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Peru Decentralized HIV Care

Innovations in Decentralizing HIV Services in Peru

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05910268
Enrollment
1450
Registered
2023-06-18
Start date
2024-04-01
Completion date
2028-07-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV Care

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.

Interventions

BEHAVIORALNIATx + 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.

Sponsors

Yale University
Lead SponsorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of diagnosed PWH in treatment in PHC within the districtup to month 54The 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

MeasureTime frameDescription
Effectiveness assessed as the extent of RIC and VS within the districtup to month 54The 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

Countries

Peru, United States

Contacts

CONTACTFrederick L Altice, M.D., M.A.
frederick.altice@yale.edu203-737-2883
PRINCIPAL_INVESTIGATORFrederick Altice, M.D., M.A.

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026