Bob Kirkcaldy, Nicholas Gaffga, Lori Newman SSuN Cycle 2 Conference call January 22, 2009 SSuN Part B Laboratory Component: Trichomonas Resistance Assessment Bob Kirkcaldy, Nicholas Gaffga, Lori Newman

Agenda Administrative topics Trichomonas resistance activity Review protocol Discuss data flow Variables Discuss future Part B activities

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

Potential Analytic Questions Prevalence of T. vaginalis resistance in women attending STD clinics - Demographic characteristics? Behavioral characteristics? Vary by site? - Relationship between symptoms and in vitro findings Relationship between wet prep results and in vitro findings Relationship between prior TV history and in vitro findings Prevalence of trichomoniasis among women attending STD clinics Sensitivity of wet preps (vs InPouch culture) Simplify or delete slide

Trichomonas Resistance: Collection Methodology Each site to send 50 viable trich cultures to CDC for susceptibility testing ~10-20% expected to die in transport ► ~60 cultures sent ► ~50 viable cultures Staggered initiation of collection CDC can only accept 15-20 specimens/wk Sites can use collection pattern of choice Every day vs. set days per week Schedule to be determined Wet prep and inoculation of InPouch for all included women Summarize agreed upon protocol to date – frame it as the in-place, unless active objections emerge 40 from symptomatic

Trichomonas Resistance: Population Include all women attending sentinel STD clinics who undergo a speculum exam Asymptomatic and Symptomatic Seattle & SF: only symptomatic Others: At least 40 of 50 specimens/site from symptomatic women With and without discharge on exam Wet prep positive and negative Include women in Family Planning clinics? Treat women based on wet prep at time of visit Use culture results at follow-up visit?

Trichomonas Resistance: Lab Methodology Send InPouch to local laboratory for culture Local lab storage constraints? Send all positive T. vaginalis cultures overnight express to CDC for aerobic susceptibility testing CDC can only accept shipments Mon – Fri Avoid excessively cold temperatures If necessary, local labs can transfer specimens to new InPouch after 4-5 days to maintain viability of trichomonads before shipping CDC lab will conduct metronidazole and tinidazole susceptibility testing

Data Flow Local trich clinical dataset Trich clinical data transmitted With TRICH # Local trich clinical dataset PT ID # AGE RACE/ETHN TRICH # WET PREP SX OTHER VARS Positive Culture Specimen Trich clinical data transmitted TRICH# AGE RACE/ETHN WET PREP SX OTHER VARS CDC lab (Evan) Trich lab data Merged trich dataset - CDC TRICH # MLC TRICH# AGE RACE/ETHN WET PREP SX OTHER VARS MLC Results sent to sites AGE MLC TRICH # Optional inclusion of TRICH #

Data Flow Questions Trich data to be sent separately from core Only 6 sites participating, only small # patients Can de-identify data for sites that want this What periodicity of data transmission? How do sites want trich data returned to them? What data? What format? Who?

Variables for Trich Dataset: Core & Standardized # Male, Female partners Commercial sex work Drug Use Condom with last sex? Anonymous sex? Education? Student? Employment? Age Race/Ethnicity Sexual orientation Pregnancy HIV status, history Diagnostic codes Lab results

Variables for Trich Dataset: Trich-specific TRICH Number (site, date, specimen #) Trich history (self-report, medical record) BV history? (self-report, medical record) Trich-Specific symptoms Discharge, Odor, or Itching Vaginal discharge on Physical exam

Possible Future Part B Lab Activities Are we ready to start planning additional activities in Part B? What should they be? Does in vitro resistance correlate with clinical treatment failure? Other, non-trich topic?

Possible Future Part B Lab Activities HCV prevalence Acceptability, feasibility, and validity of genital self-sampling for HPV among men Prevalence of mycoplasma genitalium in MPC Etiology of NGU/NGNCU % of PID related to GC/CT Efficacy of treatment of 2 gram dose of Flagyl for trich Implementation of HSV2 point-of-care testing LGV prevalence Genetic diversity of trichomonas