NCT05938413Completed
Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 26 Jun 2023
- Start date
- 20 Jul 2023
- Primary completion date
- 7 May 2024
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT05938413
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 20 Jul 2023 to the primary completion date, 7 May 2024
- 1 site 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 \<3 months;
Other
- Planning to move out of the country in the next 3months.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University School of Nursing 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.