NCT05842122Completed
Pharmacy-based PrEP Delivery in Kenya
Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
A cluster-randomized control trial (cRCT) testing different cost-sharing models for the delivery of HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) services at private pharmacies in Kenya. The goal is to assess the effect of different pharmacy-based PrEP/PEP service delivery models on PrEP/PEP initiation and continuation outcomes, compared to pharmacy referral to clinic-based PrEP/PEP services (i.e., what is currently allowed in Kenya at the moment without any changes to policies or guidelines). In the cRCT, 60 pharmacies across Central and Western Kenya will be randomized to one of 4 study arms.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5808 (actual)
- First submitted
- 5 Apr 2023
- Start date
- 20 Jun 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Fred Hutchinson Cancer Center
- Diseases
- HIV
- NCT number
- NCT05842122
What you commit to
- Study type: Interventional
- Participants enrolled: 5808
- From 20 Jun 2023 to the primary completion date, 30 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Clients
- Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
| Partners in Health & Research Development Coordinator of this site? Confirm its status | Thika | Kenya | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.