Offering STI testing to boost PrEP use during and after pregnancy
Official title: Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model
Run by Botswana Harvard AIDS Institute Partnership · NCT06919614 · Data updated 2026-11-12
This trial will test whether offering STI testing together with PrEP options helps pregnant women in Botswana start and keep using PrEP during pregnancy and up to 9 months after delivery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | Botswana Harvard AIDS Institute Partnership Academic / other |
| Locations | 1 site (Gaborone) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2029 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT06919614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant cisgender women without HIV who are not currently using PrEP, seeking antenatal care at participating Botswana clinics, and planning to remain in the area through 9 months postpartum are ideal candidates.
✕Probably not a fit
People living with HIV, current PrEP users, non-pregnant individuals, men, or those unable to remain in the enrollment area until 9 months postpartum are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a two-arm, 1:1 randomized design, 600 pregnant cisgender women without HIV attending antenatal clinics in Gaborone will be assigned to either standard syndromic STI management or to receive molecular testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using Xpert assays alongside PrEP offer. Participants will be offered a choice of oral PrEP pills or the dapivirine vaginal ring and may start, stop, or switch methods during follow-up. Primary outcomes include PrEP initiation, persistence at 9 months postpartum, and adherence measured by hair drug levels, with secondary outcomes including PrEP choice, STI rates, and birth outcomes. Participants will be followed through 9 months postpartum with exploratory endpoints including HIV incidence, quality of care, adherence cofactors, and surveillance for antimicrobial resistance.
Why it matters
Potential benefit: If successful, adding STI testing to PrEP services could increase PrEP uptake and persistence among pregnant women, lowering HIV risk for mothers and their infants.
How similar studies have gone: While PrEP delivery in pregnancy and STI screening individually have established benefits, combining routine molecular STI testing with PrEP offers in a randomized trial is relatively novel in pregnancy settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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DHMT Clinics
Gaborone, Botswana Recruiting
Study contacts
- Study coordinator: Chelsea Morroni, MBChB, DFSRH, MPH, PhD
- Email: chelseaamorroni@gmail.com
- Phone: +267 316 6657
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.