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NCT Number: NCT04955795

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from Baseline Alcohol Use at 6 months

    Time frame: 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.

  2. Change from Baseline Alcohol Use at 6 months

    Time frame: 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.

Secondary outcomes

  1. Change from Baseline Substance Use at 6 months

    Time frame: 6 months

    Defined by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). The minimum score on each substance (i.e. tobacco, alcohol, cannabis, cocaine, amphetamines, inhalants, sedatives, hallucinogens, opioids, or other substances) is 0 to 3 (Low health risk). Moderate health risk is defined as a score of 4-26. High heath risk is defined as a score of 27 and higher. Higher scores indicate greater risk for health issues as a result of substance use.

  2. Change from Baseline Substance Use at 12 months

    Time frame: 12 months

    Defined by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). The minimum score on each substance (i.e. tobacco, alcohol, cannabis, cocaine, amphetamines, inhalants, sedatives, hallucinogens, opioids, or other substances) is 0 to 3 (Low health risk). Moderate health risk is defined as a score of 4-26. High heath risk is defined as a score of 27 and higher. Higher scores indicate greater risk for health issues as a result of substance use.

  3. Change from Baseline Depression at 6 months

    Time frame: 6 months

    Defined by the Patient Health Questionnaire-9 (PHQ9) validated tool. The minimum score on this measure is 0 and the maximum score on this measure is 27. Higher scores on this measure indicates a worse outcome.

  4. Change from Baseline Depression at 12 months

    Time frame: 12 months

    Defined by the Patient Health Questionnaire-9 (PHQ9) validated tool. The minimum score on this measure is 0 and the maximum score on this measure is 27. Higher scores on this measure indicate a worse outcome.

  5. Change from Baseline Anxiety at 6 months

    Time frame: 6 months

    Defined by the Generalized Anxiety Disorder-7 Item (GAD-7) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 21. Higher scores on this measure indicate a worse outcome.

  6. Change from Baseline Anxiety at 12 months

    Time frame: 12 months

    Defined by the Generalized Anxiety Disorder-7 Item (GAD-7) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 21. Higher scores on this measure indicate a worse outcome.

  7. Change from Baseline Traumatic Stress at 6 months

    Time frame: 6 months

    Defined by the Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-IV (PCL-4) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 80. Higher scores on this measure indicate a worse outcome.

  8. Change from Baseline Traumatic Stress at 12 months

    Time frame: 12 months

    Defined by the Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-IV (PCL-4) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 80. Higher scores on this measure indicate a worse outcome.

  9. Change from Baseline HIV Suppression at 6 months

    Time frame: 6 months

    Defined by Viral Load <20 copies per mL. This testing will be done by the participant's physician and reported to study staff.

  10. Change from Baseline HIV Suppression at 12 months

    Time frame: 12 months

    Defined by Viral Load <20 copies per mL. This testing will be done by the participant's physician and reported to study staff.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach

Acronym: TALC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 9, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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