Study of Integrated STI Testing to Support PrEP Use During and After Pregnancy in Botswana

What this Trial Is About

Researchers are conducting a study in Botswana to see if offering testing for sexually transmitted infections STIs along with expanded HIV prevention options, specifically pre-exposure prophylaxis PrEP, helps more pregnant women start and continue using PrEP during pregnancy and after giving birth. The study involves 600 pregnant women without HIV who are seeking antenatal care. The purpose is to compare the usual care, which includes standard STI assessment without testing, to an approach that includes STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Participants are randomly assigned to one of two groups the intervention group receives STI testing using Xpert CTNG and TV assays during pregnancy and postpartum at three time points enrollment, 32 weeks gestation, and 9 months after delivery or two time points if enrolled in the third trimester. Women in this group learn to self-collect vaginal swabs. The standard care group receives STI symptom assessment per national guidelines during pregnancy and STI testing only at 9 months postpartum. All women are offered PrEP and can choose between oral pills or a dapivirine vaginal ring, with the option to start, stop, or switch methods at any time. Participants are followed through pregnancy and up to nine months after delivery. The study includes regular monitoring of PrEP use, including initiation, continued use, and adherence measured by drug levels in hair samples. Other assessments include STI rates, choice of PrEP method, birth outcomes, HIV incidence, quality of care, factors influencing adherence, and antimicrobial resistance. The total duration of participation includes antenatal care and postpartum follow-up visits.

STI Testing to Enhance PrEP Use in Pregnancy