Determining the timing of Chlamydia trachomatis test of cure Sarah K Tillman, MD Gweneth Lazenby, MD MSCR MUSC Obstetrics and Gynecology

Chlamydia Trachomatis 3 rd most common STI in US Risk factors Impact of estrogen & progesterone Center for Disease Control and Prevention, 2014 Hall et all Cell Microbiology Kauschi et al Immunology

Complications and Screening Center for Disease Control and Prevention, 2014

Previous Research 79% negative at Day 14 – 3-4 day intervals until 14 days following treatment – Multiple linear regression analysis 100% = 17 days Presence of Chlamydia DNA or rRNA up to 51 days Renault et al Sex Health Dukers-Muijrers et al PLOSone

Objective Determine the time to negative Chlamydia NAAT following therapy in pregnant and non- pregnant women Determine if pregnancy affects the time to clearance of infection Recommend test of cure timing in pregnant and non-pregnant women

Sample Size Calculation Survival Analysis Assumptions Pregnant women will take 7 days longer to clear Chlamydia infection Accrual time: 21 days Power 80% Alpha 0.05 Sample size: 33 pregnant and 33 non-pregnant subjects

Methods Participation Complete Negative test Patient notified Participation Complete Negative test Patient notified Weekly Visits Chlamydia NAAT Survey Condoms Weekly Visits Chlamydia NAAT Survey Condoms First Visit Consent BV gram stain Trich NAAT Survey Condoms Compensation Chlamydia Tx First Visit Consent BV gram stain Trich NAAT Survey Condoms Compensation Chlamydia Tx Enrollment Eligibility Screening + test

Data Analysis Survival analysis – Event = negative TOC – Use Log Rank test to compare the time to negative TOC in pregnant and non-pregnant women with Chlamydia Continuous variables -> t-test – Age of sexual debut -> Wilcoxon rank-sum test Categorical variables -> Fisher's exact test

Results (Interim analysis) April 13, 2014 N = 37, study completion = 30 Mean age 24 60% pregnant (22) Median age of sexual debut 16 Median number of lifetime partners 5 68% report a history of an STI 14% are diagnosed with another STI at time of CT 35% are diagnosed with BV at initial visit

Results Pregnant n = 22Non-pregnant n = 15p-value Age23 (± 5)25 (± 4)0.2 Medicaid funded19 (86%)6 (40%)0.005 Age of sexual debut16 (13-25)16 (12-22)0.7 Lifetime sexual partners 4 (1-10)6 (3-50)0.07 History of STI18 (82%)7 (47%)0.04 BV at enrollment6 (27%)7 (47%)0.2 Another STI at enrollment 4 (18%)1 (7%)0.6 Loss to follow up5 (24%)2 (13%)0.7 Days until negative16 (± 13)10 (±4)0.2

Results Log-rank test p value = 0.2

Conclusions Recruitment ongoing… – 38 enrolled thus far (66 needed) Average 4/month 23% loss to follow-up rate Expected study completion: April 2015 – Study advertising – Informative handout at screening

Acknowledgements Dr. Lazenby Dr. Pierce Tamara Pfeffer, research coordinator