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Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Sponsor: University of Washington
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.
Official title: WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya
Key Details
Gender
MALE
Age Range
18 Years - 29 Years
Study Type
INTERVENTIONAL
Enrollment
2900
Start Date
2025-10-29
Completion Date
2029-04-30
Last Updated
2025-11-19
Healthy Volunteers
Yes
Interventions
WHO-recommended periodic presumptive treatment
400 mg po cefixime plus 1 gram azithromycin po under direct observation
Doxycycline post-exposure prophylaxis
200 mg po doxycycline within 24-72 hours after condomless anal or vaginal sex as frequently as daily
Locations (3)
Anza Mapema Clinic
Kisumu, Kenya
University of Washington/Pwani Research Centre at the Ganjoni Municipal Clinic, Mombasa
Mombasa, Kenya
TRANSFORM Clinic
Nairobi, Kenya