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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

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Bob Kirkcaldy, Nicholas Gaffga, Lori Newman

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

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

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

  4. 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 womenattending STD clinics - Demographic characteristics? Behavioral characteristics? Vary by site? • Sensitivity of wet preps (vs InPouch culture)

  5. 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

  6. 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?

  7. 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

  8. Data Flow With TRICH # Local trich clinical dataset Positive Culture Specimen Trich clinical data transmitted CDC lab (Evan) Trich lab data Merged trich dataset - CDC TRICH # MLC Results sent to sites AGE MLC TRICH # Optional inclusion of TRICH #

  9. 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?

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

  11. 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

  12. 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?

  13. 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

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