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Pharmacy-based PrEP Delivery in Kenya

NCT ID: NCT05842122

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

5808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Hiv

Keywords

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Kenya HIV pre-exposure prophylaxis (PrEP) delivery PEP Pharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In the cluster-randomized control trial, the intervention will be introduced in a parallel fashion (i.e., all pharmacies assigned a given intervention will receive the intervention at the start of the trial).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Client-sustained delivery of pharmacy PrEP/PEP

Intervention Type BEHAVIORAL

* 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)

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).

Group Type ACTIVE_COMPARATOR

Implementor-sustained delivery of pharmacy PrEP/PEP

Intervention Type BEHAVIORAL

* 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)

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).

Group Type ACTIVE_COMPARATOR

Counselor-supported delivery of pharmacy PrEP/PEP

Intervention Type BEHAVIORAL

* 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)

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).

Group Type ACTIVE_COMPARATOR

Referral to clinic-based PrEP/PEP

Intervention Type BEHAVIORAL

* 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)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Jhpiego

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Katrina Ortblad

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Malen, MPH

Role: STUDY_CHAIR

Fred Hutch Cancer Center

Kendall Harkey, MPH

Role: STUDY_CHAIR

Fred Hutch Cancer Center

Locations

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Kenya Medical Research Institute

Kisumu, , Kenya

Site Status

Partners in Health & Research Development

Thika, , Kenya

Site Status

Countries

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Kenya

References

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Kareithi T, D Roche S, Omollo V, Ong'wen PA, Kiptinness C, Otieno P, Juma L, Malen RC, Harkey K, Anyona MO, Curran K, Banerjee P, Gichuru E, Asewe M, Yu K, Pintye J, Mugambi M, Shah PD, Sharma M, Meisner A, Were D, Ngure K, Bukusi EA, Ortblad KF. Testing different models of pharmacy-based HIV pre- and post-exposure prophylaxis initiation and management in Kenya: protocol for a cluster-randomized controlled trial. Res Sq [Preprint]. 2025 Mar 27:rs.3.rs-5968938. doi: 10.21203/rs.3.rs-5968938/v1.

Reference Type DERIVED
PMID: 40195998 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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BMGF INV-033052

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11136

Identifier Type: OTHER

Identifier Source: secondary_id

RG1123165

Identifier Type: -

Identifier Source: org_study_id