Protocol No: ECCT/20/09/04 Date of Protocol: 18-02-2020

Study Title:

Pharmacy delivery to expand the reach of PrEP in Kenya: Pilot Study

Study Objectives:

Study Objectives:

1. To test pathways for pharmacy-based PrEP delivery – both initiation and refill – through pilot studies.

2. To identify weak points for pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.

Laymans Summary:

Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP – including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills – are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. From prior formative qualitative research and a stakeholder meeting, we have developed a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We plan to pilot this care pathway in two retail pharmacies in Kisumu. Additionally, we plan to probe for potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.

Abstract of Study:

Maximizing access, minimizing costs of delivery, and reaching at-risk populations are key priorities for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV prevention. In Africa, PrEP is being added to an already-burdened public health infrastructure and the ability of the health systems to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility evaluations of PrEP in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, the costs of staffing, and healthcare providers’ unfamiliarity with delivering prevention interventions. In Kenya, retail pharmacies fill an important gap in the health care system, providing access to treatment of urgent conditions (e.g., evaluation and medication for STIs, upon presentation of a valid prescription), monitoring of chronic conditions (e.g., blood pressure testing), and preventative care (e.g., contraception). HIV testing is also now legally allowed at pharmacies through purchase of HIV self-tests or pharmacy provider-assisted HIV self-testing. Pharmacy-delivered care has many attributes that may be desirable for potential PrEP users, including convenience (as pharmacies outnumber clinics and have shorter waiting times), anonymity (compared to seeking PrEP at an HIV care center), and engagement (which may be greater for a preventative service at a pharmacy than at a clinic that prioritizes treating ill individuals). Pharmacies can offer free, subsidized, or fully fee-for-service care, and paying for a service could result in greater sustained consumer engagement. The core components of PrEP – including HIV testing, adherence and risk reduction counseling, assessment of side effects, and provision of refills – are within the scope of practice for pharmacists (including pharmaceutical technologists, common in sub-Saharan Africa), and one US model has demonstrated that PrEP can be provided by pharmacists, facilitated by oversight by a remote clinician.