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

Katrina F Ortblad, John E Kearney, Kenneth Mugwanya, Elizabeth M Irungu, Jessica E Haberer, Ruanne V Barnabas, Deborah Donnell, Nelly Rwamba Mugo, Jared M Baeten, Kenneth Ngure, Katrina F Ortblad, John E Kearney, Kenneth Mugwanya, Elizabeth M Irungu, Jessica E Haberer, Ruanne V Barnabas, Deborah Donnell, Nelly Rwamba Mugo, Jared M Baeten, Kenneth Ngure

Abstract

Background: The 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.

Methods: The 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 18 years 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 are at 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 the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months.

Discussion: The findings from this trial can help to understand how HIVST-a new HIV-1 testing technology-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 registration: ClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018.

Keywords: Delivery models; HIV-1 self-testing; HIV-1 serodiscordant couples; HIV-1 testing; Kenya; PrEP; Randomized trial; Young women.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of study enrollment, randomization, and intervention arms. Note that all participants will receive HIV-1 counseling, condoms, and sexually transmitted infection management at clinic visits. HIVST HIV-1 self-testing, neg negative, PrEP pre-exposure prophylaxis.
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments for the JiPime-JiPrEP randomized trial. *Only participants randomized to the standard-of-care arm have visits at months 3 and 9. ENR enrollment, M month, PrEP pre-exposure prophylaxis

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