Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Kenya
Kenya Medical Research Institute
RECRUITING
Kisumu
Partners in Health & Research Development
RECRUITING
Thika
Contact Information
Primary
Katrina F Ortblad, ScD
kortblad@fredhutch.org
2066677267
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 5944
Treatments
Active_comparator: Client-sustained delivery of pharmacy PrEP/PEP
Pharmacy providers offer clients PrEP and PEP services for a fee of 250 Kenyan Shillings (KES) per visit (study team compensates pharmacy providers 0 KES per visit).
Active_comparator: Implementor-sustained delivery of pharmacy PrEP/PEP
Pharmacy providers offer clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 250 KES per visit).
Active_comparator: Counselor-supported delivery of pharmacy PrEP/PEP
HIV testing service (HTS) counselors support pharmacy providers in offering clients PrEP and PEP services for a fee of 0 KES per visit (study team compensates pharmacy providers 100 KES per visit).
Active_comparator: Referral to clinic-based PrEP/PEP
Pharmacy providers offer clients referral to PrEP and PEP services at nearby public clinics for a fee of 0 KES per referral (study team compensates pharmacy providers 100 KES per referral).
Related Therapeutic Areas
Sponsors
Collaborators: Kenya Medical Research Institute, Jhpiego
Leads: Fred Hutchinson Cancer Center

This content was sourced from clinicaltrials.gov