N/A
N=300
Community Health Worker And MHealth to ImProve Viral Suppression
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04562649 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Virally Suppressed Participants — 97; 94; 79; 89 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wise App with medication adherence reminders (Device); CHW Sessions (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Virally Suppressed Participants |
97; 94; 79; 89 | — |
| SECONDARY Antiretroviral Therapy (ART) Adherence - CleverCap |
244 | — |
| SECONDARY Change in Score on the Self-Rating Scale Item (SRSI) |
0.04; -0.08 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04562649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.