Pharmacy Delivery to Expand the Reach of PrEP in Kenya

Study Overview
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Brief Summary
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A pilot study to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.

Detailed Description
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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. This study will occur in two phases. During Phase One, we will pilot this care pathway in six retail pharmacies in two 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 Phase Two, we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Phase One, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.

Official Title
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Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Pilot Study

Conditions
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HIV Prevention

Intervention / Treatment
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* Other: pharmacy-based PrEP delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >=18 years Interested in initiating PrEP at a pilot pharmacy (Phase One/Aim 1a and Phase Two/Aim 1c) or interested in initiating PEP and/or STI testing at a pilot pharmacy (Phase Two/Aim 1c only) Initiated PrEP at a project-affiliated CCC (Phase One/Aim 2 only) Meets all criteria (e.g., tests HIV-negative) on checklist for initiating PrEP (Phase One/Aim 1a and Phase Two/Aim 1c), PEP (Phase Two/Aim 1c only), and/or STI testing (Phase Two/Aim 1c only) Able & willing to provide written informed consent Exclusion Criteria: Currently pregnant or breastfeeding (Phase One/Aim 1a only)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: During Phases One and Two, all individuals meeting study and PrEP eligibility criteria will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) for HIV prevention at study pharmacies. During Phase Two, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Phase Two, a subset of four study pharmacies (two per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacy-based PrEP delivery<br>Participants in this experimental arm (which includes all participants) will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at community pharmacies in Kenya. During Phase Two of the study, participants will also have the option to initiate post-exposure prophylaxis (PEP) at the 12 study pharmacies, and in a subset of four study pharmacies, participants will have the option to undergo STI testing. | Other: pharmacy-based PrEP delivery<br>* The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP initiation | Number of participants who initiate PrEP at pilot pharmacies | Over 12-month duration of Phase One and the 6-month duration of Phase Two | 
| PrEP retention | Percentage of participants who returned to the pilot pharmacies (or clinic) for PrEP refills | Over 12-month duration of Phase One and the 6-month duration of Phase Two | 
| PrEP adherence | Percentage of DBS samples with drug concentrations indicating PrEP adherence | Over 12-month duration of Phase One and the 6-month duration of Phase Two | 
| Selection of pharmacy-based PrEP | Percentage of participants who initiated PrEP at a clinic and subsequently selected pharmacy-based PrEP refills | Month 0 of Phase One | 
| PEP initiation | Number of participants who initiate PEP at pilot pharmacies | Over 6-month duration of Phase Two | 
| STI testing uptake | Number of participants who undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies | Over 6-month duration of Phase Two | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition from PEP to PrEP | Number of participants who initiate PEP at a pilot pharmacy, complete the full PEP regimen, and subsequently initiate PrEP at a pilot pharmacy | Over 6-month duration of Phase Two | 
| PrEP initiation among STI testing clients | Number of participants who come to a study pharmacy for STI testing, undergo STI testing, and initiate PrEP at the pilot pharmacy during the same study visit or a subsequent study visit | Over 6-month duration of Phase Two | 
| Selection of option to self-administer HIV Risk Assessment Screening Tool | Number of participants seeking PrEP who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it) | Over 6-month duration of Phase Two | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kenya, pre-exposure prophylaxis, pharmacy, HIV self-testing, care pathway, pilot