TelePharm PrEP/PEP

Официальное название

Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Telehealth delivery of pharmacy PrEP/PEP
  Remote nurses screen, counsel, and guide HIV self-testing for pharmacy clients; pharmacy providers dispense PrEP or PEP. SMS support from remote nurses available between pharmacy visits.
• Другое Standard pharmacy PrEP/PEP delivery
  Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.

Первичные конечные точки

• PrEP/PEP initiation [Срок оценки: 18 months post implementation]
• PrEP/PEP continuation [Срок оценки: 18 months post implementation]

Вторичные конечные точки (12)

• PrEP initiation [Срок оценки: 18 months post implementation]
• PEP initiation [Срок оценки: 18 months post implementation]
• PrEP/PEP use [Срок оценки: 1.5 and 6 months from initiation]
• PrEP use [Срок оценки: 1.5 and 6 months from initiation]
• PEP use [Срок оценки: 1.5 and 6 months from initiation]
• PrEP refill [Срок оценки: 18 months post implementation]
• Repeat PEP [Срок оценки: 18 months post implementation]
• PEP-to-PrEP [Срок оценки: 18 months post implementation]
• Engaged with 1+ product [Срок оценки: 18 months post implementation]
• On-demand PrEP use [Срок оценки: 6 months from initiation]
• PEP-in-Pocket use [Срок оценки: 6 months from initiation]
• Product choice [Срок оценки: 18 months post implementation]

Критерии участия

Критерии включения

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
• >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

Clients

• ≥ 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Kenya · 1 центр

• Kenya Medical Research Institute — Kisumu

Идентификаторы

NCT: NCT07561658 · RG1125680 · R01MH140465

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗