WHO-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 (Preprint)

BACKGROUND Men who have sex with men (MSM) are at high risk for gonorrhea and chlamydia in Kenya, where nucleic acid amplification testing is not widely accessible and most infections therefore go undiagnosed. WHO-recommended periodic presumptive treatment (PPT) and doxycycline post-exposure prophylaxis (doxyPEP) are both potential interventions to reduce the burden of bacterial sexually transmitted infections (STI) in this population. Neither has been rigorously tested among MSM in Africa. OBJECTIVE To evaluate the effectiveness of WHO-recommended PPT versus doxyPEP, compared to standard syndromic treatment, at reducing the prevalence of bacterial STI including gonorrhea, chlamydia and syphilis, among MSM in Kenya. METHODS We will conduct an open-label randomized clinical trial with 2900 participants assigned in a 2:2:1 ratio to WHO-recommended PPT given every 3 months, doxyPEP taken 24-72 hours after condomless sex, or standard syndromic treatment. Participants will be followed quarterly over 18 months. Samples testing positive for Neisseria gonorrhoeae will undergo rigorous culture-based and molecular analysis of antimicrobial resistance. Over the course of the trial, we will assess the acceptability, feasibility, and safety of each intervention compared to standard care among providers and patients. RESULTS Results of this trial will provide critical data needed to inform guidelines to improve STI control among MSM in sub-Saharan Africa and other resource-limited settings where testing is not routinely available. Trial data will be used to model the health and economic impact of scaling up WHO-recommended PPT and doxyPEP compared to standard care on STI control among MSM and their partners in Kenya using a stochastic, agent-based model and cost-effectiveness evaluation. Modelled estimates of the health and economic impact of scaling up these two interventions on STI control among MSM and their partners in Kenya will provide critical information to guide policymakers. CONCLUSIONS 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. CLINICALTRIAL ClinicalTrials.gov NCT06468462