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Community Health Worker And MHealth to ImProve Viral Suppression

NCT04562649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-02-17

Study results available
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Summary

The overall goal of this study is to evaluate the effects of the CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

Conditions

Interventions

DEVICE

Wise App with medication adherence reminders

The Intervention group will receive the Wise App that delivers medication adherence reminders.

BEHAVIORAL

CHW Sessions

The Intervention group will complete sessions with a community health worker (CHW).

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Rebecca Schnall, PhD, MPH, RN · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562649 on ClinicalTrials.gov