STI Testing to Enhance PrEP Use in Pregnancy (NCT06919614) | Clinical Trial Compass
RecruitingPhase 3
STI Testing to Enhance PrEP Use in Pregnancy
Botswana600 participantsStarted 2025-06-18
Plain-language summary
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) versus STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis during pregnancy and postpartum. The investigators' hypothesis is that providing STI testing alongside PrEP offer will encourage more women to start and continue using PrEP.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant and seeking antenatal care
* Self-identifying as a cis-gender woman
* Living without HIV
* Not currently using PrEP
* Planning to remain in the city/town of enrolment until 9 months post-delivery.
* Planning to receive antenatal and postnatal care in the city/town of enrolment.
* Willing and able to provide informed consent
Exclusion Criteria:
* Male gender
* Not pregnant
* Living with HIV
* Currently using PrEP
* Not planning to remain in the city/town of enrolment until 9 months post-delivery
* Not planning to receive antenatal and postnatal care in the city/town to enrolment
* Not able or willing to provide informed consent for participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PrEP initiation among pregnant women seeking antenatal care
Timeframe: Enrolment to 1 month post enrolment
2
PrEP persistence
Timeframe: Enrolment to 9 months postpartum
3
PrEP adherence
Timeframe: Enrolment to 9 months postpartum
Trial details
NCT IDNCT06919614
SponsorBotswana Harvard AIDS Institute Partnership