Actively Recruiting
Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+) to Improve ART Adherence and Viral Suppression in People with HIV in the Deep South
Led by Columbia University · Updated on 2025-07-04
420
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of the Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+) intervention to improve antiretroviral therapy (ART) adherence and viral load suppression among people with HIV (PWH) in Alabama, Louisiana, and Mississippi. The study focuses on addressing gaps in HIV testing, treatment adherence, and viral suppression, particularly in the US Deep South, where access to healthcare services is challenging. The intervention builds on prior research and aims to support underserved populations through culturally relevant methods. The CHAMPS+ intervention combines mobile health technology and community health workers (CHWs) to help participants manage their ART regimens. Participants in the intervention group receive a CleverCap pill bottle that tracks medication dispensing and connects wirelessly to the WiseApp, along with 10 to 12 sessions with CHWs and a sexual health log to monitor behavior. The control group receives standard health services and referrals according to Department of Health and Human Services HIV guidelines. The study includes a randomized design and evaluates clinical effectiveness and sustainability across multiple sites. Participants will be involved for up to 12 months, with assessments at baseline, 6 months, and 12 months. Researchers will measure changes in viral load and ART adherence using the CleverCap device and self-rating scales. The study also includes monitoring of sexual behaviors to reduce HIV transmission risks. Participants must own a smartphone and will be asked to provide informed consent and access to their medical records. The study excludes individuals in nursing homes, prisons, or inpatient psychiatric care, as well as those with terminal illness or planning to move within a year.
CONDITIONS
Brief Title
Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able to speak, read, and write in English
- Be 18 years of age or older
- Willing to participate in any assigned study arm
- Have an HIV-1 RNA level greater than 200 copies/mL
- Own a smartphone
- Able and willing to provide informed consent and consent for medical record access
- Live, work, or receive care in Alabama, Louisiana, or Mississippi
You will not qualify if you...
- Reside in a nursing home, prison, or receiving inpatient psychiatric care at enrollment
- Have a terminal illness with life expectancy less than 6 months
- Planning to move out of the area within the next 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants in the intervention group receive the CleverCap pill bottle and 10 to 12 sessions with Community Health Workers to support ART adherence and risk reduction. Participants in the control group receive standard health services and referrals as needed.
10 to 12 visits with Community Health Workers and ongoing use of the CleverCap device
Duration - Up to 12 months post-baseline
Participants are followed to assess changes in viral load and ART adherence after the treatment period ends.
Visits at baseline, 6 months, and 12 months for viral load and adherence assessments
Trial Site Locations
Total: 5 locations
1
Health Services Center, Inc.
Hobson City, Alabama, United States, 36202
Actively Recruiting
2
Unity Wellness Center
Opelika, Alabama, United States, 36801
Actively Recruiting
3
Louisiana State University Health Sciences Center in New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
4
Tulane University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
5
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
Research Team
R
Rebecca Schnall, PhD, MPH
M
Maeve Brin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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