PrEP, short for pre-exposure prophylaxis, is a daily, orally administered pill that is highly effective at preventing HIV. Despite an increase in the number of individuals initiating the use of PrEP globally, it still remains inaccessible to many individuals living in sub-Saharan African countries. “Barriers exist with clinic-based models of HIV PrEP service delivery (e.g., stigma, long wait times) in Kenya and many other similar African countries. Thus, differentiated models of PrEP service delivery that can vary the WHO, WHAT, WHERE and WHEN of how services are delivered are needed,” explained Dr. Katrina Ortblad, an Assistant Professor in the Public Health Sciences Division at Fred Hutch, who recently led two studies testing novel models of PrEP service delivery.
In the first of these studies, published in the Journal of the International Aids Society, Dr. Ortblad and colleagues focused on the variation in “where”: they tested a novel model of PrEP service delivery at private, community-based pharmacies, which are commonly utilized as the first point of healthcare access in many low-income countries. PrEP is currently delivered at a limited number of public healthcare clinics dedicated to the delivery of HIV services in Kenya, but some clients are hindered by the stigma associated with visiting HIV clinics, limited clinic hours, and long travel distances to and wait times at the clinics. This single-arm (i.e., no control or placebo group), prospective pilot evaluation was conducted at five private pharmacies in Kiambu and Kisumu Counties in Kenya from November 2020 to December 2021.
Interested clients first underwent a behavioral risk assessment and counseling to determine PrEP eligibility, then a medical safety assessment to ensure that they did not have medical conditions that could contraindicate PrEP safety, such as kidney disease. (Clients who reported these conditions, as well as pregnant and breastfeeding women, were referred to clinic-delivered PrEP services.) Eligible clients who tested HIV negative were dispensed a 1-month supply of daily oral PrEP and scheduled for follow-up visits 1 month later. At the follow-up visits, clients who continued to meet the screening criteria received a 3-month PrEP supply. Pharmacies, who received the HIV testing and PrEP commodities for free, charged clients 300 Kenyan shillings (~$3 USD) for each visit.
The researchers found that PrEP initiation and continuation at private pharmacies were comparable to, or exceeded, those at public HIV healthcare clinics. Additionally, clients perceived pharmacy-delivered PrEP services as both highly acceptable and appropriate, and were willing to pay for pharmacy-delivered PrEP services. “Surprisingly, men older than 25 years (a population that is often challenging to reach) had the greatest PrEP continuation in the model of pharmacy-delivered PrEP services,” said Dr. Ortblad. Young women, a priority population for the delivery of HIV prevention services, often acquire HIV from their older male partners. Thus, making PrEP service delivery accessible to this demographic is important for reducing HIV incidence.
In the second study, published in JAMA Network Open, Dr. Ortblad and colleagues examined the consequences of the variation in “when.” “We tested a novel model of PrEP service delivery that reduced that number of PrEP clinic visits in half with 6-month PrEP dispensing supported with interim HIV self-testing,” said Dr. Ortblad. The standard of care is 3-month PrEP dispensing, with HIV testing at the quarterly clinic visits.
Researchers recruited 495 PrEP clients who were returning for a follow-up visit. The clients included men and women in HIV serodifferent couples and singly enrolled women. The researchers randomized the participants to one of two intervention groups, or to a control standard-of-care group. Those in the intervention group received either an oral- or blood-based HIV self-testing kit and 6-month PrEP dispensing, while the control group was dispensed 3 months of PrEP and scheduled for quarterly clinic visits.
After 12 months, the researchers measured three outcomes of PrEP continuation: HIV testing, PrEP refilling, and PrEP adherence. “We found that semiannual PrEP dispensing simplified PrEP delivery without jeopardizing client-level PrEP continuation outcomes,” said Dr. Ortblad. “Surprisingly, the model of semiannual PrEP dispensing significantly increased PrEP adherence among a subgroup of women not in known HIV serodifferent couples.”
Dr. Ortblad and colleagues are already following up on the results from both studies. “Our team just launched a 60-pharmacy, 4-arm cluster-randomized controlled trial with funding from the Bill and Melinda Gates Foundation to test different cost-sharing models that can inform the scale up and sustainability of pharmacy-delivered PrEP services in Kenya and similar settings,” said Dr. Ortblad. “The study testing a model of 6-month PrEP dispensing was an individual-level randomized trial conducted at one research clinic. Next, our team is hoping to test this model of PrEP service delivery in real-world public clinics in a cluster-randomized controlled trial to help inform scale up of the model in Kenya and similar settings.”
This work was supported by the National Institute of Mental Health.
The Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium members Drs. Katrina Ortblad and Nelly Mugo contributed to this work.
Ortblad KF, Mogere P, Omollo V, Kuo AP, Asewe M, Gakuo S, Roche S, Mugambi M, Mugambi ML, Stergachis A, Odoyo J, Bukusi EA, Ngure K, Baeten JM. 2023. Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation. J Int AIDS Soc. 26(6):e26131.
Ortblad KF, Bardon AR, Mogere P, Kiptinness C, Gakuo S, Mbaire S, Thomas KK, Mugo NR, Baeten JM, Ngure K. 2023. Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial. JAMA Netw Open. 6(6):e2318590.