Peru Decentralized HIV Care

February 28, 2024 updated by: Yale University

Innovations in Decentralizing HIV Services in Peru

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 the RE-AIM framework to assess the extent to which decentralized services are adopted and scaled-up in PHCs over 24 months of observation using NIATx combined with Project ECHO 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 Type

Interventional

Enrollment (Estimated)

1450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Peru
      • Bellavista, Peru, 07006
        • CITBM - Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Control (month 7-12) then NIATx+ECHO (month 13-36) then Maintenance (month 37-54)
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.
Experimental: Group 2
Control (month 7-18) then NIATx+ECHO (month 19-42) then Maintenance (month 43-54)
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.
Experimental: Group 3
Control (month 7-24 then NIATx+ECHO (month 25-48) then Maintenance (month 49-54)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to month 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to month 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Frederick Altice, M.D., M.A., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2000035127
  • 1R01AI177082-01A1 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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