Protocol No: ECCT/20/09/01 Date of Protocol: 23-07-2020

Study Title:

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

 

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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. 
  3. To understand the potential impact of the COVID-19 pandemic on the uptake and continuation of pharmacy-based PrEP delivery.

 

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4 1. To test pathways for pharmacy-based PrEP delivery – both initiation and refill – through pilot studies (Aims 1a and 2a). 2. To identify weak points for pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs (Aims 1b and 2b). 3. To understand the potential impact of the COVID-19 pandemic on the uptake and continuation of pharmacy-based PrEP delivery (Aim 1b only). 4. To test a refined pathway for pharmacy-based PrEP initiation and refills through an extended pilot study (Aim 1c)
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Laymans Summary:

Pre-exposure prophylaxis (PrEP) is a powerful HIV prevention tool; PrEP delivery in low resource settings will require approaches that are time- and cost-efficient, for patients, care providers, and the health care system. In this highly innovative study, we propose a new delivery model for PrEP delivery that has never been explored in an African setting: pharmacy-based PrEP delivery (with remote physician oversight). Through formative research, we have developed a care pathway for pharmacy-based PrEP delivery than we plan on pilot testing in four Kenyan pharmacies. We hypothesize that pharmacy-based PrEP delivery will be acceptable and feasible in Kenya and that individuals who uptake PrEP in pharmacies will be retained in care.

 

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Abstract of Study:

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 four retail pharmacies in Thika, Kenya. Additionally, we plan to probe for potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.

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