Clinical trial NCT04558554: Pharmacy Delivery to Expand the Reach of PrEP in Kenya
Official title: Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: pre-exposure prophylaxis
Kenya
pharmacy
HIV self-testing
care pathway
pilot
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Bill and Melinda Gates Foundation
First posted: 2020-09-22
Enrollment: 1216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: During Studies 1a, 1b, and 2, all individuals meeting study and PrEP eligibility criteria will have the option Study 2, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Study 2, a subset of four study pharmacies (2 per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: PrEP Initiation
timeFrame: Over 13-month duration of Study 1a and 6-month duration of Study 2
measure: PrEP Retention
timeFrame: Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2
Secondary outcomes:
measure: PEP Initiation
timeFrame: Over 6-month duration of Study 2
measure: Selection of Pharmacy-based PrEP Refills
timeFrame: During the 12-month duration of Study 1b
measure: PrEP Adherence
timeFrame: Over 12-month duration of Study 1a and the 6-month duration of Study 2
measure: STI Testing Uptake
timeFrame: Over 6-month duration of Study 2
measure: Transition From PEP to PrEP
timeFrame: Over 6-month duration of Study 2
measure: PrEP Initiation Among STI Testing Clients
timeFrame: Over 6-month duration of Study 2
measure: Selection of Option to Self-administer HIV Risk Assessment Screening Tool
timeFrame: Over 6-month duration of Study 2
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
city: Thika
country: Kenya
facility: Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project)
Study officials:
affiliation: University of Washington
name: Katrina Ortblad, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References: