Hiv
Conditions
Keywords
Kenya, HIV pre-exposure prophylaxis (PrEP) delivery, PEP, Pharmacy
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.
Interventions
BEHAVIORALClient-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)
BEHAVIORALImplementor-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)
BEHAVIORALCounselor-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)
BEHAVIORALReferral 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)
Sponsors
Fred Hutchinson Cancer Center
Kenya Medical Research Institute
Jhpiego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation | 60 days | 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. |
| PrEP continuation | 60 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation - 270 days | 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 |
| PrEP continuation - 270 days | 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) |
| PrEP continuation - refilled at least twice 270 days | 60 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). |
| PrEP continuation - any stopping/restarting 270 days | 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. |
| PrEP adherence | 60 days | 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. |
| PEP initiation | 60 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 60 days following initial pharmacy screening. |
| PEP initiation - 270 days | 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. |
| PEP-to-PrEP transition | 60 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 60 days following initial pharmacy screening. |
| PEP-to-PrEP transition - 270 days | 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. |
| PrEP-to-PEP transition | 60 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 60 days following initial pharmacy screening. |
| PrEP-to-PEP transition - 270 days | 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. |
| PrEP/PEP initiation | 60 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 60 days following initial pharmacy screening. |
| PrEP/PEP initiation- 270 days | 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. |
| PrEP/PEP continuation | 60 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 60 days of initial pharmacy screening. |
| PrEP/PEP continuation- 270 days | 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. |
| Recurrent PEP use | 60 days | 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. |
| Recurrent PEP use- 270 days | 270 days | the number of participants at each pharmacy that were dispensed PEP ≥2 times as measured at 270 days of initial pharmacy screening. |
Countries
Kenya
Contacts
STUDY_CHAIRRachel Malen, MPH
Fred Hutch Cancer Center
STUDY_CHAIRKendall Harkey, MPH
Fred Hutch Cancer Center
Outcome results
None listed