Recruiting

CHAMPS+

Sponsor:

Columbia University

Code:

NCT06472206

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHW Sessions

CleverCap

Study Details

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.

Conditions

HIV/AIDS

Study ID

NCT06472206

Start date

Sep 23, 2024

Status verified date

Jul, 2026

Completion date

Dec 22, 2027

Anticipated

Primary completion date

Jul 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

The 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.

experimental: Intervention CHAMPS+

Participants 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

CHW Sessions

Sessions with a Community Health Worker (CHW)

CleverCap

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.

Primary outcome measure

  • Change in Viral Load [ Time Frame: Baseline, 6 month follow up, 12 month follow up. ]

Central Contacts and Locations

Central contacts

Locations

Health Services Center, Inc.

Recruiting

Hobson City, Alabama, United States, 36202

Unity Wellness Center

Recruiting

Opelika, Alabama, United States, 36801

Louisiana State University Health Sciences Center in New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

D. Scott Batey, PhD, MSW

504-862-3485dsbatey@tulane.edu

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

More Information

Sponsor

Columbia University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-07-29.