Community Health Worker And MHealth to ImProve Viral Suppression
CHAMPS
2 other identifiers
interventional
300
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
May 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2024
CompletedResults Posted
Study results publicly available
February 17, 2025
CompletedFebruary 17, 2025
January 1, 2025
3 years
September 18, 2020
January 30, 2025
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Virally Suppressed Participants
The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.
6 month follow up, 12 month follow up
Secondary Outcomes (2)
Antiretroviral Therapy (ART) Adherence - CleverCap
Up to 12 months
Change in Score on the Self-Rating Scale Item (SRSI)
6 month follow up and 12 month follow up
Study Arms (2)
Intervention
EXPERIMENTALWise App that delivers medication adherence reminders and community health worker sessions
Control
NO INTERVENTIONStandard of care
Interventions
The Intervention group will receive the Wise App that delivers medication adherence reminders.
The Intervention group will complete sessions with a community health worker (CHW).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (3)
Birmingham AIDS Outreach
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Related Publications (2)
Schnall R, Jia H, Brin M, Kay ES, Wood OR, Abua J, Batey DS. Efficacy of CHAMPS for Improving Viral Suppression: A Randomised Clinical Trial. AIDS Behav. 2025 Nov;29(11):3703-3713. doi: 10.1007/s10461-025-04811-x. Epub 2025 Jul 10.
PMID: 40634827DERIVEDWood OR, Schnall R, Kay ES, Jia H, Abua JA, Nichols TK, Olender SA, Mugavero MJ, Batey DS. A community health worker and mobile health app intervention to improve adherence to HIV medication among persons with HIV: the CHAMPS study protocol. BMC Public Health. 2023 May 24;23(1):942. doi: 10.1186/s12889-023-15616-9.
PMID: 37226141DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rebecca Schnall, PhD, MPH, RN
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Schnall, PhD, MPH, RN
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 24, 2020
Study Start
May 3, 2021
Primary Completion
April 19, 2024
Study Completion
April 19, 2024
Last Updated
February 17, 2025
Results First Posted
February 17, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share