Pharmacy Delivery to Expand the Reach of PrEP in Kenya

University of Washington

Status: Completed

Conditions: HIV Prevention

Treatments: Other: pharmacy-based PrEP delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04558554

R34MH120106 (U.S. NIH Grant/Contract)

STUDY00009587

P30AI027757 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.

Full description

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. Prior formative qualitative research and a stakeholder meeting led to development of 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 will conduct 3 separate, consecutive studies.

During Study 1a (13 months), we will pilot this care pathway in 2 retail pharmacies evenly split between 2 different geographies in Kenya: Kisumu and Thika. Activities will include data collection aimed at potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.

During Study 1b (12 months, happening concurrently with Study 1a), we will additionally offer pharmacy-based PrEP refills only to clients who initiated PrEP at select public health clinics, to assess how many clients opt to refill PrEP at a study pharmacy (for a fee) as opposed to at the clinic (for free).

During Study 2 (6 months, happening right after Study 1a), we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Study 1a, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.

Enrollment: 1,216 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• >=18 years
• Interested in initiating PrEP at a pilot pharmacy (Study 1a and Study 2), interested in refilling PrEP at a pilot pharmacy (Study 1b), or interested in initiating PEP and/or STI testing at a pilot pharmacy (select pharmacies in Study 2 only)
• Initiated PrEP at a project-affiliated clinic (Study 1b only)
• Meets all criteria (e.g., tests HIV-negative) on checklist for initiating and/or refilling PrEP (all phases), PEP (Study 2 only), and/or STI testing (Study 2 only)
• Able & willing to provide written informed consent

Exclusion criteria

• Currently pregnant or breastfeeding (Study 1a & 1b only)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,216 participants in 3 patient groups

Study 1a: Pharmacy-based PrEP delivery Pilot (13 months)

Experimental group

Description:

Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.

Treatment:

Other: pharmacy-based PrEP delivery

Study 1b: Pharmacy-based PrEP delivery Refill (12 months)

Experimental group

Description:

Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics.

Treatment:

Other: pharmacy-based PrEP delivery

Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months)

Experimental group

Description:

Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing.

Treatment:

Other: pharmacy-based PrEP delivery