The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial

Официальное название

Optimizing Low Threshold TelePrEP Care for People Who Inject Drugs in Appalachia

Обзор

The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. This study will integrate telehealth PrEP care within local health departments to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.

Вмешательства

• Поведенческое CDC PrEP with active referral
  The single session SOC utilizes structured risk assessments and educational materials recommended by the CDC, based on the CDC PrEP 101 information, and delivered one-on-one by trained study staff in about 15 minutes. This will be followed by active referral to a local provider; local providers have been identified to receive study referrals in each community. This session will occur the same day or within one week of study enrollment.
• Поведенческое TelePrEP
  The TelePrEP intervention includes an initial one-on-one in person intervention session with trained study staff that: 1) engages in provides basic education on PrEP care tailored for PWID; 2) encourages participation in a telehealth clinical evaluation for PrEP; and, 3) offers the opportunity to participate in point of care baseline testing for PrEP. At the conclusion of session 1, for those who express readiness to link with PrEP care, study staff will immediately facilitate access to the tele

Первичные конечные точки

• PrEP Initiation [Срок оценки: 3 months post-baseline]
• PrEP Initiation [Срок оценки: 6 months post-baseline]

Вторичные конечные точки (4)

• PrEP Persistence [Срок оценки: 3 months post-baseline]
• PrEP Persistence [Срок оценки: 6 months post-baseline]
• PrEP adherence [Срок оценки: 3 months post-baseline]
• PrEP adherence [Срок оценки: 6 months post-baseline]

Критерии участия

Критерии включения

• be at least 18 years of age
• report at least one occasion of injection drug use in the past month
• report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care
• be a documented client of the county health department-based SSP at the time of study entry
• express willingness to participate in a multi-session intervention and follow-up

Критерии исключения

• HIV-positive status
• current PrEP care.

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

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT06845774 · 90392 · R34DA060087-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗