1. Bob Kirkcaldy, Nicholas Gaffga, Lori Newman
SSuN Cycle 2 Conference call January 22, SSuN 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 antibiotic resistance
- 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 women attending STD clinics
Sensitivity of wet preps (vs InPouch culture)
Simplify or delete slide

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 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
Summarize agreed upon protocol to date – frame it as the in-place, unless active objections emerge
40 from symptomatic

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 Local trich clinical dataset Trich clinical data transmitted
With TRICH #
Local trich clinical dataset
PT ID #
AGE
RACE/ETHN
TRICH #
WET PREP SX
OTHER VARS
Positive Culture Specimen
Trich clinical data transmitted
TRICH#
AGE
RACE/ETHN
WET PREP SX
OTHER VARS
CDC lab (Evan)
Trich lab data
Merged trich dataset - CDC
TRICH #
MLC
TRICH#
AGE
RACE/ETHN
WET PREP SX
OTHER VARS
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. Variables for Trich Dataset: Core & Standardized
# Male, Female partners
Commercial sex work
Drug Use
Condom with last sex?
Anonymous sex?
Education?
Student?
Employment?
Age
Race/Ethnicity
Sexual orientation
Pregnancy
HIV status, history
Diagnostic codes
Lab results

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