Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA

Last updated: May 1, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Use Disorder

Alcohol Dependence

Hiv

Treatment

Common Elements Treatment Approach (CETA) via Telemedicine

Alcohol Brief Intervention (BI)

Clinical Study ID

NCT04955795
IRB-300007410
P01AA029540
  • Ages 18-99
  • All Genders

Study Summary

This study is designed to examine the efficacy of a brief intervention plus a cognitive-behavioral intervention compared to brief intervention alone to address unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among people living with HIV in Alabama.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older

  • Living with HIV infection

  • Receiving HIV care at 1 of 4 participating AQMG sites (Alabama Quality ManagementGroup sites - i.e. Ryan White HIV/AIDS Program-funded community clinics in Alabama)

  • Unhealthy alcohol use documented on the AUDIT survey delivered via PRO (i.e. 4 orgreater points for women and greater than 8 points for men).

Exclusion

Exclusion Criteria:

  • Inability to use a mobile phone due to cognitive or physical impairments

  • Unable to speak sufficient English to provide informed consent and receive cognitivebehavioral therapy

  • Active suicidality or psychosis

  • Risk for acute alcohol withdrawal or seizures

Study Design

Total Participants: 308
Treatment Group(s): 2
Primary Treatment: Common Elements Treatment Approach (CETA) via Telemedicine
Phase:
Study Start date:
May 04, 2023
Estimated Completion Date:
September 30, 2027

Study Description

Participants will be randomly assigned to receive either Alcohol Brief Intervention (BI) or BI plus Common Elements Treatment Approach (T-CETA) via telephone. Participants will receive either 1 phone session of BI or 6 to 12 weekly phone sessions of BI + T-CETA. Follow ups will occur at 6 and 12 months with participants.

Participants will provide data on alcohol use, mental health comorbidities, HIV outcomes, medication adherence, and laboratory collections (CD4+ T cell count, viral load, and an alcohol biomarker: PEth) at the baseline assessment and again at the 6 and 12 month follow ups.

The study will also conduct mixed methods implementation measures with a subset of participants who are selected across various strata (i.e. gender, age, trial arm).

Connect with a study center

  • Health Service Center

    Anniston, Alabama 36201
    United States

    Active - Recruiting

  • Health Services Center

    Anniston, Alabama 36201
    United States

    Site Not Available

  • UAB Family Clinic

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Thrive

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Thrive Federally Qualified Health Services Center

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Five Horizons

    Montgomery, Alabama 36111
    United States

    Active - Recruiting

  • Medical Advocacy and Outreach

    Montgomery, Alabama 36111
    United States

    Site Not Available

  • Unity Wellness

    Opelika, Alabama 36801
    United States

    Active - Recruiting

  • Unity Wellness Clinic

    Opelika, Alabama 36801
    United States

    Site Not Available

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