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

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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3521-2) contains supplementary material, which is available to authorized users.

The current landscape of pre-exposure prophylaxis service delivery models for HIV prevention: a scoping review

“…Five articles had a focus on the combination of MSM and TGW [45][46][47][48][49]. One study focused exclusively on TGW [50], one on female sex workers (FSW) [51], one on men and women in a serodiscordant relationship [52], one on pregnant or postpartum women [53] and one study focused exclusively on youth (11-24 years old) at risk of HIV acquisition [54]. See Figure 3 for an overview of the different PrEP service delivery model components in the included literature.…”

“…In high-resource settings, PrEP was more likely to be delivered in such specialised clinics, in particular in USA, Belgium, Scotland, England, Australia, New Zealand and Canada [22,23,24,27,29,31,34,38,40]. In reports from Kenya, Zimbabwe and Table 1 (see end of manuscript) should be positioned here in the main text South Africa, specialised clinics were mentioned as part of the existing facilities used to scale-up the provision of PrEP [25,28,32,37,52]. The policy reports from the latter three African countries were the only identi ed records offering a nation-wide implementation plan for PrEP [25,28,37].…”

“…Three articles described how people could receive home-based PrEP services, by performing parts of PrEPrelated care themselves. This could include sampling for STIs and/or HIV testing [41,52]. Clients and providers could engage in counseling services over the phone or through videoconference [42].…”

“…Delivery channels were understood as platforms or media that were used to deliver PrEP services to the people. In most of the articles, PrEP care was provided through a 'traditional' face-to-face setting, meaning PrEP clients attended in-person to a service provider in a given physical setting [22][23][24][25][26][27][28][29][31][32][33][34][35][36][37][38]40,44,47,[49][50][51][52][53][54].…”

“…At the other end, a completely home-based PrEP care model emerged, where PrEP users were not required to leave their house to continue on PrEP regimens [41,42]. In between these two ends, models were described whereby one or more in-person visits were replaced by tele-visits or home-based self-care [30,48,52].…”