HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya

BackgroundThe introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya.MethodsThe JiPime-JiPrEP (Kiswahili for Test Yourself, PrEP Yourself') study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n=495) are eligible for enrollment if they are at least 18years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n=165) and women (n=165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n=165) who areat HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for theobjective measurement of PrEP adherence at baseline, 6months, and 12months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6months and secondarily at 12months.DiscussionThe findings from this trial can help to understand how HIVST-a new HIV-1 testingtechnology-can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya.Trial registrationClinicalTrials.gov, NCT03593629. Retrospectively registered on 20 July 2018.