NCT04562649Completed
Community Health Worker And MHealth to ImProve Viral Suppression
Source: ClinicalTrials.gov · Last updated 17 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 18 Sept 2020
- Start date
- 3 May 2021
- Primary completion date
- 19 Apr 2024
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT04562649
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 3 May 2021 to the primary completion date, 19 Apr 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
Other illness
- Terminal illness with life expectancy \<6 months
Other
- Planning to move out of the area in the next 12 months
Who the study is looking for
- Be able to communicate and read in English or Spanish
- Willing to participate in any assigned arm of the intervention
- Diagnosed with HIV ≥6 months ago
- Have an HIV-1 RNA level \>200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
- Have ART adherence \<80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
- Own a smartphone
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham AIDS Outreach Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.