NCT05842122

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,808

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

April 5, 2023

Last Update Submit

March 24, 2026

Conditions

Hiv

Keywords

KenyaHIV pre-exposure prophylaxis (PrEP) deliveryPEPPharmacy

Outcome Measures

Primary Outcomes (2)

  • PrEP initiation

    The number of participants at each pharmacy that initiated (i.e., were dispensed) PrEP at the pharmacy or clinic within 60 days of initial pharmacy-based screening. Comparisons between intervention arms and the control will rely on self-report from the 60-day client survey, while comparisons between intervention arms will employ pharmacy records.

    60 days

  • PrEP continuation

    The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and returned to the pharmacy or clinic and refilled PrEP within 60 days of initial pharmacy-based screening. Comparisons between intervention arms and the control will rely on self-report from the 60-day client survey, while comparisons between intervention arms will employ pharmacy records.

    60 days

Secondary Outcomes (17)

  • PrEP initiation - 270 days

    270 days

  • PrEP continuation - 270 days

    270 days

  • PrEP continuation - refilled at least twice 270 days

    60 days

  • PrEP continuation - any stopping/restarting 270 days

    270 days

  • PrEP adherence

    60 days

  • +12 more secondary outcomes

Study Arms (4)

Client-sustained delivery of pharmacy PrEP/PEP

ACTIVE COMPARATOR

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).

Behavioral: Client-sustained delivery of pharmacy PrEP/PEP

Implementor-sustained delivery of pharmacy PrEP/PEP

ACTIVE COMPARATOR

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).

Behavioral: Implementor-sustained delivery of pharmacy PrEP/PEP

Counselor-supported delivery of pharmacy PrEP/PEP

ACTIVE COMPARATOR

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).

Behavioral: Counselor-supported delivery of pharmacy PrEP/PEP

Referral to clinic-based PrEP/PEP

ACTIVE COMPARATOR

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).

Behavioral: Referral to clinic-based PrEP/PEP

Interventions

Counselor-supported delivery of pharmacy PrEP/PEPBEHAVIORAL

* 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)

Counselor-supported delivery of pharmacy PrEP/PEP
Referral to clinic-based PrEP/PEPBEHAVIORAL

* 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)

Referral to clinic-based PrEP/PEP
Client-sustained delivery of pharmacy PrEP/PEPBEHAVIORAL

* 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)

Client-sustained delivery of pharmacy PrEP/PEP
Implementor-sustained delivery of pharmacy PrEP/PEPBEHAVIORAL

* 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)

Implementor-sustained delivery of pharmacy PrEP/PEP

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Partners in Health & Research Development

Thika, Kenya

Location

Related Publications (2)

  • Kareithi T, Roche SD, Meisner A, Omollo V, Ong'wen PA, Harkey K, Kiptinness C, Otieno P, Juma L, Malen RC, Anyona MO, Curran K, Banerjee P, Gichuru E, Asewe M, Yu K, Pintye J, Mugambi ML, Shah PD, Sharma M, Were D, Ngure K, Bukusi EA, Ortblad KF; Pharm PrEP cRCT team. Testing different models of pharmacy-based HIV pre- and post-exposure prophylaxis initiation and management in Kenya: protocol for a cluster-randomized controlled trial. Trials. 2025 Dec 30;27(1):95. doi: 10.1186/s13063-025-09384-7.

    PMID: 41466427DERIVED

  • 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.

    PMID: 40195998DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Rachel Malen, MPH

    Fred Hutch Cancer Center

    STUDY CHAIR

  • Kendall Harkey, MPH

    Fred Hutch Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 3, 2023

Study Start

June 20, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

March 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Deidentified data may be available upon request at the discretion of the study PI (Ortblad).

Locations

KE(2)