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NCT Number: NCT05910268

Peru Decentralized HIV Care

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIATx + ECHO

Behavioral

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.

Primary outcomes

  1. Percentage of diagnosed PWH in treatment in PHC within the district

    Time frame: 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 outcomes

  1. Effectiveness assessed as the extent of RIC and VS within the district

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Frederick L Altice, M.D., M.A.

CONTACT

[email protected]

203-737-2883

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Innovations in Decentralizing HIV Services in Peru

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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