Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
NCT Number: NCT06472206
Acronym: CHAMPS+
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV/AIDS
Interventions: BEHAVIORAL: CHW Sessions|DEVICE: WiseApp|DEVICE: CleverCap
Sponsor: Columbia University
Collaborators: University of Alabama at Birmingham|Health Services Center, Inc.|Unity Wellness Center|Louisiana State University Health Sciences Center in New Orleans|University of Mississippi Medical Center|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-04
Completion Date: 2027-12-22
Locations: 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, 70118, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Columbia University Irving Medical Center, New York, New York, 10032, United States

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.

Primary Outcome Measures: Change in Viral Load., Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence., Baseline, 6 month follow up, 12 month follow up.
Secondary Outcome Measures: Change in ART adherence - CleverCap., The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data each day from the start to the end of trial (day 1 to 12 months), and it is a count response (number of times taking medication each day)., Up to 12 months.|Change in Score on the Self-Rating Scale Item (SRSI)., The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 5-point Likert scale to describe medication adherence over the past 4 weeks. The total score range is 1(very poor) to 6 (excellent). A higher score indicates higher self-reported adherence., 6 month follow up, 12 month follow up.