Pharmacy-based PrEP Delivery in Kenya

Launched by FRED HUTCHINSON CANCER CENTER · May 1, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Pharmacy-based PrEP Delivery in Kenya," is exploring how different ways of providing HIV prevention medications, known as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), can affect people's ability to start and continue using these services. The study will take place in 60 pharmacies across Central and Western Kenya, where pharmacies will be grouped to try out various delivery models. The goal is to see if these pharmacy-based services are as effective as the current practice, which involves referring patients to clinics for these medications.

To be eligible for this trial, participants must be at least 16 years old and interested in being screened for PrEP or PEP. They should also be at risk for HIV and meet specific safety guidelines. For pharmacies to participate, they need to be registered and have trained staff available to provide these services. Participants can expect to receive support and counseling about HIV testing and prevention, and their experiences may help improve access to these important health services in the future. It's also important to note that participants will be asked to provide a phone number for follow-up surveys related to the study.

Gender

ALL

Eligibility 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