Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
CHAMPS+
2 other identifiers
interventional
420
1 country
5
Brief Summary
Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 22, 2027
July 4, 2025
July 1, 2025
2.8 years
June 18, 2024
July 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Viral Load
Using blood samples obtained during standard of care visits, viral load levels will be used to asses ART adherence.
Baseline, 6 month follow up, 12 month follow up.
Secondary Outcomes (2)
Change in ART adherence - CleverCap.
Up to 12 months.
Change in Score on the Self-Rating Scale Item (SRSI).
Baseline, 6 month follow up, 12 month follow up.
Study Arms (2)
Control
NO INTERVENTIONThe control condition includes standard health services offered at each site. All participants receive referrals to mental health, drug/alcohol treatment, and/or other HIV services as necessary. Standard of care at each site follows the Dept. of Health and Human Services HIV guidelines.
Intervention CHAMPS+
EXPERIMENTALParticipants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Additionally, participants will receive 10-12 sessions with CHWs, and sexual health log to keep track of their sexual behavior.
Interventions
The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.
Eligibility Criteria
You may qualify if:
- Be able to speak, read, and write in English;
- Be above 18 years of age;
- Be willing to participate in any assigned arm of the intervention;
- Have an HIV-1 RNA level \>200 copies/mL;
- Own a smartphone;
- Be able and willing to provide informed consent for study participation and consent for access to medical records.
- Live, work and or receive care in AL, LA, or MS
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; and
- Planning to move out of the area in the next 12 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- University of Alabama at Birminghamcollaborator
- Health Services Center, Inc.collaborator
- Unity Wellness Centercollaborator
- Louisiana State University Health Sciences Center in New Orleanscollaborator
- University of Mississippi Medical Centercollaborator
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
- Tulane Universitycollaborator
Study Sites (5)
Health Services Center, Inc.
Hobson City, Alabama, 36202, United States
Unity Wellness Center
Opelika, Alabama, 36801, United States
Louisiana State University Health Sciences Center in New Orleans
New Orleans, Louisiana, 70112, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Schnall, PhD, MPH
Columbia University
- PRINCIPAL INVESTIGATOR
Scott Batey, PhD, MSW
Tulane University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Disease Prevention and Health Promotion and Professor of Population and Family Health; Associate Dean of Faculty Development
Study Record Dates
First Submitted
June 18, 2024
First Posted
June 25, 2024
Study Start
September 23, 2024
Primary Completion (Estimated)
July 22, 2027
Study Completion (Estimated)
December 22, 2027
Last Updated
July 4, 2025
Record last verified: 2025-07