Clinical Trial

STI Testing to Enhance PrEP Use in Pregnancy

Study acronym: STEP-UP
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-02; most recent amendment 2026-06-09.
Status change: Not Yet Recruiting → Recruiting 2025-07-27
Trial Details
NCT Number NCT06919614
Lead Sponsor Botswana Harvard AIDS Institute Partnership
Collaborators: University of Washington, University of Botswana
Conditions PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
Enrollment 600 participants
Start Date 2025-06-18
Primary Completion 2027-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-11