N/A
N=40
Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT05938413 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Viral Load — 15; 11; 2; 1 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
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Load |
15; 11; 2; 1 | — |
| SECONDARY Antiretroviral Therapy (ART) Adherence - CleverCap |
60.08 | — |
| SECONDARY Score on the Self-Rating Scale Item (SRSI) |
5.27; 5.25 | — |
Summary
The overall goal of this study is to evaluate the feasibility of a remotely delivered 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
- Able to speak, read, and write in English or Spanish;
- Aged ≥18 years;
- Willing to provide a valid form of identification for verification;
- Willing to participate in any assigned arm of the intervention;
- Having been diagnosed with HIV ≥6 months ago;
- Have an HIV-1 RNA level >200 copies/mL as verified by provision of medical records, or have a detectable load of >500 copies/mL, as measured by dried blood spot (DBS) sample kits, or report either not being virally suppressed in the past 12 months or being virally unsuppressed in the past 12 months;
- Own a smartphone;
- Ability and willingness to provide informed consent for study participation and consent for access to medical records; and
- Live in the United States
Exclusion Criteria
- Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
- Terminal illness with life expectancy <3 months;
- Planning to move out of the country in the next 3months.
Data sourced from ClinicalTrials.gov (NCT05938413). 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.