NCT05910268

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,450

participants targeted

Target at P75+ for not_applicable hiv

Timeline
26mo left

Started Apr 2024

Longer than P75 for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Apr 2024Jul 2028

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

4.3 years

First QC Date

June 7, 2023

Last Update Submit

May 6, 2025

Conditions

Keywords

HIV Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effectiveness assessed as the extent of RIC and VS within the district

    up to month 54

Study Arms (3)

Group 1

EXPERIMENTAL

Control (month 7-12) then NIATx+ECHO (month 13-36) then Maintenance (month 37-54)

Behavioral: NIATx + ECHO

Group 2

EXPERIMENTAL

Control (month 7-18) then NIATx+ECHO (month 19-42) then Maintenance (month 43-54)

Behavioral: NIATx + ECHO

Group 3

EXPERIMENTAL

Control (month 7-24 then NIATx+ECHO (month 25-48) then Maintenance (month 49-54)

Behavioral: NIATx + ECHO

Interventions

NIATx + ECHOBEHAVIORAL

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.

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

CITBM - Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales

Bellavista, 07006, Peru

RECRUITING

Study Officials

  • Frederick Altice, M.D., M.A.

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

April 1, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations