Pharmacy-based delivery of HIV prevention services in Kenya
Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
This study is testing different ways to deliver HIV prevention services at pharmacies in Kenya to see which method helps people start and continue using PrEP and PEP the best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5944 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Locations | 2 sites (Kisumu and 1 other locations) |
| Trial ID | NCT05842122 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates various cost-sharing models for delivering HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) services at private pharmacies in Kenya. It involves a cluster-randomized control trial where 60 pharmacies are assigned to one of four different service delivery models, including client-sustained and counselor-supported approaches. The primary outcomes measured will be the initiation and continuation of PrEP/PEP services, assessed 60 days after the first pharmacy visit. The trial aims to determine the most effective model for improving access to these critical HIV prevention services.
Who should consider this trial
Good fit: Ideal candidates for this study include individuals seeking HIV prevention services who are willing to engage with pharmacy-based care.
Not a fit: Patients who are already receiving effective HIV prevention services through clinic-based models may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance access to HIV prevention services, leading to increased PrEP/PEP uptake and better health outcomes for at-risk populations.
How similar studies have performed: Other studies have shown promise in pharmacy-based delivery models for HIV prevention, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pharmacies * Registered with the Pharmacy and Poisons Board (PPB) * Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff * Must have a private room where HIV testing and PrEP/PEP counseling can occur * Must be willing to use a study-specific module within a digital platform (Maisha Meds) to record pharmacy PrEP/PEP dispensing * Owner must agree to allow a trained research assistant to come to the pharmacy on select days to collect data from a random subset of participants * Owner must agree to allow providers to participate in a monitored WhatsApp group, optional surveys, and optional in-depth interview * Owner must agree to allow providers to routinely engage with a technical assistant Pharmacists/HTS counselors * ≥ 18 years old * Licensed pharmacist, licensed pharmaceutical technologist, or NASCOP-certified HTS counselor * Willing to provide PrEP and PEP services, including HIV testing and associated counseling services * Completed training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing * Able and willing to provide informed consent * Complete study training * Willing to use a study-specific module within a digital platform (Maisha Meds) to document PrEP/PEP services rendered Clients * ≥ 16 years old * Interested in being screened for PrEP or PEP * Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP safety * Able and willing to provide informed consent Exclusion Criteria: Clients * Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information * Currently enrolled in any other HIV vaccine or prevention trial * Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives
Where this trial is running
Kisumu and 1 other locations
- Kenya Medical Research Institute — Kisumu, Kenya (Recruiting)
- Partners in Health & Research Development — Thika, Kenya (Recruiting)
Study contacts
- Study coordinator: Katrina F Ortblad, ScD
- Email: kortblad@fredhutch.org
- Phone: 2066677267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.