Pharmacy-based PrEP Delivery in Kenya
- Conditions
- Hiv
- Interventions
- Behavioral: Pharmacy PrEP/PEP for a feeBehavioral: Pharmacy PrEP/PEP for freeBehavioral: Pharmacy referral to clinic-based PrEP/PEPBehavioral: HTS counselor supported pharmacy PrEP/PEP for free
- Registration Number
- NCT05842122
- Lead Sponsor
- Fred Hutchinson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5944
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacy PrEP/PEP for a fee Pharmacy PrEP/PEP for a fee 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). Pharmacy PrEP/PEP for free Pharmacy PrEP/PEP for free 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). Pharmacy referral to clinic-based PrEP/PEP Pharmacy 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). HTS counselor supported pharmacy PrEP/PEP for free HTS counselor supported pharmacy PrEP/PEP for free 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).
- Primary Outcome Measures
Name Time Method PrEP continuation 60 days Proportion of participants that returned to the pharmacy/clinic and refilled PrEP within 60 days of initial pharmacy-based screening, among those who initiated PrEP at the pharmacy or clinic
PrEP initiation 60 days Number of participants that initiated (i.e., were dispensed) PrEP at the pharmacy/clinic within 60 days of initial pharmacy-based screening, among those screened and found eligible for pharmacy-delivered PrEP services
- Secondary Outcome Measures
Name Time Method PrEP initiation 270 days Number of participants that initiated (i.e., were dispensed) PrEP at the pharmacy/clinic within 60 days of initial pharmacy-based screening, among those screened and found eligible for pharmacy-delivered PrEP services
PrEP continuation 270 days Proportion of participants that returned to the pharmacy/clinic and refilled PrEP within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage), among those who initiated PrEP at the pharmacy or clinic.
* Proportion of participants that refilled PrEP at least twice at a pharmacy/clinic within 270 days of initial pharmacy-based screening (regardless of any gaps in pill coverage), among those who initiated PrEP at the pharmacy or clinic
* Proportion of particpants that refilled PrEP at a pharmacy/clinic \>7 days after their expected refill date, among those who initiated PrEP at the pharmacy or clinic (i.e., stopping and restarting)PrEP adherence 60 days Proportion of participants with drug concentrations indicating adherence, among those participants randomly selected for DBS at 60 days post PrEP initiation; proportion of participants with self-reported behaviors indicative of good adherence (using the Wilson et al scale), among those who initiated PrEP at the pharmacy or clinic.
PEP initiation 60 days, 270 days Number of participants that initiated (i.e., were dispensed) PEP at the pharmacy or clinic within 3 days, among those screened and found eligible for PEP (measured at 60 days following initial pharmacy screening).
PEP-to-PrEP transition 60 days, 270 days Proportion of participants that initiated PrEP at the pharmacy or clinic within one month, among those that successfully completed PEP (tested HIV-negative between 28 and 45 days after initiating PEP) and were found eligible for PrEP (per criteria on the prescribing checklist).
PrEP/PEP initiation 60 days, 270 days Number of participants at each pharmacy that were screened and found eligible for PrEP or PEP and initiated (i.e., were dispensed) either PrEP or PEP at the pharmacy or clinic (within 3 days for PEP clients)
PrEP/PEP continuation 60 days, 270 days 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
Recurrent PEP use 60 days, 270 days Number of participants at each pharmacy that were dispensed PEP more than one time
Follow-up HIV testing 60 days Number of participants at each pharmacy engaging in HIV testing in the 60 days following the pharmacy PrEP/PEP visit (not including the initiation visit)
Behaviors associated with HIV risk 60 and 270 days Proportion of participants reporting any as well as specific self-reported behaviors associated with HIV risk according to Kenya's 8-item Risk Assessment Screening Tool, including sex with a partner of unknown HIV status or engagement in transactional sex. Also, number of reported sexual partners in the past three months, proportion of participants reporting multiple sexual partners in the past three months, and any condomless sex in the past month. All measures assessed will be assessed among those screened and found eligible for pharmacy-delivered PrEP services.
PrEP coverage (exploratory) 24 months Duration of time on PrEP based on dates of dispensing and the quantity of pills dispensed at each visit
Trial Locations
- Locations (2)
Kenya Medical Research Institute
🇰🇪Kisumu, Kenya
Partners in Health & Research Development
🇰🇪Thika, Kenya