Peru Decentralized HIV Care
Innovations in Decentralizing HIV Services in Peru
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frederick L Altice, M.D., M.A.
- Phone Number: 203-737-2883
- Email: frederick.altice@yale.edu
Study Locations
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Bellavista, Peru, 07006
- Recruiting
- CITBM - Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
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Connecticut
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New Haven, Connecticut, United States, 06520
- Not yet recruiting
- Yale University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential 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)
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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.
|
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Experimental: Group 2
Control (month 7-18) then NIATx+ECHO (month 19-42) then Maintenance (month 43-54)
|
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)
|
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 |
|---|---|---|
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Percentage of diagnosed PWH in treatment in PHC within the district
Time Frame: up to month 54
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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
Sponsor
Investigators
- Principal Investigator: Frederick Altice, M.D., M.A., Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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