Peru Decentralized HIV Care

Yale University

Status: Enrolling

Conditions: HIV

Treatments: Behavioral: NIATx + ECHO

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05910268

1R01AI177082-01A1 (Other Grant/Funding Number)

2000035127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

1,450 participants in 3 patient groups

Group 1

Experimental group

Description:

Control (month 7-12) then NIATx+ECHO (month 13-36) then Maintenance (month 37-54)

Treatment:

Behavioral: NIATx + ECHO

Group 2

Experimental group

Description:

Control (month 7-18) then NIATx+ECHO (month 19-42) then Maintenance (month 43-54)

Treatment:

Behavioral: NIATx + ECHO

Group 3

Experimental group

Description:

Control (month 7-24 then NIATx+ECHO (month 25-48) then Maintenance (month 49-54)

Treatment:

Behavioral: NIATx + ECHO