Pharmacy-based PrEP Delivery in Kenya

Study Overview
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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) pharmacy PrEP/PEP services for a fee (clients pay 250 KES/visit; study team compensates pharmacies 0 KES/visit); pharmacy PrEP/PEP services for free (clients pay 0 KES/visit; study team compensates pharmacies 250 KES/visit); 3) HTS counselor-supported pharmacy PrEP/PEP services for free (clients pay 0 KES/visit; study team compensates pharmacies 100 KES/visit); or 4) pharmacy 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.

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

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: Pharmacy PrEP/PEP for a fee
* Behavioral: Pharmacy PrEP/PEP for free
* Behavioral: HTS counselor supported pharmacy PrEP/PEP for free
* Behavioral: Pharmacy referral to clinic-based PrEP/PEP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a cluster-randomized control trial followed by concurrent maintenance and modification phases. 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacy PrEP/PEP for a fee<br>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: Pharmacy PrEP/PEP for a fee<br>* 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)<br>|
| Active Comparator: Pharmacy PrEP/PEP for free<br>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: Pharmacy PrEP/PEP for free<br>* 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)<br>|
| Active Comparator: HTS counselor supported pharmacy PrEP/PEP for free<br>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: HTS counselor supported pharmacy PrEP/PEP for free<br>* 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)<br>|
| Active Comparator: Pharmacy referral to clinic-based PrEP/PEP<br>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: Pharmacy referral to clinic-based PrEP/PEP<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP initiation | 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 | 60 days | 
| PrEP continuation | 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 | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP continuation | 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 >15 days after their expected refill date, among those who initiated PrEP at the pharmacy or clinic (i.e., stopping and restarting) | 270 days | 
| PrEP adherence | 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. | 60 days | 
| PEP initiation | 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). | 60 days | 
| PEP-to-PrEP transition | 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). | 60 days | 
| Behaviors associated with HIV risk | 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. | 60 and 270 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kenya, HIV pre-exposure prophylaxis (PrEP) delivery, PEP, Pharmacy