Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Status:
NOT_YET_RECRUITING
Trial end date:
2029-04-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
University of Washington
Collaborators:
Aurum Institute National Institute of Allergy and Infectious Diseases (NIAID) Nyanza Reproductive Health Society Partners for Health and Development in Africa