RecruitingNot ApplicableNCT06472206

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


Sponsor

Columbia University

Enrollment

420 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining community health workers with a mobile health app can help people living with HIV in the Deep South (Alabama, Louisiana, Mississippi) achieve and maintain undetectable viral levels (viral suppression). **You may be eligible if...** - You are 18 or older and can read, write, and speak English - You have HIV with a viral load above 200 copies/mL (meaning your virus is not currently suppressed) - You own a smartphone - You live, work, or receive care in Alabama, Louisiana, or Mississippi - You are willing to give consent and allow access to your medical records **You may NOT be eligible if...** - You live in a nursing home, prison, or are receiving inpatient psychiatric care - You have a terminal illness with less than 6 months expected survival - You plan to move out of the study area within 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCHW Sessions

Sessions with a Community Health Worker (CHW).

DEVICECleverCap

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.


Locations(5)

Health Services Center, Inc.

Hobson City, Alabama, United States

Unity Wellness Center

Opelika, Alabama, United States

Louisiana State University Health Sciences Center in New Orleans

New Orleans, Louisiana, United States

Tulane University

New Orleans, Louisiana, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

View Full Details on ClinicalTrials.gov

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NCT06472206


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