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Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Sep 1, 2025 to Oct 29, 2025 · Collaborators revised (4)v5 Show 3 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 1, 2025 to Oct 29, 2025
    • Collaborators revised (4)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jan 31, 2028 to Oct 31, 2028 Start date: May 1, 2025 to Sep 1, 2025 · Completion date: Jul 30, 2028 to Apr 30, 2029v4 Show 2 more changesShow less
    • Start date: May 1, 2025 to Sep 1, 2025
    • Completion date: Jul 30, 2028 to Apr 30, 2029
  3. Start date: Dec 1, 2024 to May 1, 2025v3
  4. Start date: Aug 1, 2024 to Dec 1, 2024 Eligibility criteria shortened, about 7 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Men who have sex with men (MSM) are at high risk for gonorrhea and chlamydia in Kenya, where nucleic acid amplification testing is not feasible and most infections therefore go undiagnosed. We propose an open-label randomized clinical trial with 2900 participants assigned to WHO-recommended periodic presumptive treatment (PPT) or doxycycline post-exposure prophylaxis (doxyPEP), compared to standard syndromic treatment, with 18 months of follow-up and rigorous culture-based and molecular analysis of antimicrobial resistance in Neisseria gonorrhoeae. This work will provide critical data needed to inform guidelines and improve STI control among MSM in sub-Saharan Africa and other resource-limited settings, including modelled estimates of the health and economic impact of scaling up these two interventions on STI control among MSM and their partners in Kenya.
Trial Details
NCT Number NCT06468462
Lead Sponsor University of Washington
Collaborators: Aurum Institute, Nyanza Reproductive Health Society, National Institute of Allergy and Infectious Diseases (NIAID), Partners for Health & Development in Africa
Conditions Gonorrhea Male, Chlamydia (Male), Syphilis Male
Enrollment 2,900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov