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STI Update 2011

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					                                                                                                                                           2011 APN Conference
                                                                                                                                           8B: STI Update




                                                                                    STI Update Topics

STI Update 2011                                                                         STI overview and
                                                                                        epidemiology
New STD Treatment Guidelines                                                            STI screening
                                                                                        recommendations
                                                                                        CDC STD Treatment
                         Craig Roberts, PA-C, MS                                        Guidelines
                         University Health Services
                         University of Wisconsin-Madison




Sexually Transmittable Infections                                                   STI annual incidence (new infections)
amebiasis                       human papillomavirus                                 Trich:                 7 million cases (estimate)
chancroid                       lymphogranuloma venereum                             HPV:                   6 million cases (estimate)
chlamydia                       molluscum contagiosum                                HSV:                   1.6 million cases (estimate)
gonorrhea                       mycoplasma genitalium                                Chlamydia:             1.2 million cases (reported)
granuloma inguinale             pediculosis
                                                                                     Gonorrhea:             300K cases (reported)
group B strep                   pelvic inflammatory disease
                                                                                     HIV:                   56K cases (estimate)
hepatitis A, B, C               scabies                                              Hepatitis B:           46K cases (estimate)
herpes simplex virus            shigellosis                                          Syphilis:              14K cases (reported)
HIV                             syphilis
                                trichomoniasis
         a short list…
                                                                                Source: CDC 2010; Weinstein,Berman and Cates, Fam Plan Pers 2004




Why Diagnose and Treat STIs?                                                       STIs in U.S. Adolescents
                                                                                   NHANES prevalence data
   Burden: ~19 million infections in the U.S. annually
   Health consequences:                                                            Representative national sample of girls ages14-19
   ◦ Women’s reproductive health                                                   tested for common STIs in 2003-2004
       untreated chlamydia (CT) or gonorrhea (GC) may lead to pelvic               Prevalence of one or more STIs: 25.7%
       inflammatory disease (PID)
       leading cause of infertility; nearly 24,000 cases annually in the           Prevalence among sexually active: 39.5%
       U.S.                                                                        Disease specific prevalence:
   ◦ Infant mortality/morbidity
       Neonatal HIV, herpes simplex virus (HSV) and congenital syphilis
                                                                                    ◦   HPV types 6/11/or any high risk (PCR): 18.3%
   ◦ HIV transmission (2-5X risk with co-existing STI)                              ◦   Chlamydia (NAAT): 3.9%
   ◦ Cervical, vulvar, anal and pharyngeal cancers (HPV)                            ◦   Trichomoniasis (PCR): 2.5%
   Health care cost: $16.4 billion (2009)†                                          ◦   HSV-2 (serology): 1.9%
                                                                                                                                        Forhan SE et al, Pediatrics 2009

                                              †Persp   Sex Rep Hlth, Dec 2009




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                                                                                                                                                                  8B: STI Update




                                                                 Age Distribution of Reportable STDs in Wisconsin
  Populations at Greatest Risk for STIs                          (GC, CT, PID, syphilis)
  Youth
  ◦ nearly 50% of STIs estimated to occur in 15-24 year olds                        2000


  Racial/ethnic minorities                                                          1800

                                                                                    1600
  ◦ STDs among highest of all racial/ethnic health disparities                      1400                                                the “youth-shaped curve”
  ◦ African-Americans: 71% of GC, 48% CT, 52% syphilis




                                                                   Reported cases
                                                                                    1200

  ◦ Over last 5 years syphilis cases increased more than150%                        1000

    among young African-American men                                                    800


  Men who have sex with men (MSM)                                                       600


  ◦ account for 62% of syphilis cases in 2009
                                                                                        400

                                                                                        200
  ◦ HIV incidence rates 60X higher than non-MSM                                          0

  ◦ high rates of HIV co-infection (~50%)




                                                                                              1

                                                                                                  5

                                                                                                      9

                                                                                                          13

                                                                                                               17

                                                                                                                    21

                                                                                                                         25

                                                                                                                              29

                                                                                                                                   33

                                                                                                                                        37

                                                                                                                                              41

                                                                                                                                                   45

                                                                                                                                                        49

                                                                                                                                                             53

                                                                                                                                                                  57

                                                                                                                                                                       61

                                                                                                                                                                            65

                                                                                                                                                                                 69

                                                                                                                                                                                      73
                                                                                                                                        Age



                                                                  Source: Wisconsin Division of Public Health




CDC STD Treatment Guidelines                                     2010 STD Treatment Guidelines
                                                                                                               Available at www.cdc.gov/std/treatment/2010/


  Authoritative source of STD
                                                                                Published in MMWR Dec 17
  treatment and management                                                      Primary changes include:
  Screening, prevention and                                                         ◦    Revised gonorrhea treatment regimens
  vaccination strategies, plus                                                      ◦    Revised guidance on evaluation and management of syphilis
  treatment regimens                                                                ◦    Expanded prevention guidance, incl. HPV vaccine for men
  Updated q 4-5 years                                                               ◦    Expanded guidance on screening in special populations
  Pocket guides, wall charts,                                                       ◦    Trich – rescreen infected women 3 mo after treatment
  slide set, PDA versions
                                                                                    ◦    Chlamydia & GC – rescreen infected men 3 mo after treatment
  Download or order at
                                                                                    ◦    Bacterial vaginosis – added alternative treatment regimens
  www.cdc.gov/std/treatment
                                                                                    ◦    New HPV screening, genital wart treatment options




STD Screening Guidelines Simplified                                Screening Simplified, continued
1. Sexually active adolescents and young adults ≤25:
 ◦ Chlamydia: screen all women annually, consider in men         3. Men who have sex with men (MSM):
 ◦ Gonorrhea: screen women at increased risk                       ◦ HIV and syphilis serology: screen annually
 ◦ HIV: screen all men and women once                              ◦ Urine GC and chlamydia: screen annually
                                                                   ◦ Rectal GC and chlamydia: if receptive anal intercourse
2. Pregnant Women:                                                 ◦ Pharyngeal GC: if receptive oral sex
                                                                   ◦ Hepatitis B: screen once (HBsAg) if not immunized
 ◦ Screen for CT, GC, syphilis, HIV, HBV in 1st trimester
                                                                     prior to onset of sexual activity
 ◦ Repeat in 3rd trimester if new partners
                                                                   ◦ HCV: if HIV+, or injection drug use history
                                                                                                                                                                                 new




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                                                                                                            8B: STI Update




   Screening Simplified, continued                               STD Diagnostics
                                                                 Nucleic Acid Amplification Tests (NAATs)
4. All other adults age >25:                                         NAATs for chlamydia and GC are standard
  ◦ Do selective screening based on risk                             NAATs available for trich and herpes (ie PCR)
     multiple partners since prior screening, or
                                                                     Real-world sensitivity and specificity is usually >99%
     partner has other partners, or
     other STI diagnosis
                                                                     NAATs can be used for nongenital sites (rectal and
                                                                     pharynx) but are not FDA-cleared; lab must validate
  ◦ Chlamydia and HIV for most heterosexual adults
                                                                     Limitation: can’t monitor for drug resistance
  ◦ Add GC, syphilis, hepatitis only if risk dictates
                                                                     Growing commercial availability of point-of-care rapid
  ◦ Annual screening if higher risk, multiple partners, etc.
                                                                     tests for trich, BV, HSV, HIV




                                                                     Chlamydia:
   Chlamydia: overview                                               Changes in 2010 Treatment Guidelines
   1.2 million reported cases in US annually
   Most common reportable STI                                           Emphasis on routine screening in women
   Ascending infection    [+/-PID], Infertility                         Encourages selective male screening
   Many missed opportunities for screening                     new      Rescreen women & men 3 mo after treatment
   ◦ UTI syndromes: dysuria is most common sx in men                    Use NAATs for testing at any anatomic site
     and women
                                                                        Self-collected vaginal swab is test specimen of
   ◦ Routine medical and reproductive health exams
                                                                        choice for women (if available)
   ◦ Most women, many men asymptomatic
                                                                        Expedited partner therapy should be offered




Chlamydia Screening Recommendations
U.S. Preventive Services Task Force, 2007
                                                                Chlamydia Screening: Males

  Routinely screen all sexually active women
  aged <25 years, annually (A)                                   No guidelines                       Correctional facilities

  Screen women aged ≥25 years if they are at                   recommending for
  increased risk (new or multiple partners) (A)                    or against                             STD clinics

  Screen all pregnant women at 1st prenatal visit (B)          Selective screening                Adolescent-serving clinics
  Rescreen women 3-4 months after treatment                    in high-prevalence
  ◦ prior infection within 6 mo now recognized as an           populations may be                            MSM
    important risk factor for chlamydia                             beneficial:
                                                                                                       Multiple partners




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                                                                                                         8B: STI Update




Chlamydia Testing with NAATs                                    Chlamydia - Treatment
 Combination test for CT/GC typical
 ◦ can use CT alone, with reflex to GC, for lower risk women    Recommended:
 Initial-void urine specimen (men or women)                     ◦ Azithromycin 1g po single dose, $35
                                                                    500mg tabs are better tolerated than1g sachet powder
 ◦ must be a “dirty” catch, first 15-30ml only
 ◦ no pelvic exam required                                      ◦ Doxycycline 100mg po BID X 7 days, $10
 Self-collected vaginal swab preferred when
 available (highest sensitivity)                                Alternatives:
 Don’t repeat testing within 4 weeks of treatment               ◦ Erythromycin 500 mg QID X 7 days, $10
 ◦ risk of false positive result due to residual chlamydia      ◦ Levofloxacin 500mg QD po X 7 days, $100
   DNA (rescreen at 3 months instead)                           ◦ Ofloxacin 300mg po BID X 7 days, $75




 Case 1                                                         Gonorrhea: overview

    27 yo female with intermittent dysuria
                                                                90% decrease in incidence over last 30 years
    ◦   no hematuria/frequency/fever/back pain
                                                                Overall prevalence in 18-26 y.o. is 0.4%; rates in
    ◦   2 male partners last 90 days, one unprotected
                                                                blacks are 20X higher than whites
    ◦   no prior UTI history
    ◦   last screening for chlamydia 3 years ago
                                                                Infection more common in specific risk
                                                                populations:
    Is chlamydia part of the differential? Yes
                                                                 ◦ Men who have sex with men (MSM)
    Should she get tested?         Yes                           ◦ Urban, low income (esp. African American)
    How would you test?          First void urine NAAT          Antimicrobial resistance is a growing problem




 Gonorrhea Screening                                            Gonorrhea Treatment Overview
 Screen women if increased risk                                Quinolone resistance is widespread
 ◦ age < 25 (CDC)                                              ◦ Do not use single dose cipro to treat GC
 ◦ other STIs, new/multiple partners, contact, drug use,       Few alternatives in the pipeline
   prior infection, sex workers (USPSTF)
                                                               3rd gen cephalosporins the only real choice
 Screen MSM routinely and use NAATs for all                    Penicillin allergy is not a contraindication to using
 anatomic sites of exposure (pharynx, anal)                    cephalosporins
 No evidence supports routine screening of low                 If cephalosporin allergy – give azithromycin 2g
 risk women or men (e.g. at annual gyn exam)                   single dose      new




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                                                                                                                                       8B: STI Update




Gonorrhea Treatment
changes in 2010 guidelines                        new
                                                                                  Expedited Partner Therapy                                       new


    Preferred: Ceftriaxone 250 mg IM single dose PLUS                             Provide extra Rx or meds to your patient to give
      Azithromycin 1gm single dose or doxy 100mg BID                              to their partner(s)
                                                                                  Alternative to traditional partner referral
    Alternative: Cefixime* 400 mg PO single dose PLUS
                                                                                  ◦ evidence-based data shows better outcomes
     Azithromycin 1gm single dose or doxy 100mg BID
                                                                                  Use for chlamydia, gonorrhea or trich infections
Other cephalosporins can be used but are either more expensive or less            Legal in most states, including Wisconsin
     efficacious and are not recommended for routine use. See 2010 guidelines
     for full discussion of alternatives.                                         ◦ law provides liability protection for provider
Azithromycin alone as 2g single dose is not recommended due to GI distress and    ◦ can label Rx with the phrase “EPT” if no name
     emergence of resistance. Use only for patients with cephalosporin allergy.
*Cefixime is not effective for pharyngeal infection                               ◦ must provide information handout
                                                                                       www.dhs.wisconsin.gov/communicable/std/ept/ept.htm




    Non-specific urethritis (NSU/NGU)                                             Nonspecific Urethritis in Men
    More common than chlamydia or gonorrhea                                         Continuum of symptoms: mild urethral irritation
    Multiple etiologies, including sexually acquired                                – “doesn’t feel right” – to frank dysuria and
                                                                                    discharge
    adenovirus, HSV, trichomonas, anaerobes,
    enteric bacteria; also non-infectious causes                                    Dx: >4 WBC/hpf on Gram stain OR >10
    Mycoplasma genitalium                                                           WBC/hpf on initial-void urinalysis
     ◦   Causes 5-25% of NGU; maybe cervicitis, PID                                 Pearl: dysuria in young men is STI unless proven
     ◦   no commercial diagnostic tests yet available                               otherwise
     ◦   public health impact not clear                                             Treatment: azithromycin or doxycycline
     ◦   azithromycin more effective than doxycycline                               For recurrent or persistent symptoms, cover
     ◦   moxifloxacin for documented persistent infection                           both trich and M. genitalium (azith + metro)




    Trichomoniasis                                                                Bacterial Vaginosis
         Diagnostic tests                                                         Treat all symptomatic women
         ◦ several rapid tests are available, offer improved sensitivity          Treat all pregnant women (risk of PROM, preterm, etc)
           over vaginal wet prep                                                  ◦ But insufficient evidence to support routine screening in pregnancy
                                                                                  Single dose therapy is ineffective
         ◦ culture is definitive; PCR available, not FDA cleared
         Treatment                                                                Recommended regimens:
         ◦   Metronidazole 2 g PO single dose (preferred)                         ◦ Metronidazole 500 mg BID X 7 days
                                                                                  ◦ Metronidazole gel 0.75%, 5g qHS X 5 days
         ◦   Tinidazole 2 g PO single dose (preferred)                            ◦ Clindamycin cream 2%, 5g qHS X 7 days
         ◦   Metronidazole 500 mg PO BID X 7 days (alternative)
         ◦   Metronidazole gel is ineffective and not recommended                 Alternative regimens:                             new
                                                                                  ◦ Tinidazole 2g PO qd x 2d, or 1g PO qd x5d
         ◦   Rescreen women 3 mo post treatment                                   ◦ Clindamycin 300 mg PO BID X 7 days
                                                            new
                                                                                  ◦ Clindamycin ovules 100g intravaginally qHS X 3 days




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                                                                                                                                8B: STI Update




  Human Papillomavirus (HPV)                                                HPV Infection – Impact
                                                                            Most infections are asymptomatic, benign and self-
A universal, ubiquitous infection:
                                                                            limited
 Nearly all adults have had genital HPV infection by age 50                 ◦ about 10% of infections result in disease (dysplasia or warts)
 50% of young women have incident HPV infection within                      ◦ most of these clear spontaneously.
 4 years of coitarche                                                       ◦ persistent infection with high-risk HPV type is the concern
 27% of adults 18-25 have prevalent infection (NHANES                       But, annually:
 and others)                                                                ◦   ~1 million people develop genital warts
 77% of adult men in HIM study had prevalent or incident                    ◦   ~1 million women develop cervical dysplasia
 infection over 3 yr observation period (Giuliano et al,                    ◦   24,000 people develop HPV-associated cancers
 Lancet 2011)                                                               ◦   ~20 deaths per day in U.S. due to HPV




  HPV Vaccines                                                              HPV Vaccines, continued
 Bivalent (HPV2) protects against HPV 16/18 only
 ◦ approved for use in women only, ages10-25
                                                                                Both vaccines are very immunogenic (50X
 ◦ indication: cervical cancer and precursors
                                                                                natural infection)
 Quadrivalent (HPV4) protects against HPV                                       Duration of protection is at least 6 years, likely
 6/11/16/18                                                                     longer
 ◦ approved for use in women and men, ages 9-26                                 ~$150/dose X3; dosing is 0,1-2, and 6 months
 ◦ indications: cervical, vulvar, vaginal, anal cancers and precursors,         Insurance coverage
   plus genital wart protection in both men and women
                                                                                ◦   >90% of plans cover women
 Both are highly efficacious (>99%) in preventing                               ◦   ~60% of plans cover men
 CIN 2/3; quadrivalent vaccine also prevents genital                            ◦   Federal VFC program covers children age 9-18
 warts (>99%)
                                                                                ◦   Patient assistance plans available for uninsured




  HPV Vaccine - ACIP Recommendations                                      Genital Wart Treatment
                                                                                                         Treatment Options for Genital Warts
  Routine immunization of all girls at age 11-12,                         Genital wart treatment
  and catch up for all women through age 13-26                            is associated with:                                   Clearance
                                                                                                                                              Risk of
                                                                                                                                            Recurrence
                                                                                                         Treatment               Rate (%)       (%)
  (HPV4 or HPV2)                                                             considerable discomfort
                                                                                                         Cryotherapy             60–90        20–40
                                                                             high cost (rx, visits)
  Elective immunization for all men age 9-26                                                             Imiquimod               30–50          15
                                                                             embarrassment
  (HPV4 only) new                                                                                        Interferon              20–60          †
                                                                             lengthy duration of
  Give regardless of sexual history or cytology                              therapy
                                                                                                         Laser treatment         25–50         5–50

                                                                                                         Podofilox               45–80         5–30
  No need to prescreen                                                                                   Podophyllin resin       30–80        20–65

  Does not affect Pap screening frequency                                                                Surgical excision       35–70          20

                                                                                                         Trichloroacetic acid    50–80          35




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                                                                                                                                 8B: STI Update




Sinecatechins Ointment 15%
(Veregen)
                                                        new
                                                                         Genital Wart Regimens by Site
     Botanical, derived from green tea leaves                            Site               Recommended Method

     Mechanism of action unknown, possibly an                            External genital
                                                                                            Provider: Cryotherapy, TCA/BCA, podophyllin, surgery
                                                                                            Patient: Podofilox, imiquimod, sinecatecins
     antioxidant
                                                                         Vaginal            Cryotherapy or TCA/BCA
     FDA indication for genital/perianal warts
     Patient applied, TID X 16 weeks                                     Urethral           Cryotherapy or TCA/BCA


     Local reactions (dermatitis)                                        Perianal/anal      Cryotherapy or TCA/BCA or surgery

     Rx, ~ $300 /15g tube
                                                                         Cervical           Gyn consultation and biopsy to exclude HSIL




Genital Herpes Infection                                               Herpes Diagnostic Testing
     HSV-2 is a common cause of first episode genital herpes           • PCR is preferred for lesion diagnosis
     and causes almost all recurrent genital herpes
     HSV-1 is an increasingly important cause of first episode         • Serology is appropriate to:
     genital herpes but recurrences are infrequent                      o Confirm a clinical diagnosis or f/u on a negative culture
 ◦    HSV-1 accounts for as much as 70% of genital herpes infections    o Diagnose patients with atypical or unrecognized infection
      in some adolescent/young adult populations                        o Manage partners of persons with genital herpes
 ◦    Most of these are acquired from oral-genital contact              Others to consider for serology testing:
                                                                        o Persons presenting for STD evaluation, esp if multiple partners
                                                                        o Persons with HIV infection
     Important synergism between HIV and HSV
                                                                        o MSM at increased risk of HIV acquisition
 ◦    2-5x increased risk of HIV acquisition if HSV2+
                                                                       • Routine screening is not recommended




                                                                       Genital Herpes:
Treatment Options for Genital Herpes                                   2010 CDC Treatment Recommendations
                                                                       www.cdc.gov/std/treatment/
     Episodic therapy (preferred for HSV1)
                                                                        Acyclovir, famciclovir, valacyclovir are all therapeutically
     short course of treatment to manage symptoms only                  equivalent
     Suppressive therapy (preferred for HSV2)                           Differences in cost, dosing, convenience
     daily treatment suppresses viral activity                          Treat initial clinical episode for 7-10 days (sometimes
     ◦ initiate at time of diagnosis                                    need14-20 days), recurrences for 3-5 days
     ◦ reduce or eliminate recurrent symptoms                           Always offer suppressive therapy for new HSV2
     ◦ reduce risk of transmission to sexual partners                   diagnosis, benefit greatest in first year
     Episodic suppression                                               One new regimen added: famciclovir 500mg X1, then
                                                                        250mg BID X 2 days for recurrent episodes. new
     short term use to cover periods of concern: travel, exams, etc




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                                                                                                 8B: STI Update




Syphilis                                                 Syphilis
 Low incidence; most infections now occur in              Standard treatment unchanged
 MSM                                                       ◦ Penicillin G benzathine, 2.4 million units IM single
 Routine screening of MSM is important; HIV                  dose (Bicillin L-A®)
 co-infection is common                                    ◦ weekly X3 if duration is unknown or > 1 year
 Use PCR or dark field for suspicious lesions, if         Same tx regimen if HIV+, but monitor with
 available                                                serologic follow up more frequently (q 3
 Lumbar puncture needed if CNS signs, tertiary            months)
 syphilis, or serologic treatment failure (not            Azithromycin as alternative drug discouraged
 indicated for latent syphilis alone)




HIV testing and prevention                               What’s New in HIV Testing
 CDC recommendations for primary care:                     Antigen-antibody combo test
 ◦ Screen all sexually active adults at least once
                                                           Tests for both p24 antigen and HIV1/2 antibody
 ◦ Screen higher risk patients annually (eg, MSM)
                                                           ◦ p24 antigen peaks 1-3 weeks after infection
 Offer post-exposure prophylaxis for significant           ◦ antibody detectable 4-6 weeks after infection
 exposures (occupational or non-occupational)
                                                           Positive result does not distinguish early vs late
 ◦ 28 day course of HAART, eg Truvada
                                                           ◦ need Western blot to confirm
 ◦ See MMWR 2005;54(RR-2) for details
                                                           ◦ If blot negative, then HIV RNA/pDNA needed
 ◦ Use national PEP hotline 800-448-4911
                                                           Improves sensitivity of screening test by ~2
 Recognize acute HIV/seroconversion illness
                                                           weeks
 ◦ Unexplained febrile illness in MSM          HIV PCR




Other STDs – Skin                                        Other STDs – Hepatitis
Molluscum contagiosum                                    Hepatitis A
◦ very common, not in guidelines
                                                         ◦  risk with performing oral sex, esp MSM
◦ umbilicated papules, esp lower
  abdomen, groin                                         ◦ immunize all adolescents and others at risk, MSM
◦ treat with cryo; topicals ineffective                  Hepatitis B
                                                         ◦ immunize everyone,
Scabies
                                                         ◦ screen MSM if not immunized prior to sexual activity
 high index of suspicion if systemic itching + rash
 skin scraping confirms but doesn’t rule out             Hepatitis C
 treament: permethrin 5% cream or ivermectin po          ◦ sexual transmission inefficient unless HIV or syphilis
 treat partners empirically                                co-infection; screen if HIV+ or history of IDU




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                                                                                                         8B: STI Update




STD 2010 Treatment Guidelines
Summary – Key Changes to Remember
                                                          Quiz
Chlamydia                                                    Kim, age 20, is seen for a routine contraception
◦ screen early, screen often, screen again (after tx)        visit. She has had 3 male partners in the last
Gonorrhea                                                    year. What STI tests would you order her for?
◦ ceftriaxone preferred over cefixime
◦ ceftriaxone dose is now 250mg IM                               Chlamydia
◦ add coverage for chlamydia (azith or doxy) to all              Gonorrhea
HPV                                                              HIV
◦ vaccinate adolescents and young adults,     and                Syphilis
Trich                                                            Pap smear
◦ Rescreen women 3 months post-treatment




Quiz                                                    STD Resources
                                                        American Social Health Association (ASHA):
  Kim’s exam is normal. Her test results are             brochures, books, newsletters (800) 230-6039
  negative for CT and HIV, but GC is positive.
                                                         national herpes hotline     (919) 361-8488
  Which of the following regimens is                     www.ashastd.org
  recommended for treatment of gonorrhea?
  ◦   Cefixime 400mg PO alone                           Other Web Resources:
  ◦   Ciprofloxacin 500mg PO alone                       www.cdc.gov/std/treatment -- STD Treatment Guidelines
  ◦   Ceftriaxone 125 or 250mg IM alone                   www.stdhivtraining.org/clinical_resources.html -- comprehensive
  ◦   Ceftriaxone 250mg IM + Azithromycin 1g PO           clinical resources from California STD Training Center

                                                        Craig Roberts, PA-C, MS cmroberts@uhs.wisc.edu     608-262-6720




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                                                                                                        8B: STI Update


                                                                                                         1 WEST WILSON STREET
                                                                                                                   P O BOX 2659
Jim Doyle                                                                                                MADISON WI 53701-2659
Governor
                                                    State of Wisconsin                                             608-266-1251
Karen E. Timberlake                                                                                           FAX: 608-267-2832
Secretary                                                                                                     TTY: 888-701-1253
                                              Department of Health Services                                   dhs.wisconsin.gov



            Date:        June 3, 2010

            To:          Wisconsin Health Care Providers and Pharmacists, Local and Tribal Public Health Officials

            From:        Tony Wade, Director, STD Control Section, Division of Public Health

                         Seth Foldy, MD, MPH, FAAFP
                         State Health Officer and Administrator, Division of Public Health

            Subject:     New STD Partner Management Strategy Available

            On May 11, 2010 Governor Doyle signed into law Senate Bill 460 (2009 Wisconsin Act 280) for
            expedited partner therapy (EPT) which is effective as of May 26, 2010. The new legislation explicitly
            allows medical providers to prescribe, dispense, or furnish medication to partners of patients diagnosed
            with trichomoniasis, gonorrhea, or Chlamydia trachomatis infection without a medical evaluation of the
            partner. This alternative sexually transmitted disease (STD) partner management strategy is called
            expedited partner therapy (EPT) and is recommended by the Centers for Disease Control and Prevention
            (CDC) to prevent persistent or re-current infection when other management strategies are impractical or
            unsuccessful.

            Specific changes made in the new law:
               1. Explicitly allows physicians, physician assistants, and certified nurse prescribers to dispense,
                    furnish, or prescribe medication for EPT and pharmacists to dispense medication for EPT;
               2. Limits liability for medical providers and pharmacists as long as EPT is provided in accordance
                    with the Act;
               3. Allows the prescription to be written in the partner’s name (preferred) or with “Expedited Partner
                    Therapy” or “EPT” in place of a name when the patient does not know or is unwilling to give the
                    partner’s name;
               4. Requires written materials be developed by the Department of Health Services and be distributed
                    to the patient by the medical provider, for use by the partner(s) receiving EPT. The information
                    sheet will contain facts about trichomoniasis, gonorrhea and Chlamydia trachomatis infection,
                    their treatment and the risk of drug allergies, as well as contact information for questions. The
                    information sheet must be distributed by the medical provider, along with the EPT medication or
                    prescription, in order for the provider to be in compliance with the Act.

            Tools for Implementation:
            A copy of the Act is currently posted and the EPT information sheets and guidance for providers,
            pharmacists, and local health providers will be available soon at
            http://dhs.wisconsin.gov/communicable/STD/EPT/EPT.htm. Also see www.cdc.gov/std/ept for further
            information regarding EPT.

            Act 280 does not change statutory requirements for reporting or follow-up of STDs.

                    Please contact the STD Control Program at (608) 266-7365 if you have any questions.



                                                        Wisconsin.gov                                                             10
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             Expedited Partner Therapy (EPT) Frequently Asked Questions Sheet, 2010

Q: Who is eligible for EPT?
A: The partner of a patient with a laboratory confirmed or suspected clinical diagnosis of Chlamydia
trachomatis infection, gonorrhea or trichomoniasis and who is unable or unlikely to seek timely clinical
services, and risks reinfecting the original patient, infecting others, and developing complications.

Q: What are the treatment (medication and dose) recommendations for EPT?
A: Partners exposed to patients diagnosed with chlamydia, but not gonorrhea:
   • Azithromycin (Zithromax) 1 gram (500 mg tablets x 2) orally once
   Partners exposed to patients diagnosed with gonorrhea, but not chlamydia:
   • Cefixime (Suprax) 400 mg orally once
   Partners exposed to patients diagnosed with both gonorrhea and chlamydia:
   • Cefixime (Suprax) 400 mg orally once, PLUS Azithromycin (Zithromax) 1 gram (500 mg tablets x
       2) orally once
   Partners exposed to patients diagnosed with trichomoniasis:
   • Metronidazole (Flagyl) 2-grams orally in a single dose

   Note: These are the recommended treatment regimens for EPT by DHS and the CDC. Please
   consult with the current CDC STD Treatment Guidelines
   (http://www.cdc.gov/std/treatment/2006/toc.htm) for alternative treatment regimens.

Q: Is there a limit on the number of doses or prescriptions that can be given to a patient?
A: DHS recommends that providers disburse the number of doses or prescriptions for the number of
known, locatable sex partners in the previous 60 days or most recent sex partner if none in the previous
60 days.

Q: Who pays for the partner’s medication?
A: The original patient’s (index patient’s) insurance cannot be billed for the partner’s medication (unless
the partner is covered on the patient’s insurance and the partner information is known). There is
currently no state funding to pay for EPT medication. Sex partners are responsible to pay for their own
medication where a fee is charged and/or use their own insurance to pay for a prescription.

Q: Can local health departments provide medication for the partners?
A: If a local health department has services/protocol to dispense medication (i.e. through an STD or FP
clinic) they may dispense, or furnish the EPT medication and/or prescriptions to the original patient for
his or her sex partners.

Q: Do providers have to use the treatment information sheets created by DHS?
A: No. While the statute states that a treatment Information Sheet must be provided to the original
patient with the EPT medication or prescription for his or her sex partners, providers have the choice of
using the DHS Information Sheets or one they have created/revised. The DHS treatment Information
Sheet can be revised for specific clinics/clinicians or they can create their own treatment information
sheet as long as it includes information required by statute, including information about STDs and their
treatment, the risk of drug allergies from the treatment, and a statement advising persons with questions
to contact his/her physician, pharmacist, or local health department for further questions. In all
situations, the patient must be given, per statute, a treatment information sheet for each partner who will
receive EPT (medication or prescription.)

Q: How should expedited partner therapy be entered into electronic medical records?
A: Since all electronic medical record systems differ, it is up to each entity to develop their own protocol
as to how they want to handle EPT in their patient’s electronic medical record.


For other questions or further information please see the provider guidance and other materials provided
by DHS at http://www.dhs.wisconsin.gov/communicable/STD/EPT/EPT.htm or call the DHS STD Section
at (608)266-7365.
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                                                                                           8B: STI Update

                        Summary of STI Screening Recommendations

                                     General Considerations


   1. Screening is defined as testing in the absence of symptoms. Clients with symptoms should be
      evaluated and tested based on clinical suspicion for specific etiologies.

   2. A sexual risk assessment is critical for determining STI/HIV risk and sites exposed. Only those
      clients who report sexual activity should be screened for STIs. Women who identify as lesbian or
      bisexual may be at risk for STIs from male sex partners.

   3. For chlamydia and gonorrhea, only those anatomic sites exposed should be screened. Nucleic
      acid amplification tests (NAATs) are recommended for screening. In addition to endocervical and
      urethral swab specimens, NAATs can be used with self-collected vaginal swabs and first-void
      urine specimens. Urine tests are preferred for men. For rectal and pharyngeal testing, NAATs are
      superior to culture and preferred for testing these sites.

   4. All clients who report exposure to an STI should be treated presumptively as indicated and tested
      for STI/HIV as determined by risk.

   5. All clients who are diagnosed with an acute STI should be tested for other STIs they may be at
      risk for, including HIV.

   6. Considerations for STI screening include the specific etiology, patient characteristics (gender,
      age, behavioral and other risk factors), sites of exposure, and frequency of testing. These
      recommendations are guided by the epidemiology of STIs and other research. Where there are
      no recommendations because of lack of data, clinicians should use their discretion in ordering
      appropriate tests.

   7. Patients should be told what they are being tested for…and what they are not being tested for.

   8. Testing based on client request should be considered since risk may not be disclosed.

   9. In general, the frequency of testing is based on interim risk. Thus, the time frame for assessing
      the need for screening based on reported risk factors is “since the last STI test”.

   10. Initial screening in pregnancy should occur at the first prenatal visit. Repeat testing may be
       indicated based on ongoing risk.




                      These guidelines represent a distillation of current evidence-
                      based recommendations published by CDC, the U.S.
                      Preventive Services Task Force, and other organizations.
                      The focus is on STI screening in young adult populations.




Craig Roberts, PA-C              University Health Services                                      Jan 2011
                                                                                                            12
                                                                                                 2011 APN Conference
                                                                                                 8B: STI Update

           Summary of STI Screening Recommendations: Disease Based

                                    CHLAMYDIA (Ct NAAT)


Screen all sexually active women under age 25

Screening should be done at any reproductive health visit
   • Strong evidence-based recommendation for screening women under age 25 annually
   • Insufficient evidence to recommend routine screening for men, but should be considered in
      clinical settings where prevalence is higher (adolescent clinics, STD clinics, MSM)
   • Genital specimens should be tested using a nucleic acid amplification test (NAAT)
   • Patients who report recent receptive anal intercourse can be tested with rectal NAAT or culture
   • Pharyngeal testing is not recommended for men or women
   • Self-collected vaginal swabs are the preferred test specimen for women. A first-void urine may
      also be used when a pelvic exam is not otherwise needed. Urine testing is preferred for men.
   • Rescreen infected women and men three months after treatment

In low prevalence settings (<1%), or women age >25, selective screening criteria may be used:
       -   patient had more than one partner in the previous 90 days, or
       -   patient had a partner with more than one partner in the previous 90 days, or
       -   patient had a new partner in the last 90 days, or
       -   patient had chlamydia or gonorrhea infection in the previous 5 years, or
       -   patient had a partner with symptoms consistent with or diagnosis of chlamydia including urethritis,
           epididymitis, cervicitis, or PID, within the past 90 days, or
       -   patient had a partner with diagnosis of other STIs in the past 90 days (GC, syphilis, trich)



                                   GONORRHEA (Gc NAAT)

Screen persons at increased risk for gonorrhea.

Risk is not well defined, but includes:
   • Women under age 25 with multiple partners and inconsistent condom use
   • Men who have sex with men (MSM); test all relevant anatomic sites – genital, pharyngeal, rectal
   • High community prevalence of gonorrhea or high incidence in a patient’s sexual network
   • Commercial sex work and exchanging drugs for sex
   • Diagnosis of other STIs, particularly previous gonorrhea infection
   • Patient’s partner has symptoms or diagnosis of another STI

Do not screen men or women who are at low risk of infection.

In low risk adults the incidence of gonorrhea is very low (<1%) and routine screening of these patients,
including women under age 25, may not be not justified. Local prevalence and risk factors should be
considered. African-Americans have a higher incidence of infection overall but rates vary by geographic
area. Some experts recommend using race/ethnicity as a risk criteria.

Genital specimens should be tested using a nucleic acid amplification test (NAAT). Urine is preferred for
men and may be done for women. Use NAAT (preferred) or culture for other sites.

Rescreen women three months after treatment.

Craig Roberts, PA-C               University Health Services                                            Jan 2011
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                                                                                             2011 APN Conference
                                                                                             8B: STI Update


                                    HEPATITIS B (HbsAg)


Screen for hepatitis B surface antigen in persons at increased risk for infection:
   • Men who have sex with men
   • Injection drug users, past or current
   • Persons born in geographic areas with an increased prevalence of hepatitis B (>2%)
   • Sexual partners of persons with chronic hepatitis B infection
   • Persons with liver disease of unknown cause (persistently elevated ALT), hemodialysis patients,
      pregnant women, persons with HIV infection.

Do not screen persons who are not at increased risk.

Previously immunized persons do not need screening unless they were at risk prior to receiving vaccine.
If so, screen once to rule out chronic infection. Transmission of hepatitis B occurs by both sexual and
percutaneous routes.


                             HEPATITIS C (HCV antibody EIA)


Screen for hepatitis C antibody in persons with known risk factors for this infection:
   • Injection drug use, past or current
   • Persons who received a transfusion, transplant or blood products prior to 1992
   • Persons with liver disease of unknown cause (persistently elevated ALT)
   • HIV-infected MSM

Do not screen persons who are not at increased risk.

Transmission of hepatitis C is mostly percutaneous; sexual transmission is infrequent.


                           HERPES (HSV-2 gG antibody ELISA)


Routine screening for herpes in adults or adolescents is not recommended.

Some organizations and experts recommend that providers consider screening persons at higher risk of
having genital herpes including:
   • Sexual partners of persons with known genital herpes infection
   • Men who have sex with men, if at increased risk of HIV acquisition
   • Persons with HIV infection
   • Persons with multiple partners and higher risk sexual behaviors

HSV prevalence increases with age and the number of lifetime sexual partners. Testing is more useful
when the prior probability of having herpes is high. The prevalence of HSV-2 in young adults under age
25 is less than 10%; the positive predictive value of a type-specific antibody test in this age group is low.
Equivocal results should be repeated using a alternate test and/or confirmed by Western blot.

Screening should be done using only type-specific (glycoprotein G based) serologic tests. There is no
value for IgM testing.


Craig Roberts, PA-C              University Health Services                                        Jan 2011
                                                                                                                14
                                                                                         2011 APN Conference
                                                                                         8B: STI Update


                                HIV (HIV 1/2 antibody EIA)


Screen all sexually active adolescents and adults for HIV antibody.

Persons at increased risk should be screened annually:
   • Men who have sex with men
   • Injection drug users
   • Persons exchanging sex for money or drugs
   • Persons who have had multiple sex partners since their most recent HIV test
   • Sexual partners of any of these patients

CDC recommends HIV testing for all patients seeking treatment for an STD regardless of known or
suspected risk. Reactive antibody tests must be confirmed by Western blot.


                      HUMAN PAPILLOMAVIRUS (High Risk HPV DNA)

Routine screening of adults for HPV infection is not recommended.

Per ASCCP Guidelines, a high-risk HPV DNA test may be used as an adjunct to cervical cytology in
women age 30 and older. This test is not approved for screening use in women under age 30.


                                SYPHILIS (RPR OR VDRL)


Screen women and men who are at increased risk for syphilis:
   • Men who have sex with men
   • Injection drug users
   • Persons exchanging sex for money or drugs
   • Sexual partners of any of these patients

Screen pregnant women at the first prenatal visit

Do not screen men or women who are not at increased risk

The prevalence of syphilis in adolescents and young adults is very low (<1%); routine screening is
probably not justified except for MSM. Local prevalence and risk factors should be considered. A reactive
screening test must be confirmed with the TP-PA test or equivalent.


                          TRICHOMONIASIS (Wet Prep or PCR)


No recommendation

There are no published recommendations regarding screening of asymptomatic women or men for
trichomoniasis. Incidence is estimated to be high but varies by population. Local prevalence and risk
factors should be considered. Women with infection should be re-screened 3 months after treatment.


Craig Roberts, PA-C             University Health Services                                     Jan 2011
                                                                                                            15
                                                                                             2011 APN Conference
                                                                                             8B: STI Update

           Summary of STI Screening Recommendations: Patient Based


                                         ALL PATIENTS


Obtain a basic sexual history to include
   • Partners: # partners last 90 days and gender of those partners
   • Practices: sites of sexual contact (oral, genital, vaginal, anal), injection drug use
   • Protection: frequency of condom use
   • Past History: previous STDs
   • Prevention of Pregnancy: contraception use if pregnancy not desired

Genital exam to assess for lesions/warts (optional)


                         WOMEN WITH MALE PARTNERS (WSM)

Chlamydia NAAT (cervical swab, first void urine, or self-collected vaginal swab)
Gonorrhea NAAT, if increased risk (cervical swab, first void urine, or self-collected vaginal swab)
HIV antibody (if not previously tested, or recent risk factors)
Syphilis (VDRL or RPR) only if at increased risk


                          MEN WITH FEMALE PARTNERS (MSW)


Chlamydia NAAT (first void urine)
Gonorrhea NAAT, if increased risk (first void urine)
HIV antibody (if not previously tested, or recent risk factors)
Syphilis (VDRL or RPR) only if at increased risk



                       WOMEN WITH FEMALE PARTNERS (WSW)

Chlamydia and gonorrhea NAAT (cervical or urine) if history of male partners
Syphilis and HIV antibody tests if at increased risk (male partners, IDU)



                           MEN WITH MALE PARTNERS (MSM)

Chlamydia and Gonorrhea NAAT (first void urine)
Chlamydia and Gonorrhea NAAT or culture (rectal) if recent receptive anal intercourse
Gonorrhea NAAT or culture (pharynx)
Syphilis serology (RPR or VDRL)
HIV antibody test
Hepatitis B surface antigen (if not immunized prior to onset of sexual activity)




Craig Roberts, PA-C               University Health Services                                      Jan 2011
                                                                                                             16
                                                                                            2011 APN Conference
                                                                                            8B: STI Update

          Summary of STI Screening Recommendations: Patient Based


                                    PREGNANT WOMEN

At the first prenatal visit, or as soon as possible, all women should be screened for these STIs:

Chlamydia NAAT; repeat in third trimester if at increased risk (age <25 or multiple partners)
HIV antibody test
Hepatitis B (HbsAg)
Syphilis (VDRL or RPR)

If risk factors are present, pregnant women should also be screened for these STIs:

Gonorrhea NAAT, if at risk or in community or sexual network with high prevalence. Repeat in third
    trimester if ongoing risk during pregnancy
Hepatitis C, if at high risk (see standard risk criteria)
Bacterial vaginosis: consider evaluation for women at increase risk for preterm labor; there is insufficient
evidence to assess the balance of benefit vs. harm for screening this population

See CDC STD Treatment Guidelines for a full discussion of testing issues in pregnant women




Craig Roberts, PA-C              University Health Services                                         Jan 2011
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                                                                                                2011 APN Conference
                                                                                                8B: STI Update

References (topic area highlighted)
United States Preventive Services Task Force. USPSTF Recommendations for STI Screening. Am Fam Phys
2008;77(6):819-24.

Guide to Clinical Preventive Services, 2008. Recommendations of the U.S. Preventive Services Task Force.
Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/pocketgd.htm

Meyers DS et al. Screening for Chlamydia Infection: An Evidence Update for the U.S. Preventive Services Task
Force. Ann Intern Med 2007;147:135-42.

CDC. Male Chlamydia Screening Consultation – Meeting Report May 22, 2007. Available online at:
http://www.cdc.gov/std/chlamydia/ChlamydiaScreening-males.pdf

CDC. Screening Tests to Detect Chlamydia trachomatis and Neisseria gonorrhoeae Infections-2002. MMWR
2002;51(rr15):1-38.

Maloney SK, Johnson C. Why Screen for Chlamydia? An Implementation Guide for Healthcare Providers.
Partnership for Prevention, Washington DC. 2008. Available online at http://www.prevent.org/templates/ncc-
home/download/whyscreenforchlamydia.pdf

California Chlamydia Action Coalition. Chlamydia Screening & Treatment Practice Guidelines, 2002. Available
online at: http://www.igh.org/castd/downloadable/clinicalpractice_guidelines.pdf

CDC. Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B
Virus Infection MMWR 2008;57 (No. RR–8).

CDC. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care
Settings. MMWR 2006;55(No. RR-14).

Bartlett JG et al. Opt-Out Testing for Human Immunodeficiency Virus in the United States: Progress and
Challenges. JAMA 2008;300(8):945-951.

CDC. Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related
Chronic Disease. MMWR 1998;47(No. RR-19).

Handsfield HH. Resurgent Sexually Transmitted Diseases Among Men Who Have Sex With Men: Screening
Guidelines for STD/HIV Prevention. Medscape Infectious Diseases 2001;3(2). Available at:
http://www.medscape.com/viewarticle/408301

Gunn RA, O’Brien CJ, Lee MA, Gilchick RA. Gonorrhea Screening Among Men Who Have Sex With Men: Value
of Multiple Anatomic Site Testing, San Diego, California, 1997-2003. Sex Trans Dis 2008;35(10):845:48.

Buffington J, et al. Low Prevalence of Hepatitis C Virus Antibody in Men Who Have Sex with Men Who Do Not
Inject Drugs. Pub Health Reports 2007;122(S2):63-67.

Guery SL et al. Recommendations for the Selective Use of Herpes Simplex Virus Type 2 Serologic Tests. Clin
Infect Dis 2005;40(1):38-45.

Hayley DM et al. Performance of Focus ELISA Tests for HSV-1 and HSV-2 Antibodies Among University Students
With No History of Genital Herpes. Sex Trans Dis 2007;34(9):681-85.

CDC. 2006 Disease Profile [A review of STD, HIV/AIDS, hepatitis and TB surveillance data]. Available at
http://www.cdc.gov/nchhstp/Publications/docs/2006_Disease_Profile_508_FINAL.pdf




Craig Roberts, PA-C                University Health Services                                         Jan 2011
                                                                                                                 18
                                                                                         2011 APN Conference
                                                                                         8B: STI Update

Resources

Sexually Transmitted Diseases Treatment Guidelines, 2010.
Standard reference guide for STD treatment from the Centers for Disease Control and Prevention
www.cdc.gov/std/treatment/

National Center for HIV/STD/TB Prevention, Division of STD Prevention
Primary CDC portal site for STD information, for providers and patients
www.cdc.gov/std/

California Chlamydia Action Coalition
Comprehensive site with links to resources and guidelines. Includes a downloadable cost-effectiveness
program to determine costs and benefits of chlamydia screening in managed care organizations.
www.ucsf.edu/castd/chlamydia_coalition.html

CDC National Prevention Information Network
STD Resource page of NPIN, a service of the National Center for HIV, STD and TB Prevention at
CDC. Links to databases, publications and other resources.
www.cdcnpin.org/std/start.htm

Summary Guidelines for the Use of Herpes Simples Virus (HSV) Type 2 Serologies
Useful guide covering herpes screening from the California STD Controllers Association
www.stdhivtraining.org

STD Checkup – Screen, Diagnose, Treat, & Prevent: A Clinician’s Resource for STDs in Gay Men
and Other MSM
California Dept of Public Health site with recommendations, protocols, guidelines, patient materials.
www.stdcheckup.org/provider/index.html

CDC - Infertility Prevention Project
Major CDC initiative focused on screening and treatment of chlamydia and gonorrhea. Provides funding
for testing programs in many family planning clinics. Source for state and regional chlamydia data.
www.cdc.gov/std/infertility/ipp.htm

National Chlamydia Coalition
CDC-sponsored coalition of non-profit organizations, professional associations, advocacy groups, and
government representatives dedicated to elevating the importance of chlamydia screening and
treatment. Website includes screening toolkit, policy guidelines, patient and provider resources.
www.prevent.org/NCC.

American Social Health Association
Nonprofit organization dedicated to preventing STDs. Quality patient resources and materials.
www.ashastd.org

Cincinnati STD/HIV Training Center
CDC Region V (upper Midwest) designated site for provider training. Offers health professionals a
spectrum of educational opportunities to increase knowledge and skills in the areas of sexual and
reproductive health. Classroom, clinic and distance learning options.
http://www.stdptc.uc.edu/




Craig Roberts, PA-C            University Health Services                                     Jan 2011
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