SSuN Cycle 2

SSuN Part B Laboratory Component: Trichomonas Resistance Evaluation

Bob Kirkcaldy, Lori Newman, Kristen Mahle

December 4, 2008

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

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

Trichomonas Resistance Activity Objectives

• To improve control of Trichomonas vaginalis infection through:

- 1o: Identifying the prevalence of in vitro antibiotic resistance in this population

- 2o: Describing the prevalence, sociodemographic, and clinical characteristics of women with T. vaginalis infection attending STD clinics

• 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 ResistanceAnalytic Questions

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

• 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

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?

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?

Current Trichomonas Volume in SSuN Sites

Site Year collected

Specimen Test

# positives

Prevalence Notes

Birmingham Est. annual

Culture ~1700 25% Estimation of # cases based on research data of 25% prevalence; ~ 6 cases/day (=1700/260); ~30 cases/week

DMHC, Denver 2007 ? 224 ~0.9 cases/day (=224/260); ~4.5 cases/week

NYC 2006 Wet mount

~600 All BSTDC clinics, ~2.3 cases/day for all clinics, ~11.5 cases/week

NYC 2008 Culture 17/110 15% One clinic, January 1 – April 16, 2008, ~0.2 cases/days (=17/75 business days); ~ 1 case/week

San Francisco City Clinic

2006 ? 88 82 (93%) diagnosed among women; 82 cases /260 days = 0.3 cases/day; ~1.5 cases/week

DHC # 1 Philadelphia

2006 Wet mount

630 630/260 = 2.4 cases/day = ~12 cases/week

DHC # 1 Philadelphia

2007 Wet mount

774

Harborview, Seattle

2007 ? 116 116/260 = 0.45 cases/day = ~2 cases/week

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 Variables Trich-specific Variables

Data Dissemination

• Mechanism for returning susceptibility results to the site

Human Subjects Review Considerations

Is the proposed methodology still surveillance?

Will participant consent be needed?