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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?
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