Pharmacy-based PrEP Delivery in Kenya

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.

Conditions

• Hiv

Interventions

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)

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• Jhpiego

  collaborator OTHER

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Rachel Malen, MPH · Fred Hutch Cancer Center

• Kendall Harkey, MPH · Fred Hutch Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• Kenya

Study Locations