreach services will be considered.
  Physicians & The        Services      this review. Outreach has been shown to be an important way of          The specific kinds will depend upon
British Association for                 reaching some vulnerable populations either with health promotion,      the literature available.
Sexual Health & HIV                     advice and condom distribution, or with screening, or with full
     (Collectively)                     clinical services. Outreach services can be expensive and often
                                        take many years to show an impact but clearly need to be
                                        considered as they provide key opportunities for effective one – to –
                                        one interventions.

   Royal College of       Section 4.3   The Scoping document states that standard sexual health screens         One-to-one interventions delivered at
  Physicians & The                      in GU departments and screening for HIV, syphilis and hepatitis B       the time of screening will be
British Association for                 infection will not be included. We are very concerned about this.       considered – the screening itself will
Sexual Health & HIV                     There are over 750,000 sexual health screens carried out in GU          not.
     (Collectively)                     Clinics each year and each of these provides the opportunity for
                                        one – to – one intervention to reduce further risk. There is a large
                                        body of international research on the impact of HIV and STI testing
                                        and counselling and it would be odd to exclude this from the scope.

                                        The definition of a standard sexual health screen is required. Many
                                        so-called asymptomatic patients inevitably turn out to have some
                                        unrecognised symptoms on questioning and so should be included.
                                        It is problematic differentiating between testing and ‘screening’.




                                                                           88
    Stakeholder              Section                               Comments                                                    Response
                             number               Please insert each new comment in a new row.                      Please respond to each comment

   Royal College of       Screening     The scope should include the possible negative consequences of            Noted.
  Physicians & The        outside the   expanded screening outside of GUM, where single tests may be
British Association for   GUM           carried out. For example the Chlamydia screening programme
Sexual Health & HIV                     does not include routine screening for HIV and other STI as
     (Collectively)                     recommended in GUM settings. HIV testing has been undertaken
                                        in non-health care settings and effectiveness and value for money
                                        so should be included. Single test approach, when it is known that
                                        other STIS are multiple, should be part of evaluation.

                                        The question of the effectiveness and efficacy of Chlamydia
                                        screening is linked to that of HIV testing – in particular, the rate of
                                        undiagnosed HIV. Reducing the rate of undiagnosed HIV is a
                                        priority first set in the National Strategy for Sexual Health and HIV.
                                        There is evidence that widening of Chlamydia testing outside the
                                        GUM setting may tend to reduce the early diagnosis of HIV.
                                        Chlamydia is known to be more common in individuals of some
                                        black ethnic minority groups, which are also at increased risk of
                                        HIV. Data from the NATSAL study showed that patients diagnosed
                                        with Chlamydia in primary care were mush less likely to have had
                                        an HIV test than those tested in the GUM setting. If an increasing
                                        proportion of Chlamydia tests take place outside the GUM setting,
                                        and are not accompanied by HIV testing, it is possible that a smaller
                                        proportion of HIV infected individuals will be diagnosed through
                                        early voluntary counselling and testing.

                                        It is therefore essential that the evaluation of Chlamydia testing in
                                        non-GUM settings should take into account the tendency of a
                                        particular model of care to increase, or to decrease, the rate of
                                        undiagnosed HIV and not to regard this as a separate issue.




                                                                            89
    Stakeholder              Section                                  Comments                                                  Response
                             number                  Please insert each new comment in a new row.                    Please respond to each comment

   Royal College of       Pharmacy         A ‘Chlamydia Pathfinder’ pilot ‘Screening’ programme has recently       Noted.
  Physicians & The        testing for      been announced in which Boots will be undertaking Chlamydia
British Association for   chlamydia        Screening. Although an evaluation tender has been published,
Sexual Health & HIV                        details of the project have not been widely released. It would be
     (Collectively)                        useful to include any evaluation of the one – to – one interventions
                                           associated with this scheme.

   Royal College of       Post- Exposure   PEPSE involves the unlicensed use of HIV medication to protect          Evaluation of PEP as a public health
  Physicians & The        HIV              exposed, or potentially exposed, individuals against HIV after          prevention intervention will
British Association for   Prophylaxis      sexual exposure. New guidelines have been produces, which are           considered.
Sexual Health & HIV       after sexual     the subject of some controversy in the UK. Some GUM clinics are
                          exposure
     (Collectively)                        spending a significant proportion of their budgets on this treatment
                          (PEPSE)
                                           to prevent the transmission of HIV (an STI). Evidence for its
                                           effectiveness is both incomplete and controversial. The Terence
                                           Higgins Trust have undertaken a publicity campaign to promote the
                                           use of PEPSE. The evidence base around its effectiveness in
                                           preventing HIV infection is controversial. There maybe negative
                                           public health gain in that unsafe sex, already widely practised, will
                                           increase as infected individuals may adopt more risky behaviour.

                                           Evaluation of the effectiveness and efficacy of PEPSE, with             Evaluation of the clinical effectiveness
                                           evidence based recommendation taking into account public health         of PEPSE is outside the remit of the
                                           outcomes as well as clinical data, is an urgent and important topic     Centre for Public Health Excellence
                                           for review within the scope for the review required by the              and would need to be considered by
                                           department of health. This is an expensive one to one intervention      the clinical teams at NICE.
                                           in terms of costs of drugs and time with patients. This is not funded
                                           by commissioners and is adding to HIV funding deficits. This
                                           should be included in the scope.




                                                                              90
    Stakeholder              Section                               Comments                                                  Response
                             number               Please insert each new comment in a new row.                    Please respond to each comment

   Royal College of       Public and    On Page 9 it is stated that consideration by people offered the         Noted.
  Physicians & The        Patient       intervention will be undertaken. Engaging those diagnosed with
British Association for   Involvement   sexually transmitted infections other than HIV has proved
Sexual Health & HIV                     problematic. Some patients actually refused to see health advisers
     (Collectively)                     as they do not want to address their sexual behaviour and risks of
                                        transmission or infection. The evidence base available is I think
                                        lacking. Some soft data may be available e.g. patient satisfaction
                                        within specific services. Patients who may speak up are those who
                                        are badly effected by complications e.g. infertility. This will
                                        inevitably be a very biased sample. Clearly this is an important
                                        area to address but challenging.

   Royal College of       Section 4.5   Routine care needs to be defined                                        Noted.
  Physicians & The
British Association for
Sexual Health & HIV
     (Collectively)
   Royal College of       Section 4.6   Primary Health outcome should include, where possible, re-              Thank you. The outcomes reported
  Physicians & The        Outcome       infection rates (maybe possible to do this by the proxy measure of      will largely be determined by the
British Association for   Measures      the proportion of people with an STI who have had one before) and       available literature.
Sexual Health & HIV                     repeat pregnancies and/ or terminations or pregnancy. Few studies
     (Collectively)                     have been undertaken looking at re-infection rates certainly in the
                                        UK. Previously diagnosed sexually transmitted infections is
                                        routinely collected albeit in paper form at GUM Clinics. This may be
                                        a useful indicator.

                                        HIV infection in people who have had previous negative tests is
                                        also a key indicator, since they will have had the opportunity for
                                        intervention.

                                        There are problems with using reduction in the rate of STIs as an
                                        outcome measure. (See above). It is important that sexually
                                        transmitted infections are identified and identifying more infections
                                        may be a better PH outcome. The availability of different diagnostic

                                                                            91
    Stakeholder              Section                               Comments                                                   Response
                             number               Please insert each new comment in a new row.                     Please respond to each comment

                                        tests in different settings also has an impact on this outcome
                                        measure.

                                        Appropriate and timely treatment is an important health outcome.
                                        Changing sexual behaviour is difficult. How some of the
                                        intermediate outcome measures will be obtained e.g. intention to
                                        use condoms is challenging. Some are very ‘soft’. Access to rapid
                                        diagnosis and treatment given the difficult of changing sexual
                                        behaviour is a key component in reducing transmission of infection.
                                        And this is an intervention on a one basis that must be included.

                                        Regductions in numbers of partners is a difficult outcome to relate
                                        to the interventions, since most interventions stress safer sex rather
                                        than partner reduction is an unlikely outcome, whereas consistent
                                        and effective use of condoms is more appropriate.

                                        One outcome that may be important relates to the circumstances of
                                        first sexual intercourse, not merely its timing. The objective of many
                                        interventions is for young people to make informed choices about
                                        when, with whom and in what setting they should have sex. Too
                                        many young people feel pressured into earlier or inappropriate
                                        sexual activity.

   Royal College of       Section 4.8   It is important that the quality and consistency of any interventions    Noted.
  Physicians & The        Research      is included. CBT may be effective in some small studies but
British Association for   Questions     ensuring consistent quality in the delivery in practice can be very
Sexual Health & HIV                     difficult.
     (Collectively)
                                        While this guidance is unlikely to be able to answer it, the question
                                        of measuring the impact of new initiatives, such as the Chlamydia
                                        screening programme, at the population level must be a priority for
                                        the future.



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