Peru Decentralized HIV Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Innovations in Decentralizing HIV Services in Peru

Conditions
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HIV

Intervention / Treatment
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* Behavioral: NIATx + ECHO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of diagnosed PWH in treatment in PHC within the district | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Care