Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,580
- 试验地点
- 1
- 主要终点
- PrEP/PEP initiations
研究概览
简要总结
In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between pharmacy visits increases PrEP/PEP initiations and continuation compared to standard PrEP/PEP delivery by pharmacy providers. The investigators hypothesize that pharmacy PrEP/PEP services delivered with telehealth support will result in better service utilization and implementation outcomes compared to standard delivery and be cost-effective to implement.
详细描述
Participating study pharmacies will be 1:1 randomized 24 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support. The primary outcomes are PrEP/PEP initiation and continuation, assessed 180 days following clients' first pharmacy PrEP/PEP visit.
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
- 15 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
- •>3 km from other study pharmacies
- •Willing to participate in research activities, including 2-day training for pharmacy providers
- •Willing to share pharmacy records with us
- •Sells HIVST kits that are WHO certified.
- •Pharmacists/remote nurses
- •≥ 18 years old
- •Licensed pharmacist, pharmaceutical technologist, or nurse
- •Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
- •Willing to complete training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
- •Able and willing to provide informed consent
- •≥ 15 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/PEP 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
Telehealth support
Pharmacy provider-led PrEP/PEP delivery, with telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing and optional 2-way SMS with remote nurses).
干预措施: Telehealth delivery of pharmacy PrEP/PEP (Other)
Standard delivery
Pharmacy provider-led PrEP/PEP delivery, without telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing).
干预措施: Standard pharmacy PrEP/PEP delivery (Other)
结局指标
主要结局
PrEP/PEP initiations
时间窗: 18 months post implementation
\# of unique clients dispensed any form of PrEP or PEP over the implementation period
PrEP/PEP continuation
时间窗: 18 months post implementation
Pharmacy-level; count outcome: # of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP 1+ times over the implementation period
次要结局
- PrEP/PEP use(1.5 and 6 months from initiation)
- PrEP initiation(18 months post implementation)
- PEP initiation(18 months post implementation)
- PrEP use(1.5 and 6 months from initiation)
- PEP use(1.5 and 6 months from initiation)
- PrEP refill(18 months post implementation)
- Repeat PEP(18 months post implementation)
- PEP-to-PrEP(18 months post implementation)
- Engaged with 1+ product(18 months post implementation)
- On-demand PrEP use(6 months from initiation)
- PEP-in-Pocket use(6 months from initiation)
- Product choice(18 months post implementation)
- PrEP adherence(1.5 months from initiation)
研究者
Katrina Ortblad
Assistant Professor
Fred Hutchinson Cancer Center