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

Summary

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.

Timeline

Start

2025-10-29

Primary completion

2028-10-31

Completion

2029-04-30

Publications

• Ochieng F, Wambua P, Kimani J, Wanjiru M, Agingu W, Kabuti R, Mdletshe N, McKinnon LR, Otieno FO, Mehta SD. Prevalence of and Factors Associated With Urethral and Rectal STIs Among a Cross-Sectional Sample Men Who Have Sex With Men. Sex Transm Dis. 2026 Jul 1;53(7):435-443. doi: 10.1097/OLQ.0000000000002320. Epub 2026 Mar 24.
• Graham SM, Otieno FO, Kimani J, Barrientos A, Soge OO, Sharma M, Hamilton DT, Celum C, McClelland RS, Sanders EJ. World Health Organization-Recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for Sexually Transmitted Infection Control Among Men Who Have Sex With Men in Kenya: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 6;15:e81113. doi: 10.2196/81113.

Drugs

Indications