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STI Testing to Enhance PrEP Use in Pregnancy

Study acronym: STEP-UP
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 31, 2027 to Aug 31, 2027
    • Study completion date: Dec 31, 2027 to Aug 31, 2029
    • Site details revised
    v3
  3. Interventions: Chlamydia, gonorrhoea and trichomonas testing (Diagnostic Test) to Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing (Diagnostic Test)
    • Study description expanded, about 9 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06919614
Lead Sponsor Botswana Harvard AIDS Institute Partnership
Collaborators: University of Washington, University of Botswana
Conditions
(from sponsor)		 PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
Related terms Chlamydia Infections, Gonorrhea, Sexually Transmitted Diseases, Trichomonas Infections
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov