Pharmacy-based PrEP Delivery in Kenya

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

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Client-sustained delivery of pharmacy PrEP/PEP; Behavioral: Implementor-sustained delivery of pharmacy PrEP/PEP; Behavioral: Counselor-supported delivery of pharmacy PrEP/PEP; Behavioral: Referral to clinic-based PrEP/PEP

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.

• Study Type: Interventional
• Enrollment (Actual): 5808
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute
  • Thika, Kenya
    • Partners in Health & Research Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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)
Active Comparator: 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).	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)
Active Comparator: 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).	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)
Active Comparator: 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).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation - 270 days	The number of participants at each pharmacy that initiated (i.e., were dispensed) PrEP at the pharmacy or clinic within 270 days of initial pharmacy-based screening	270 days
PrEP continuation - 270 days	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 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage)	270 days
PrEP continuation - refilled at least twice 270 days	The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and refilled PrEP at least twice within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage).	60 days
PrEP continuation - any stopping/restarting 270 days	The number of participants at each pharmacy that initiated PrEP at the pharmacy or clinic and refilled PrEP more than 7 days after their expected refill date (i.e., stopping and restarting, also referred to as "PrEP reinitiation") within 270 days of initial pharmacy-based screening.	270 days
PrEP adherence	The median adherence score (0-100) among participants at each pharmacy who initiated PrEP at the pharmacy or clinic -using the Wilson et al. scale (2020, AIDS)-as measured at 60 days following initial pharmacy screening.	60 days
PEP initiation	The number of participants at each pharmacy that initiated (i.e., were dispensed) PEP ≥1 times at the pharmacy or clinic within 3 days, as measured at 60 days following initial pharmacy screening.	60 days
PEP initiation - 270 days	The number of participants at each pharmacy that initiated (i.e., were dispensed) PEP ≥1 times at the pharmacy or clinic within 3 days, as measured at 270 days following initial pharmacy screening.	270 days
PEP-to-PrEP transition	The number of participants at each pharmacy that successfully completed PEP (tested negative or self-reported testing negative for HIV between 28 and 45 days after initiating PEP at the pharmacy) and initiated PrEP at the pharmacy or clinic as measured at 60 days following initial pharmacy screening.	60 days
PEP-to-PrEP transition - 270 days	The number of participants at each pharmacy that successfully completed PEP (tested negative or self-reported testing negative for HIV between 28 and 45 days after initiating PEP at the pharmacy) and initiated PrEP at the pharmacy or clinic as measured at 270 days following initial pharmacy screening.	270 days
PrEP-to-PEP transition	The number of participants at each pharmacy that initiated (i.e. were dispensed) PrEP and subsequently initiated PEP at the pharmacy or clinic within 3 days, as measured at 60 days following initial pharmacy screening.	60 days
PrEP-to-PEP transition - 270 days	The number of participants at each pharmacy that initiated (i.e. were dispensed) PrEP and subsequently initiated PEP at the pharmacy or clinic within 3 days, as measured at 270 days following initial pharmacy screening.	270 days
PrEP/PEP initiation	The number of participants at each pharmacy that initiated (i.e., were dispensed) either PEP or PrEP at the pharmacy or clinic (within 3 days for PEP clients) as measured at 60 days following initial pharmacy screening.	60 days
PrEP/PEP initiation- 270 days	The number of participants at each pharmacy that initiated (i.e., were dispensed) either PEP or PrEP at the pharmacy or clinic (within 3 days for PEP clients) as measured at 270 days following initial pharmacy screening.	270 days
PrEP/PEP continuation	The number of participants at each pharmacy that (1) initiated PrEP and refilled PrEP or later were dispensed PEP; or (2) initiated PEP and transitioned to PrEP or later were dispensed PEP again as measured at 60 days of initial pharmacy screening.	60 days
PrEP/PEP continuation- 270 days	The number of participants at each pharmacy that (1) initiated PrEP and refilled PrEP or later were dispensed PEP; or (2) initiated PEP and transitioned to PrEP or later were dispensed PEP again as measured at 270 days of initial pharmacy screening.	270 days
Recurrent PEP use	The number of participants at each pharmacy that were dispensed PEP ≥2 times as measured at 60 days and 270 days of initial pharmacy screening.	60 days
Recurrent PEP use- 270 days	the number of participants at each pharmacy that were dispensed PEP ≥2 times as measured at 270 days of initial pharmacy screening.	270 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client acceptability	Proportion of participants that agree to statements that measure different domains of the Theoretical Framework of Acceptability (Sekhon et al., 2017, BMC Health Serv Res), which consists of seven component constructs (e.g., affective attitude, burden, perceived effectiveness).	0, 60, 270 days
Client willingness to pay	Amount eligible pharmacy PrEP clients are willing to pay for each pharmacy PrEP or PEP visit.	0, 60, 270 days
Client quality of care perceptions	Assessed using a modified perceived service quality scale (pSQ-SF6) (Carter et al., 2022, Res Social Adm Pharm), with higher score indicating higher perceived service quality.	0, 60, 270 days
Provider/counselor feasibility	Assessed using the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017, Implement Sci).	0, 60, 270 days
Provider/counselor appropriateness	Assessed using the Intervention Appropriateness Measure (IAM) (Weiner et al., 2017, Implement Sci).	0, 60, 270 days
Provider/counselor perceived self-efficacy	Proportion of participants that agree with statements that assess providers' level of confidence delivering different core components of the pharmacy PrEP intervention (e.g., counseling, HIV testing, referral, etc.).	0, 60, 270 days
Provider/counselor adaptations	Assessed using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) (Miller et al., 2021, Implement Sci).	for the full 18 months of the cRCT
Provider/counselor willingness to change	Amount pharmacy providers are willing to charge for each pharmacy PrEP or PEP visit under different scenarios.	0, 60, 270 days
Provider/counselor acceptability	Proportion of participants that agree with statements assessing different domains of the Theoretical Framework of Acceptability (Sekhon et al., 2017, BMC Health Serv Res), which consists of seven component constructs (e.g., affective attitude, burden, perceived effectiveness).	0, 60, 270 days
Fidelity	Number and proportion of participants that received different core components of the intervention (e.g., counseling on HIV risk, medical history, HIV testing, drug dispensing), as specified in the protocol.	0, 60, 270 days
Sustainability	Comparison of study outcomes during the first half and second half of implementation	24 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Kenya Medical Research Institute; Jhpiego
• Investigators: Study Chair: Rachel Malen, MPH, Fred Hutch Cancer Center; Study Chair: Kendall Harkey, MPH, Fred Hutch Cancer Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Kenya; Pharmacy; PEP; HIV pre-exposure prophylaxis (PrEP) delivery
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: RG1123165; 11136 (Other Identifier: Fred Hutchinson Cancer Center IRB); BMGF INV-033052 (Other Grant/Funding Number: Bill & Melinda Gates Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data may be available upon request at the discretion of the study PI (Ortblad).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No