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

SSuN Cycle 2Conference 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

• 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- Demographic characteristics? Behavioral

characteristics? Vary by site? - Sensitivity of wet preps (vs InPouch culture)

Potential Analytic Questions

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

• 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:Population

• 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

Trichomonas Resistance: Lab Methodology

Data Flow

PT ID #

AGE RACE/ETHN

TRICH #

WET PREP

SX OTHER VARS

TRICH#

AGE RACE/ETHN

WET PREP

SX OTHER VARS

TRICH#

AGE RACE/ETHN

WET PREP

SX OTHER VARS

MLC

TRICH # MLC

Positive Culture Specimen

CDC lab (Evan)

Trich lab data

Local trich clinical dataset

Trich clinical data transmitted

Merged trich dataset - CDC

TRICH #

Optional inclusion of TRICH # MLCAGE

Results sent to sites

With 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

• Age• Race/Ethnicity• Sexual orientation• Pregnancy• HIV status, history• Diagnostic codes• Lab results

• # Male, Female partners• Commercial sex work• Drug Use• Condom with last sex?• Anonymous sex?• Education?• Student?• Employment?

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