NIH R01 MH113572, MPIs: JM Baeten (UW), K Ngure (JKUAT)
Project Directors: P Mogere (PHRD), K Ortblad (UW)
Oral pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective and being scaled up at public health facilities throughout sub-Saharan Africa. However, barriers to facility-based PrEP delivery, such as frequent (quarterly) facility visits and high opportunity costs for clients, remain. Simplified models of PrEP delivery that improve efficiencies without jeopardizing client outcomes are needed in this setting. In a randomized non-inferiority implementation trial, we tested a model of 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) at 3 months to reduce the number of PrEP facility visits in half. Eligible participants were ≥18 years old and had taken PrEP for one month. We randomized participants 2:1 to: 1) 6-month PrEP dispensing (with semiannual healthcare facility visits, supported with HIVST at three months) or 2) standard-of-care PrEP delivery (three-month PrEP dispensing with quarterly facility visits), Fig 1. Our primary outcomes, measured at 6 months, were HIV testing (any testing between enrollment and the 6-month visit), PrEP refilling, and PrEP adherence (any detectable tenofovir-diphosphate in dried blood spots). This trial was conducted from May 2018 to February 2020, and the primary findings were recently published in the Lancet HIV (Ngure et al, 2022).
^Ortblad mentee or team member
BMGF INV-033052, PI: K Ortblad (Hutch); Kenyan PIs: E Bukusi (KEMRI), K Ngure (JKUAT)
Project Director: D Were (Jhpiego); Project Coordinators: B Kwach (KEMRI)
HIV self-testing (HIVST) could be a powerful tool to increase the efficiency and feasibility of delivering PrEP in private pharmacies by reducing the time pharmacy providers spend serving PrEP clients, thus freeing them up to serve other pharmacy clients. However, due to concerns around both the sensitivity of HIVST kits to detect early infection and individuals’ ability to correctly interpret HIVST results, neither the World Health Organization nor the Kenya Ministry of Health currently recommend using HIVST for PrEP prescribing or dispensing. In this HIVST performance study, which was carried out at 20 private pharmacies in Kisumu County, Kenya, we compared the performance of blood-based (BB) HIVST conducted by clients (with provider assistance available upon request) to rapid diagnostic testing conducted by an HIV Testing Service (HTS) counselor, which is the standard of care for PrEP prescribing/dispensing in Kenya, Fig. 2. The findings from this study will help us understand the potential use of BB HIVST as a tool to increase efficiencies in models of pharmacy-delivered PrEP services and the potential of HIVST to support other models of community-delivered PrEP services (e.g., online delivery).
WHO 2022/1223615-0 PI: K Ortblad (Hutch)
Project Director: C Kiptinness (PHRD)
HIVST has the potential to simplify models of PrEP delivery, potentially expanding access to and uptake of PrEP services to those in need. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. After screening 1,055 records, we included eight: 3 randomized trials and 5 values and preferences studies. None measured PrEP initiation. Most studies occurred in sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly healthcare facility visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly healthcare facility visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.
^Ortblad mentee or team member
JKUAT: Jomo Kenyatta University
KEMRI: Kenya Medical Research Institute
PHRD: Partners in Health & Research Development
UW: University of Washington