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Advise for data management DRS Tanzania

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					Mission to support epidemiological and operational research of the


    National Tuberculosis and Leprosy Programme, Tanzania




                      1 May – 08 May 2011




                          Report no. 21




                  Frank van Leth, MD MSc PhD
                   Senior epidemiologist KNCV
Executive summary



1. To finalize the preparations for the TB prevalence survey.

The finalization of the preparations for the TB prevalence survey has been on hold for quite
some time. The main reason for this was the uncertainty around the funding of the study.
With support of the WHO task force on impact measurements, there has been considerable
progress made in the solving this issue.
        It was felt that there was need for a final push of the preparations and address the
outstanding issues that have been identified and raised for some time by the Technical
Consultant. A single workshop of 1 week was organised with all senior personnel from the
survey team for discussion and finalization of documents. The team welcomed Dr. Onozaki
(WHO Geneva) and Dr. Nkhoma (WHO Africa) to the discussions.
        All outstanding issues were indeed discussed and agreed upon. These will be
incorporated in the final versions of the protocol, SOPs, field manual, and training manual. The
survey team finalized all SOPs needed for the survey by general discussions and agreement.
The SOPs were written using a generic template for easy reference in the field
        At a final meeting, the survey team discussed the timeline for survey activities, and
the development of the training session. It is anticipated that the first official cluster of the
survey will be visited around 15 November 2011.
        At a discussion between the PM, Dr. Onozaki, Dr. Nkhoma, and the TA consultant from
KNCV, there was an expressed need to finalize funding for future TA. In the last 6 years TA
funds were received from the Dutch and British government to KNCV. Both funding streams
dried up. Funding from OGAC can be used for the current visit and the training visit. If no
further finding is secured, then the TA for the survey will stop. It was agreed that this should
be prevented, since the continuous contribution and commitment from KNCV to this survey
(and other research activities over the years) is much appreciated.




                                                  1
Acknowledgements


I would like to thank the following persons and organizations:
Dr. SM Egwaga, NTLP Programme Manager, for his invitation to Tanzania.
Dr. N Simkoko, WHO office Dar es Salaam, for organizing in-country arrangements.
Dr. I. Onozaki and Dr. W. Nkhoma for their willingness to participate in the discussions



Terms of reference


      1. To finalize the preparations for the TB prevalence survey.



Abbreviations used


CTRL             Central Tuberculosis Reference Laboratory
DRT              Drug resistance test
GPS              Geographical Positioning System
NTLP             National Tuberculosis and Leprosy Programme
PM               Programme Manager
PST              Prevalence survey Tanzania
TB               Tuberculosis
TST              Tuberculin Skin Test
SOP              Standard Operating Procedure




                                                2
1. To finalize the preparations for the first national TB prevalence survey


Current documentation

The basis for the discussion is the unfinished protocol based on the version of 2006, SOPs for
selected activities (version 1.0; June 2011), the first draft of the field manual, and the generic
training manual designed by KNCV Tuberculosis Foundation.


Addressing outstanding issues

During previous visits from Dr. van Leth, a list of outstanding issues for final decisions has
been collated and reported upon in subsequent mission reports. With the full survey team, and
additional input form Dr. Wilfred Nkhoma (WHO Africa) and Dr. Onozaki (WHO Geneva) all
these outstanding issues are addressed and decided upon. The following decisions were made:


       Pre-survey visit
            o    Identify also nearest health facility
                          Inform staff of possible referrals from the survey
       Community sensitization
            o    Done prior to arrival of survey team
            o    By the enumerators
       Sub-sampling
            o    Needed when < 700 or > 800 adults in cluster
       Eligibility
            o    All permanent residents
            o    Occasional visitors who have slept at least 2 weeks in the household
            o    Known TB cases not excluded
                          Gives information on NTLP services
       Consent procedure
            o    Assent needed 15-17 years
            o    Group consent instruction but time for private questions at reception desk
                          At reception formal signing of form with witness
       The adult register needs information on eligibility and enrolment
            o    Columns will be added
       All participants get a serial number at arrival
       Pregnancy
            o    Assessed by asking
                          No asking for last menstrual period
                          No urine test
            o    No exclusion for X-ray
                          All women get a gonad protection apron


                                                  3
   Sputum collection
        o   Spot – morning – spot
        o   Morning specimen untouched to CTRL for culture
                      CPC if needed (a-priory selected clusters)
        o   Stains stored
        o   DST for patient management
                      For surveillance is the wrong sampling frame
   Confirmation positive LED reading
        o   By 2nd reader in the field
   HIV test results
        o   Positive send for 2nd test
        o   Negative send for repeat test after 3 months
   Data entry in the field
        o   Storage on mobile device and ‘data cloud’
        o   2nd data entry for selected form and variable at central level
   Identification of survey staff
        o   Identification tags
        o   T-shirts
   Need for additional forms and registers
        o   Referral form
        o   Consent form for information
                      In picture format?
        o   Consent form for signing
        o   HIV consent form
   Add-on studies
        o   TST survey
                      Community based due to changes in consent requirements
                              Post meeting note: eventually deleted from activities
        o   GPS reading of each household
        o   Population controls
                      To calculate population attributable risks
                              Suspect but non-case is not an adequate control
                      10 per cluster
                              Divided over all days of field work to avoid clustering
        o   Passively identified TB cases in nearly DOTS centre
                      Assumed to be similar to active cases if active cases would have
                       presented themselves passively
                      Needed for delay and assessment of incidence




                                              4
Standard Operation Procedures

Initial standard operating procedures were designed in a workshop in 2008. These were never
updated with the remarks of the Technical Consultant. Therefore it was needed to assess
which op the SOPs were still valid, which needed updating, and which were missing all
together. This rewriting of the SOPs took a very long time (2.5 days) but was a great way of
getting to grips with all activities being performed by the different teams. The SPOS were fully
finalized in a final assessment session in June 2011. All SOPs were drawn up with a similar
lay-out:
       Objective and scope
       Abbreviations
       Tasks, responsibilities, accountability (in Table format)
       Safety and environment
       Procedures (detailed description of each)
       Materials needed
       Related documents
       References
A list of all prepared SOPs is reported in Appendix 1


Time lines

The survey team discuss tight time lines for the reaming tasks. The survey team
acknowledged that there is a great urgency to have the survey started at last.
Key milestones are:
       Update all protocols and manuals
             o   Mid-July 2011
       Final budget
             o   Mid-July 2011
       Recruit human resources
             o   End July 2011
       Conduct training
             o   Early Spetmber 2011
       Conduct pilot study
             o   Early October 2011
       Start survey activities in first cluster
             o   15 November 2011


Technical Assistance

At a discussion between the PM, Dr. Onozaki, Dr. Nkhoma, and the TA consultant form KNCV,
there was an expressed need to finalize funding for future TA. In the last 6 years TA funds



                                                   5
were received from the Dutch and British government to KNCV. Both funding streams dried
up. Funding from OGAC can be used for the current visit and the training visit. If no further
funding is secured, then the TA for the survey will stop.
        It was agreed upon that this should be prevented, since the continuous contribution
and commitment form KNCV to this survey (and other research activities over the years) is
much appreciated.


Conclusions

All activities for a speedy start of the survey are finalized are planned to be finalized in due-
course. All outstanding issues are resolved. There is an urgent need to find funding for TA to
the survey. Without this, the support has to stop after the training of the survey team




                                                 6
Appendix 1: All available SOPs for the prevalence survey


      Pre-survey visit
      Community sensitization
      Population listing
      Census taking
      Obtaining consent
      Conduction interviews
      Field microscopy
      Field X-ray taking
      HIV testing
      Referral
      Central laboratory
      Central X-ray reading
      Selection and interviewing passively identified cases
      Coordination
      LED microscope maintenance
      X-ray equipment maintenance




                                              7
Appendix 2: proposed time lines


                                WAY FORWARD FOR      TB PREVALENCE SURVEY 2011
S/N   Activity           Time        Responsible     Task Team                 Technical                    Financial
                         Frame       Person                                    Assistance                   Support
1     Protocol and       2nd week    Frank L         Egwaga, Kamara, Rugola,   global task force,
      consent            July 2011                   Mfinanga, Mbazi           KNCV
2     Field manual       2nd week    Frank L         kamara, alex, Mbazi       global task force,
                         July 2011                                             AFRO, KNCV
3     Training manual    2nd week    Frank L         kamara, alex, Mbazi       global task force,
                         July 2011                                             AFRO, KNCV
4     Contact with       3rd week    egwaga          kamara, alex
      clusters           July 2011
5     Budget             2nd week    kamara          mbazi, kamara, egwaga,            global task force,
                         July 2011                   mfinanga                          AFRO, KNCV
6     Preparing the      2nd week    kamara          range, rugola, mbazi, aloisia,
      training slides    July 2011                   catherine, bandio, lulu, mzeru,
      (PPT)                                          chonde, basra, chande,
                                                     raymond, matiku
7     Finalization of    4th week       kamara       range, rugola, mbazi, aloisia,
      PPT                July 2011                   catherine, bandio, lulu, mzeru,
                                                     chonde, basra, chande,
                                                     raymond, matiku
8     Recruits HR        19 - 22 July   kamara       mbazi, kamara, egwaga,
                                                     mfinanga
9     Training HR        5- 9 Sept      kamara       mbazi, kamara, egwaga,            global task force,
      central                                        mfinanga                          AFRO, KNCV
                                                                                       PHILIPS
10    Conduct pilot      19 – 23        kamara       mbazi, kamara,   egwaga,          KNCV, AFRO
      study (rural)     Sept                         mfinanga
11    Review pilot      26 - 30         kamara       mbazi, kamara,   egwaga,          KNCV, AFRO
      study - rural     Sept                         mfinanga
12    Conduct pilot     3 - 7 Oct       kamara       mbazi, kamara,   egwaga,          KNCV, AFRO
      study (urban)                                  mfinanga
13    Assess the pilot  11 -13 Oct      kamara       mbazi, kamara,   egwaga,          KNCV, AFRO
      results                                        mfinanga
14    Ammendment of 18 - 21 Oct         kamara       mbazi, kamara,   egwaga,          KNCV, AFRO
      manuals                                        mfinanga
15    Survey            july 26 -       kamara       mbazi, kamara,   egwaga,          KNCV, AFRO
      coordinator       august 6                     mfinanga
      training
16    Launch           15-nov           egwaga       mbazi, kamara, egwaga,            global task force,   GFATM,
      ceremony                                       mfinanga                          AFRO, KNCV,          PATH
                                                                                       phillips, PATH,
                                                                                       CDC, USAID,
                                                                                       GLRA, ICAP,
                                                                                       PHARMACCESS,
                                                                                       WCO, MOH,
                                                                                       GFATM
17    Start survey      16-nov          egwaga       mbazi, kamara, egwaga,            global task force,   GFATM,
                                                     mfinanga                          AFRO, KNCV           PATH
18    Complete four     18-dec          kamara       mbazi, kamara, egwaga,
      clusters                                       mfinanga




                                                 8
Appendix 3: Itinerary


Sunday 1 May        Flight Amsterdam – Dar es Salaam


Monday 2 May        Travel Dar es Salaam – Bagamoyo
                    Discussing outstanding issues field work / organization
Tuesday 3 May       SOP writing and discussion
Wednesday 4 May     SOP writing and discussion
Thursday 5 May      SOP writing and discussion
                    Travel Bagamoyo – Dar es Salaam
Friday 6 May        Discussion on training
                    Discussion on time lines
                    Discussion of finance for TA
                    Flight Dar es Salaam – Amsterdam


Saturday 7 May      Arrival Amsterdam




                                             9

				
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