Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Health Services Center, Inc.
RECRUITING
Hobson City
Unity Wellness Center
RECRUITING
Opelika
Louisiana
Louisiana State University Health Sciences Center in New Orleans
RECRUITING
New Orleans
Tulane University
RECRUITING
New Orleans
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
Contact Information
Primary
Rebecca Schnall, PhD, MPH
rb897@columbia.edu
212-342-6886
Backup
Maeve Brin
mb4953@cumc.columbia.edu
212-305-8198
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2027-12-22
Participants
Target number of participants: 420
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Health Services Center, Inc., University of Mississippi Medical Center, National Institute on Minority Health and Health Disparities (NIMHD), Tulane University, Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham, Unity Wellness Center
Leads: Columbia University

This content was sourced from clinicaltrials.gov