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Recruiting NCT05910268

Peru Decentralized HIV Care

No phase Interventional HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NIATx + ECHO.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Peru
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Innovations in Decentralizing HIV Services in Peru

Overview

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

  • Behavioral 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.

Primary outcome measures

  • Percentage of diagnosed PWH in treatment in PHC within the district [Time frame: up to month 54]
Secondary outcome measures (1)
  • Effectiveness assessed as the extent of RIC and VS within the district [Time frame: up to month 54]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Yale University — New Haven
Peru · 1 center
  • CITBM - Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales — Bellavista

Identifiers

NCT: NCT05910268 · 2000035127 · 1R01AI177082-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗