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

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

Interventions

BEHAVIORAL

CHW Sessions

Sessions with a Community Health Worker (CHW).

DEVICE

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.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• Health Services Center, Inc.

  collaborator UNKNOWN

• Unity Wellness Center

  collaborator UNKNOWN

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Tulane University

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Rebecca Schnall, PhD, MPH · Columbia University

• Scott Batey, PhD, MSW · Tulane University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-23

Primary Completion

2027-07-22

Completion

2027-12-22

FDA Device

Yes

Countries

• United States

Study Locations