Men who have sex with men (MSM) are at high risk for gonorrhea and chlamydia in Kenya, where nucleic acid
amplification testing (NAAT) is not feasible and most infections therefore go undiagnosed. While development
of low-cost point-of-care diagnostics is an urgent priority, low-cost and feasible interventions to control sexually
transmitted infections (STI) among MSM are needed now, as we await technology advance. In 2011, the WHO
recommended periodic presumptive treatment (PPT) of Neisseria gonorrhoeae (NG) and Chlamydia
trachomatis (CT) infections for MSM at high risk for HIV acquisition due to condomless anal intercourse with
multiple sex partners or a recent STI exposure. More recently, trials in well-resourced settings have
demonstrated the efficacy of doxycycline post-exposure prophylaxis (doxyPEP) at reducing NG, CT, and
syphilis infections among high-risk MSM. In this R01 application, we propose a rigorous study to evaluate the
impact and cost-effectiveness of WHO-recommended PPT versus doxyPEP, compared to standard syndromic
treatment, among Kenyan MSM. Our highly productive research team, including collaborators from the
University of Washington, Aurum Institute, Nyanza Reproductive Health Society, and Partners for Health and
Development in Africa, has expertise in clinical STI care, epidemiology, research with MSM populations, and
intervention trials (MPI Graham and Sanders, co-Is Otieno and Kimani), NG and CT diagnosis and testing for
antimicrobial resistance (AMR) (co-I Soge), infectious disease modeling (co-I Hamilton), and costing of
interventions (co-I Sharma). This study aims to (1) evaluate the effectiveness and impact on AMR in NG of two
interventions: WHO-recommended PPT given every 3 months and doxy-PEP taken 24-72 hours after
condomless sex, compared to standard syndromic treatment, for reducing STI burden among Kenyan MSM;
(2) assess the acceptability, feasibility, and safety of implementing WHO-recommended PPT and doxy-PEP
compared to standard care among providers and patients; and (3) model the health and economic impact of
scaling up WHO-recommended STI PPT and doxyPEP compared to standard of care on STI control among
MSM and their partners in Kenya. We will conduct an open-label randomized clinical trial with 2900 participants
to evaluate these two interventions versus the standard of care assigned in a 2:2:1 ratio, with 18 months of
follow-up and rigorous culture-based and molecular analysis of AMR in NG at three MSM-friendly research
clinics in Kenya. We will use multidisciplinary science to measure the acceptability, feasibility, and safety of
these two interventions, using a conceptual model based on Proctor’s Implementation Science Framework.
Finally, Aim 1 and 2 results will inform parameters to update a stochastic model of STI transmission and cost-
effectiveness analysis to project the impact of scaled-up STI PPT and doxyPEP in Kenya. This work will
provide the critical data needed to inform guidelines and improve STI control among these key populations in
sub-Saharan Africa and other resource-limited settings.
