MPrEP+ study protocol: a prospective cohort study assessing the feasibility and acceptability of an HIV pre-exposure prophylaxis (PrEP) strategy for male clients of female sex workers in Kisumu, Kenya

INTRODUCTION: Male clients (MCs) are integral to sex work-driven HIV transmission dynamics as sexual partners of female sex worker (FSW). MCs contribute disproportionately to incident HIV globally and in sub-Saharan Africa, with 27% of new infections attributed to MCs of FSW and other partners of key populations. Gaps in coverage of HIV testing and prevention services for men, including MCs, are well-documented, yet research and innovative interventions to improve MC uptake of effective prevention services, including pre-exposure prophylaxis (PrEP), are scarce. METHODS AND ANALYSIS: MPrEP+ is a cohort study designed to assess the feasibility and acceptability of a PrEP-focused HIV prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with three adherence self-management interventions: (1) use of a validated point-of-care urine drug-level assay with real-time feedback and tailored self-management counselling; (2) frequent HIV self-testing; and (3) weekly one-way text messaging. This package of interventions is being delivered to 120 MCs enrolled in the study in Kisumu, Kenya over a 6-month period. The primary outcome is PrEP adherence at 6 months as measured by PrEP drug levels. Bivariate and multivariable regression models will be used to identify predictors of PrEP adherence. We will also explore associations of sociodemographic characteristics and PrEP beliefs with PrEP adherence. ETHICS AND DISSEMINATION: The study was approved by the Columbia University Irving Medical Center Institutional Review Board and the Maseno University Ethical Review Committee. Study enrolment was initiated in November 2021 with participant follow-up planned through August 2022. Study results will be submitted for publication in peer-reviewed journals. Summaries and infographics of study findings will be developed and distributed to MC, FSW and stakeholders working in HIV prevention and support for people who sell and buy sex, including Kenya’s Ministry of Health. TRIAL REGISTRATION NUMBER: NCT04898699; Registered on 24 May 2021.