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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Hiv; Alcohol Problem

Treatments: Behavioral: Common Elements Treatment Approach (CETA) via Telemedicine; Behavioral: Alcohol Brief Intervention (BI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04955795

P01AA029540 (U.S. NIH Grant/Contract)

IRB-300007410

Details and patient eligibility

About

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.

Full 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).

Enrollment: 308 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Living with HIV infection
• Receiving HIV care at 1 of 4 participating AQMG sites (Alabama Quality Management Group 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 or greater points for women and greater than 8 points for men).

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 cognitive behavioral therapy
• Active suicidality or psychosis
• Risk for acute alcohol withdrawal or seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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308 participants in 2 patient groups

Alcohol Brief Intervention (BI)

Active Comparator group

Description:

At the time of trial enrollment, participants will receive a session of alcohol brief intervention (BI) via telephone.

Treatment:

Behavioral: Alcohol Brief Intervention (BI)

Common Elements Treatment Approach (CETA) via Telemedicine

Experimental group

Description:

Participants will be provided with 6 to 12 weekly CETA sessions via telephone.

Treatment:

Behavioral: Alcohol Brief Intervention (BI)

Behavioral: Common Elements Treatment Approach (CETA) via Telemedicine