Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Cluster-randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,808
- 试验地点
- 2
- 主要终点
- PrEP initiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •≥ 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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Client-sustained delivery of pharmacy PrEP/PEP (Behavioral)
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).
干预措施: Implementor-sustained delivery of pharmacy PrEP/PEP (Behavioral)
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).
干预措施: Counselor-supported delivery of pharmacy PrEP/PEP (Behavioral)
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).
干预措施: Referral to clinic-based PrEP/PEP (Behavioral)
结局指标
主要结局
PrEP initiation
时间窗: 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
时间窗: 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.
次要结局
- PrEP initiation - 270 days(270 days)
- PrEP continuation - 270 days(270 days)
- PrEP continuation - refilled at least twice 270 days(60 days)
- PrEP continuation - any stopping/restarting 270 days(270 days)
- PrEP adherence(60 days)
- PEP initiation(60 days)
- PEP initiation - 270 days(270 days)
- PEP-to-PrEP transition(60 days)
- PEP-to-PrEP transition - 270 days(270 days)
- PrEP-to-PEP transition(60 days)
- PrEP-to-PEP transition - 270 days(270 days)
- PrEP/PEP initiation(60 days)
- PrEP/PEP initiation- 270 days(270 days)
- PrEP/PEP continuation(60 days)
- PrEP/PEP continuation- 270 days(270 days)
- Recurrent PEP use(60 days)
- Recurrent PEP use- 270 days(270 days)
研究者
Katrina Ortblad
Assistant Professor
Fred Hutchinson Cancer Center