Clinical trial NCT05842122: Pharmacy-based PrEP Delivery in Kenya
Official title: Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Keywords: Kenya
HIV pre-exposure prophylaxis (PrEP) delivery
PEP
Pharmacy
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Jhpiego
First posted: 2023-05-03
Enrollment: 5944
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP initiation
timeFrame: 60 days
measure: PrEP continuation
timeFrame: 60 days
Secondary outcomes:
measure: PrEP initiation
timeFrame: 270 days
measure: PrEP continuation
timeFrame: 270 days
measure: PrEP adherence
timeFrame: 60 days
measure: PEP initiation
timeFrame: 60 days, 270 days
measure: PEP-to-PrEP transition
timeFrame: 60 days, 270 days
measure: PrEP/PEP initiation
timeFrame: 60 days, 270 days
measure: PrEP/PEP continuation
timeFrame: 60 days, 270 days
measure: Recurrent PEP use
timeFrame: 60 days, 270 days
measure: Follow-up HIV testing
timeFrame: 60 days
measure: Behaviors associated with HIV risk
timeFrame: 60 and 270 days
measure: PrEP coverage (exploratory)
timeFrame: 24 months
Other outcomes:
measure: Client acceptability
timeFrame: 0, 60, 270 days
measure: Fidelity
timeFrame: 0, 60, 270 days
measure: Client willingness to pay
timeFrame: 0, 60, 270 days
measure: Client quality of care perceptions
timeFrame: 0, 60, 270 days
measure: Provider/counselor acceptability
timeFrame: 0, 60, 270 days
measure: Provider/counselor feasibility
timeFrame: 0, 60, 270 days
measure: Provider/counselor appropriateness
timeFrame: 0, 60, 270 days
measure: Provider/counselor perceived self-efficacy
timeFrame: 0, 60, 270 days
measure: Provider/counselor adaptations
timeFrame: for the full 18 months of the cRCT
measure: Provider/counselor willingness to change
timeFrame: 0, 60, 270 days
measure: Sustainability
timeFrame: 24 months
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
city: Thika
country: Kenya
facility: Partners in Health & Research Development
Study officials:
affiliation: Fred Hutch Cancer Center
name: Rachel Malen, MPH
role: STUDY_CHAIR
affiliation: Fred Hutch Cancer Center
name: Kendall Harkey, MPH
role: STUDY_CHAIR
References: