Left: Dr. Laban standing outside his pharmacy 'MediHelp' in Kiambu County, Kenya. Right: Sanaa pharmacy in Juja, Kiambu County, Kenya.
Photos by Fred Hutch. All pharmacy providers gave us permission to use these images.08/01/19-06/30/21
NIH R34 MH120106, PI: K Ortblad (Hutch), Kenyan PIs: K Ngure (JKUAT), E Bukusi (KEMRI)
Project Directors: P Mogere (PHRD), V Omollo (KEMRI)
The delivery of HIV pre-exposure prophylaxis (PrEP) at private pharmacies has the potential to overcome barriers to facility-delivered PrEP services, including HIV-associated stigma, long wait times, and overcrowding. In collaboration with Kenyan stakeholders, we developed a model of private pharmacy-delivered PrEP services—one of the first of its kind to be implemented in Africa—that utilizes a standardized prescribing checklist to identify individuals at HIV risk without any medical conditions that might contraindicate PrEP safety and to guide PrEP dispensing (Fig. 1). In a one-arm intervention trial (ClinicalTrials.gov: NCT04558554), we pilot tested this model for 12 months (November 2019 to December 2021) at four pharmacies in Kiambu County (in central Kenya) and Kisumu County (in western Kenya) and measured PrEP initiation, continuation, and implementation outcomes, such as acceptability and cost.
Fig. 1. Care pathway for pharmacy-delivered PrEP services in Kenya (Ortblad KF, BMC Health Serv Res 2020).
01/31/21-7/31/21
BMGF INV-033052, PI: K Ortblad (Hutch); Kenyan PIs: K Ngure (JKUAT), E Bukusi (KEMRI)
Project Directors: D Were (Jhpiego), S Roche (Hutch); Project Coordinators: P Mogere (PHRD), V Omollo (KEMRI)
Following the initial Pharm PrEP Pilot Study, we modified the model of pharmacy-delivered PrEP services to address delivery challenges and potential missed opportunities. Specifically, we made one adaptation to the intervention (switching from oral fluid-based to blood-based HIV testing), and we incorporated six implementation strategies in an effort to improve PrEP uptake (Fig. 2). Beginning in January 2022, we implemented this model for six months in 12 pharmacies (six in Kiambu County and six in Kisumu County). Enrollment ended on July 31, 2022 and analysis is ongoing. In this study, we are measuring PrEP and PEP initiation, PrEP continuation, PEP-to-PrEP transition rate, PrEP adherence, as well as a number of implementation outcomes, including acceptability, feasibility, and cost.
Fig 2. Pharmacy PrEP Pilot Extension care pathway with new implementation strategies.
Fig. 3. The design of the Pharm PrEP cluster-randomized trial testing different economic incentives for pharmacy-delivered PrEP services.
01/01/22-11/14/25
BMGF INV-033052, PI: K Ortblad (Hutch); Kenyan PIs: E Bukusi (KEMRI), K Ngure (JKUAT)
Project Directors: D Were (Jhpiego), C Kiptinness (PHRD), V Omollo (KEMRI), S Roche (Hutch); Project Coordinators: T Kareithi (PHRD), K Harkey (Hutch)
Our formative research and pilot studies suggest that the success and sustainability of pharmacy-delivered PrEP services in Kenya will hinge, in part, on identifying a financial model in which pharmacy providers are sufficiently incentivized to deliver services and clients in need of PrEP services are able to afford services. In a hybrid cluster-randomized trial we will compare two different cost-sharing models and also compare each cost-sharing model to a control scenario in which pharmacies refer clients interested in PrEP to healthcare facilities (thus mimicking the current standard of care at private pharmacies in Kenya). Specifically, we will randomize 60 pharmacies spread across Nairobi, Kiambu, Kisumu, Homa Bay, Migori, and Siaya counties to one of four study arms: 1) pharmacy-delivered PrEP for a fee paid by clients at each visit; 2) pharmacy-delivered PrEP for free (at no costs to clients; per-visit fee paid by implementors); 3) pharmacy-delivered PrEP with an HIV Testing Services (HTS) counselor to assist with the more time-consuming parts of PrEP delivery (e.g., recruitment, counseling, and HIV testing; and 4] pharmacy provider referral to facility-based PrEP services (with pharmacies receiving a small incentive to screen and refer clients), (Fig. 3).
Our primary effectiveness outcomes will be PrEP initiation and continuation by 60 days. In secondary analyses, we will measure longer-term PrEP continuation outcomes (e.g., continuation by 270 days; stopping and restarting PrEP). We will also assess implementation outcomes, including acceptability, appropriateness, feasibility, and costs. We hypothesize that PrEP initiation and PrEP continuation at 60 days will be greater in private pharmacies that offer the service for free (at no cost to clients) compared to those that offer it for a fee paid by clients. We also anticipate that, regardless of whether clients pay a fee, capacitating pharmacy providers to deliver PrEP will result in greater PrEP initiation and continuation compared to a scenario where they refer clients seeking PrEP services to public health facilities.
Fig. 4. The design of the pharmacy-delivered PrEP refill model.
02/15/19-02/14/22
NIH P30 AI027757, PI: K Ortblad (Hutch), Kenyan PI: K Ngure (JKUAT)
Project Coordinators: A Kuo (UW), P Mogere (PHRD)
Compared to PrEP initiation, PrEP refilling is a less-complicated medical intervention; thus, we wanted to test a model of facility-based PrEP initiation in which clients had the option to refill their PrEP prescriptions at private pharmacies. Our goal was to understand preferences for PrEP refilling location within this client population and to assess the feasibility of pharmacy-delivered PrEP refills, for which pharmacy providers only needed to assess returning clients for potential PrEP side effects and HIV breakthrough infections. From November 2020 to December 2021, we tested this model (Fig. 4) in Kiambu County, Kenya at two public health facilities, each paired with a study pharmacy for the purposes of this study. Clients ≥18 years old who initiated PrEP at one of the two facilities were eligible to participate. Among those who initiated PrEP, we measured whether and where (healthcare facility or pharmacy) clients refilled PrEP at 1, 4 and 7 months and their preferred PrEP refill location. Additionally, we conducted qualitative interviews with clients who did not opt to refill their PrEP prescription at a private pharmacy to understand what drove this decision (e.g., considerations of cost, burden). The results of this study are forthcoming.
12/1/2022 – 11/30/2024
BMGF INV-041269, Co-PI: K Ortblad (Hutch), Kenyan Co-PI: E Bukusi (KEMRI), Site PIs: K Ngure (JKUAT), V Omollo (KEMRI)
Project Managers: R Malen (Hutch); Project Coordinators: T Kareithi (PHRD), K Harkey (Hutch)
New, long-acting (LA) forms of pre-exposure prophylaxis (PrEP) for HIV prevention—including the monthly dapivirine vaginal ring (DPV-VR] and bimonthly cabotegravir (CAB-LA) injections—are discreet, safe, and highly efficacious alternatives to daily oral PrEP. Early evidence suggests that prospective LA PrEP clients are interested in accessing these products at private pharmacies; however, little is known about whether and how LA PrEP could be feasibly implemented in this delivery setting. To identify potential barriers to implementing LA PrEP delivery in private pharmacies in Kenya and possible ways to address these, we conducted in-depth interviews with (1) current and former PrEP users, some of whom had prior experience accessing oral PrEP at private pharmacies (n=15) and some of whom had only ever accessed it at a public health facility (n=8); (2) pharmacy providers, some of whom had prior experience delivering oral PrEP at their pharmacy (n=8) and some without such experience (n=8); and (3) key stakeholders from PrEP policymaking and regulatory bodies, implementing organizations, and professional pharmacy associations (n=9). Interviewees discussed their interest in or support for the idea of private pharmacies delivering LA PrEP and identified gaps—for example, in policy, regulatory practices, and pharmacy provider competencies—that they felt would need to be addressed for this to become a reality in Kenya. Preliminary findings from this formative research were presented at a stakeholder meeting, held in Nairobi in September 2023. Meeting attendees discussed the identified barriers and potential solutions, provided feedback on a prototype care pathway for delivering LA PrEP at private pharmacies, and brainstormed next steps for generating evidence that could potentially inform future LA PrEP policy and roll-out.
Abbreviations:
JKUAT: Jomo Kenyatta University
KEMRI: Kenya Medical Research Institute
PHRD: Partners in Health & Research Development
UW: University of Washington
^Ortblad mentee or team member
^* With mentored Kenyan research team member as lead author