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

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.

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	2025-10-29
Primary Completion	2028-10-31 (estimated)
Study Completion	2029-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-19