1. SSuN Cycle 2 SSuN Part B Laboratory Component: Trichomonas Resistance Evaluation Bob Kirkcaldy, Lori Newman, Kristen Mahle December 4, 2008

2. Agenda Overview, objectives, potential questions New York City: Lessons Learned Proposed Methodology Review of current SSuN STD clinic screening and testing practices Specimen collection and transport * Break * Data Elements Data use and dissemination Human subjects review considerations

3. SSuN Laboratory Component Objectives To establish a network of STD clinics with high quality laboratory and clinical capacity to implement a broad range of STD surveillance activities First Part B activity: trichomonas resistance Future activities Depend on public health importance and availability of funding

4. Trichomonas Resistance Activity Objectives To improve control of Trichomonas vaginalis infection through: - 1 o : Identifying the prevalence of in vitro antibiotic resistance in this population - 2 o : Describing the prevalence, sociodemographic, and clinical characteristics of women with T. vaginalis infection attending STD clinics

5. What is the prevalence of trichomoniasis in women attending STD clinics? - Does it vary by region? Age? Race/ethnicity? HIV status? Other variables? What is the prevalence of T. vaginalis resistance in this population? - Does it vary by population? - Is there a relationship between symptoms and in vitro findings? - Does resistance differ for wet prep(+) vs. wet prep(-)? - What is the local sensitivity of wet preps (compared to InPouch TV culture)? - Is there an association with resistance and recent antibiotic use or recent treatment for trich? Potential Trichomonas Resistance Analytic Questions

6. Trichomonas Resistance Activity: Proposed Methodology Goal: Each site to send 60 positive trich cultures to CDC per year for susceptibility testing ~ 10-20% expected to die in transport ► 50 viable cxs/year Include all women attending sentinel STD clinics who undergo a speculum exam, including Asymptomatic those without discharge on exam wet prep negative Wet prep and inoculation of InPouch for all women Treat women based on wet prep and culture results

7. Send InPouch to local laboratory for culture Send all positive T. vaginalis cultures to CDC for aerobic susceptibility testing Metronidazole and tinidazole Trichomonas Resistance Monitoring: Proposed Methodology

8. Information from SSuN STD clinics Estimated number of speculum exams performed per week What are standard practices for trich screening in asymptomatic women or women without vaginal discharge? Do any clinics currently culture for trich and in what situations? What treatment regimen is used for trichomonas infection?

9. Logistical Sampling Considerations Specimen Collection and Transport CDC cannot accept specimens on weekend For large volume sites: Collection on Thursdays & Fridays? Ship overnight express to CDC on Mondays & Tuesdays? Transfer culture specimens to allow batching of shipments? Local lab culture storage constraints? CDC lab capacity limitations (~15-20/week) How to stagger specimen collection/transport to avoid overload Need to send Coinfection information? What specimen collection/transport processes will work in participating clinics?

10. Current Trichomonas Volume in SSuN Sites

11. Variables for Trichomonas Resistance Activity Patient ID Date of visit Visit Type Age Race/Ethnicity Sexual Orientation Pregnancy County or other localization data HIV status Crude STD symptom variable Diagnostic codes Lab results Trich history BV history Trich-Specific symptoms Discharge or Odor or Itching Physical exam findings Vaginal discharge Core STD Clinic VariablesTrich-specific Variables

12. Data Dissemination Mechanism for returning susceptibility results to the site

13. Human Subjects Review Considerations  Is the proposed methodology still surveillance?  Will participant consent be needed?