Comparing WHO Periodic Presumptive Treatment and Doxycycline Post-Exposure Prophylaxis for STI Control in Kenyan Men Who Have Sex With Men Aged 18 to 29

What this Trial Is About

Men who have sex with men MSM in Kenya face a high risk of gonorrhea, chlamydia, and syphilis, but testing for these infections is often not available, resulting in many cases going undiagnosed. This research investigates the impact and cost-effectiveness of two WHO-recommended treatmentsperiodic presumptive treatment PPT given every 3 months and doxycycline post-exposure prophylaxis doxyPEP taken after condomless sexcompared to standard symptom-based treatment. The study aims to understand how these approaches affect infection rates and antibiotic resistance in Neisseria gonorrhoeae among Kenyan MSM. The trial will randomly assign 2900 participants to one of three groups in a 221 ratio the PPT group receiving cefixime and azithromycin every 3 months if eligible, the doxyPEP group receiving doxycycline to take within 24-72 hours after condomless sex, and the standard care group receiving symptom-based treatment at each visit. Participants will be followed for 18 months, with regular assessments every 3 months at clinics designed to support MSM. During the study, participants will undergo screenings for sexually transmitted infections and receive treatment as per their assigned group. Researchers will monitor infections of gonorrhea, chlamydia, and early syphilis using culture-based and molecular tests. The study will collect data on adherence, safety, and acceptability of the treatments, and use findings to model the potential health and economic benefits of wider use of these strategies in Kenya and similar settings. The total participation period is 18 months with quarterly visits to track infection outcomes and antibiotic resistance.

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