ssun cycle 2 conference call january 22, 2009 ssun part b laboratory component: trichomonas...
TRANSCRIPT
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SSuN Cycle 2Conference call
January 22, 2009
SSuN Part B Laboratory Component: Trichomonas Resistance Assessment
Bob Kirkcaldy, Nicholas Gaffga, Lori Newman
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Agenda
Administrative topics Trichomonas resistance activity
• Review protocol• Discuss data flow• Variables
Discuss future Part B activities
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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
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• 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
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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
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• 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
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• 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
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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 #
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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?
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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?
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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
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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?
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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