NCT05842122

Pharmacy-based PrEP Delivery in Kenya

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,808 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participating study pharmacies will be 1:1:1:1 randomized to either: 1) client-sustained delivery of pharmacy PrEP/PEP services (clients pay 250 KES/visit; study team compensates pharmacies 0 KES/visit); implementor-sustained delivery of pharmacy PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 250 KES/visit); 3) Counselor-supported delivery of pharmacy PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit); or 4) referral to existing clinic-based PrEP/PEP services (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit). The primary cRCT outcomes are PrEP initiation and continuation, assessed 60 days following clients first pharmacy PrEP/PEP visit/referral. We will implement the trial for up to 16 months, or longer, depending on achievement of our primary study objectives.

Conditions

• Hiv

Interventions

Type	Name	Description
BEHAVIORAL	Client-sustained delivery of pharmacy PrEP/PEP	* Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible. * Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery * Cost to client: 250 KES per pharmacy PrEP/PEP visit * Payment to pharmacy:\* 0 KES per pharmacy PrEP/PEP visit \*Pharmacies paid by the research team (i.e., the "implementer" in this trial)
BEHAVIORAL	Implementor-sustained delivery of pharmacy PrEP/PEP	* Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible. * Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery * Cost to client: 0 KES per pharmacy PrEP/PEP visit * Payment to pharmacy:\* 250 KES per pharmacy PrEP/PEP visit \*Pharmacies paid by the research team (i.e., the "implementer" in this trial)
BEHAVIORAL	Counselor-supported delivery of pharmacy PrEP/PEP	* Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) HIV testing, and 4) PrEP (30-day supply at initiation; 90-day supply at refill visits) or PEP dispensing (28-day supply) among those determined eligible. * Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery with support from a HTS counselor (to assist with screening and HIV testing) * Cost to client: 0 KES per pharmacy PrEP/PEP visit * Payment to pharmacy:\* 100 KES per pharmacy PrEP/PEP visit \*Pharmacies paid by the research team (i.e., the "implementer" in this trial)
BEHAVIORAL	Referral to clinic-based PrEP/PEP	* Services delivered: 1) behavioral HIV risk assessment (+ counseling), 2) PrEP/PEP medical safety assessment, 3) referral to clinic-based PrEP/PEP services * Service provider(s): pharmacists or pharmaceutical technologist trained on PrEP/PEP service delivery * Cost to client: 0 KES per pharmacy PrEP/PEP referral * Payment to pharmacy:\* 100 KES per pharmacy PrEP/PEP referral \*Pharmacies paid by the research team (i.e., the "implementer" in this trial)

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-05-03
• Last updated: 2026-03-27

Locations

2 sites across 1 country: Kenya