NCT06919614

STI Testing to Enhance PrEP Use in Pregnancy

Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Botswana Harvard AIDS Institute Partnership · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

The investigators are conducting a 2-arm 1:1 randomized trial to compare PrEP delivery with co-offer of STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (using Xpert CT/NG and TV assays) vs. standard-of-care (SOC, syndromic management) among pregnant women without HIV (n=600) in Botswana. Antenatal care clients will be offered PrEP (self-select oral pills or DPV-VR). Participants will be followed up to 9 months postpartum. Women will be able to switch PrEP methods and start, stop, or restart PrEP at any time. Primary outcomes are the proportion of clients who initiate PrEP, persist with use at 9 months postpartum, and adhere (quantified by hair drug levels). Secondary outcomes are PrEP choice (pills vs. DPV-VR), STI rates, and birth outcomes by randomization arm. Exploratory outcomes are HIV incidence, quality of care, adherence cofactors, and antimicrobial resistance.

Conditions

• PrEP Adherence
• Sexually Transmitted Infections (STIs)
• Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing	Xpert® CT/NG and TV testing

Timeline

• Start date: 2025-06-18
• Primary completion: 2027-08-31
• Completion: 2029-08-31
• First posted: 2025-04-09
• Last updated: 2025-07-29

Locations

1 site across 1 country: Botswana