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

NCT04955795 | Recruiting DMC

• 2 other identifiers: IRB-300007410P01AA029540
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Hiv; Alcohol Problem

Keywords

HIV Outcomes; Unhealthy Alcohol Use; Mental Health; Medication Adherence

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Alcohol Use at 6 months

  Defined by the participant's score on the Alcohol Use Disorders Identification Test (AUDIT). The minimum score on the AUDIT measure is 0, and the maximum score on the AUDIT measure is 40. For women, a score of of 4 or greater indicates hazardous or harmful alcohol consumption. For men, a score of 8 or greater indicates hazardous or harmful alcohol consumption. Higher scores on the AUDIT measure indicates more hazardous or harmful alcohol consumption.

  6 months

• Change from Baseline Alcohol Use at 6 months

  Defined by the participant's blood level of phosphatidylethanol (PEth). Participants will undergo a finger prick to collect a blood sample which will be analyzed for PEth level. PEth level of less than 20 ng/mL indicates abstinence or light drinking (from not drinking to averaging less than two drinks/day for several days a week). PEth level of 20-200 ng/mL indicates moderate level of drinking (averaging between 2 to 4 drinks/day for several days a week). Higher levels of PEth in the blood indicate more hazardous or harmful alcohol consumption.

  6 months

Secondary Outcomes (10)

• Change from Baseline Substance Use at 6 months

  6 months

• Change from Baseline Substance Use at 12 months

  12 months

• Change from Baseline Depression at 6 months

  6 months

• Change from Baseline Depression at 12 months

  12 months

• Change from Baseline Anxiety at 6 months

  6 months

Study Arms (2)

Alcohol Brief Intervention (BI)

ACTIVE COMPARATOR

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

Behavioral: Alcohol Brief Intervention (BI)

Common Elements Treatment Approach (CETA) via Telemedicine

EXPERIMENTAL

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

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

Interventions

Alcohol Brief Intervention (BI) BEHAVIORAL

The BI we will use was based on CETA's substance use module and was designed for one-on-one delivery. It is comprised of 6 elements (i.e. assessment, understanding impacts, exploring change, goal setting, identifying the reasons, and skill building) including a 2-week alcohol timeline follow back assessment, which is completed by the therapist. BI will be provided by a trained research assistant who has completed consent, enrollment, and randomized procedures with the client.

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

Common Elements Treatment Approach (CETA) via Telemedicine BEHAVIORAL

CETA consists of nine key elements (i.e. engagement and education; safety assessment and planning; psychoeducation/introduction; substance use reduction; behavioral activation; cognitive coping/restructuring; relaxation; exposure; and problem solving) that address common mental health problems such as trauma, PTSD, depression, and anxiety. Participants randomized to CETA will be assigned to a CETA provider (clinical psychology or social work graduate student or master's degree substance abuse counselor). Enrolled participants will be discussed at weekly supervision meetings. An individualized treatment plan will be designed for each participant including type and order of CETA modules. The counselor will contact the participant by phone to schedule CETA sessions and follow up any missed appointments. Counselors, who will also be given a unique ID# for documentation and analysis, will carry 3-10 active CETA cases at a time depending on their experience level.

Common Elements Treatment Approach (CETA) via Telemedicine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (5)

Health Service Center

Anniston, Alabama, 36201, United States

RECRUITING

UAB Family Clinic

Birmingham, Alabama, 35233, United States

RECRUITING

Thrive

Huntsville, Alabama, 35801, United States

RECRUITING

Five Horizons

Montgomery, Alabama, 36111, United States

RECRUITING

Unity Wellness

Opelika, Alabama, 36801, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcohol-Related Disorders; Psychological Well-Being; Medication Adherence

Interventions

Ethanol

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Karen Cropsey, Psy.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jahmil Harriette, Psy.D.

CONTACT

205-975-4204; jharriette@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 9, 2021
• Study Start: May 4, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)