Community Health Worker And MHealth to ImProve Viral Suppression
Completed · Not applicable
Conditions studied: HIV/AIDS
In brief
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.
Key facts
- Study ID
- NCT04562649
- Run by
- Columbia University
- People needed
- 300
- Starts
- 2021-05-03
- Expected to finish
- 2024-04-19
- Last updated by the study team
- 2025-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
- Terminal illness with life expectancy <6 months
- Planning to move out of the area in the next 12 months
Where it is running
- Birmingham AIDS Outreach — Birmingham, Alabama, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Columbia University Irving Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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