Peru Decentralized HIV Care

Not Applicable

Recruiting

• Conditions: HIV
• Interventions: Behavioral: NIATx + ECHO

• Registration Number: NCT05910268
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-18
• Study Start: 2024-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 3	NIATx + ECHO	Control (month 7-24 then NIATx+ECHO (month 25-48) then Maintenance (month 49-54)
Group 1	NIATx + ECHO	Control (month 7-12) then NIATx+ECHO (month 13-36) then Maintenance (month 37-54)
Group 2	NIATx + ECHO	Control (month 7-18) then NIATx+ECHO (month 19-42) then Maintenance (month 43-54)

Primary Outcome Measures

Name	Time	Method
Percentage of diagnosed PWH in treatment in PHC within the district	up to month 54	The percentage of diagnosed PWH in treatment in PHC within the district will be used to assess the extent to which decentralized services are adopted and scaled-up in PHCs. Higher percentage indicates more services adopted and scaled-up.

Secondary Outcome Measures

Name	Time	Method
Effectiveness assessed as the extent of RIC and VS within the district	up to month 54	The extent to which PWH are transferred from SHCs to PHCs and consequently are RIC and achieve VS assessed by the number of participants that are RIC and achieve VS

Trial Locations

Locations (2)

CITBM - Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales; 🇵🇪 Bellavista, Peru

Yale University; 🇺🇸 New Haven, Connecticut, United States