Peru Decentralized HIV Care

Официальное название

Innovations in Decentralizing HIV Services in Peru

Обзор

The purpose of this study is to understand the processes by which HIV care is decentralized, an evidence-informed strategy to improve retention in HIV care, in Peru. Decentralization of HIV services has not been evaluated using experimental designs and urban decentralization studies of HIV are uncommon, so this study will lend important insights for future decentralization efforts in Peru and other countries.

Подробное описание

Aim 1: Using the Delphi method, to create guidelines to identify: 1) criteria for transferring patients between hub and spoke and for initiating treatment in primary health clinics (PHCs); and 2) the most important quality health indicators (QHIs) needed to be assessed at PHCs to improve Retention in Care (RIC) and Viral Suppression (VS).

Aim 2: To identify the barriers and facilitators to decentralized HIV care from patients and clinicians in Secondary Health Centers (SHCs) and PHCs in Peru, where HIV is concentrated in key populations and treated primarily in SHCs. Findings will guide a hub and spoke decentralized care model to facilitate decentralized HIV care.

Aim 3: Using a step-wedge design with 4 hub/spokes (4 SHCs + 165 PHCs), the investigators will conduct a Type 2 hybrid implementation trial using to assess the extent to which decentralized services are adopted and scaled-up in PHCs over 24 months of observation using NIATx (Network for the Improvement of Addiction Treatment) combined with ECHO (Extension for Community Healthcare Outcomes)-like tele-education to develop and enhance a Hub and Spoke model. The implementation outcomes will include the proportionate increase of People with HIV (PWH): a) treated in PHCs; b) retained in care; and 3) achieving VS. Adoption by PHCs to accept PWH, fidelity to NIATx and ECHO, and concordance with decentralization guidelines will also be assessed.

The focus of this registration is Aim 3.

Вмешательства

• Поведенческое NIATx + ECHO
  Project ECHO will be combined with NIATx to provide clinical skills to PHC staff and delivered in a hub and spoke model to connect SHC and PHC staff in delivery of HIV care. Decentralization will occur through guideline concordance, facilitated through NIATx and ECHO.

Первичные конечные точки

• Percentage of diagnosed PWH in treatment in PHC within the district [Срок оценки: up to month 54]

Вторичные конечные точки (1)

• Effectiveness assessed as the extent of RIC and VS within the district [Срок оценки: up to month 54]

Критерии участия

Inclusion Criteria for Aim 3:

Survey of PHC and SHC Clinicians (N=330):

• Currently employed at a PHC or SHC that is participating in the study. Provide consent for participation.

Continuing Professional Development (N=825):

• Currently employed as a nurse or physician who fulfilled the ECHO training requirements

Survey of PHC Leadership (N=165):

• Currently serving as the leader of a PHC.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Yale University — New Haven

Перу · 1 центр

• CITBM - Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales — Bellavista

Идентификаторы

NCT: NCT05910268 · 2000035127 · 1R01AI177082-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗