Pharmacy-based PrEP Delivery in Kenya

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Hiv

Treatments: Behavioral: Counselor-supported delivery of pharmacy PrEP/PEP; Behavioral: Referral to clinic-based PrEP/PEP; Behavioral: Implementor-sustained delivery of pharmacy PrEP/PEP; Behavioral: Client-sustained delivery of pharmacy PrEP/PEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05842122

BMGF INV-033052 (Other Grant/Funding Number)

RG1123165

11136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,808 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,808 participants in 4 patient groups

Client-sustained delivery of pharmacy PrEP/PEP

Active Comparator group

Description:

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).

Treatment:

Behavioral: Client-sustained delivery of pharmacy PrEP/PEP

Implementor-sustained delivery of pharmacy PrEP/PEP

Active Comparator group

Description:

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).

Treatment:

Behavioral: Implementor-sustained delivery of pharmacy PrEP/PEP

Counselor-supported delivery of pharmacy PrEP/PEP

Active Comparator group

Description:

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).

Treatment:

Behavioral: Counselor-supported delivery of pharmacy PrEP/PEP

Referral to clinic-based PrEP/PEP

Active Comparator group

Description:

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).

Treatment:

Behavioral: Referral to clinic-based PrEP/PEP