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NCT04562649 · ClinicalTrials.gov registry record · NA

Community Health Worker And MHealth to ImProve Viral Suppression

A NA study, sponsored by Columbia University.

Completed
Registry status
NA
Development phase
300
Enrollment target

NCT04562649: Completed NA study, sponsored by Columbia University.

NCT04562649 is a NA study that has completed, run by Columbia University. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04562649, a NA study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
NA
Development phase
300 participants
Enrollment target

Study 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.

Primary Outcome

The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.

Interventions

  • BEHAVIORAL CHW Sessions
  • DEVICE Wise App with medication adherence reminders

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2021-05-03
Est. Completion 2024-04-19
Phase NA
Columbia University

958 total trials

What the finished NCT04562649 record still lists

NCT04562649 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which CHW Sessions is the first listed.

NCT04562649 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04562649 about?

NCT04562649 is a clinical study titled "Community Health Worker And MHealth to ImProve Viral Suppression". 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 he...

What is the current status of trial NCT04562649?

This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2021-05-03. Estimated completion is 2024-04-19.

What interventions are being tested in trial NCT04562649?

The interventions under investigation include: CHW Sessions (BEHAVIORAL), Wise App with medication adherence reminders (DEVICE).

Who is sponsoring clinical trial NCT04562649?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04562649's enrollment target sits among peer trials

300 330th of 2000 higher than 1,630 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04562649, the US trial registry maintained by the National Library of Medicine. NCT04562649 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.