HivTALCNCT04955795

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

A study testing Alcohol Brief Intervention (BI) and Common Elements Treatment Approach (CETA) via Telemedicine in people with Hiv and Alcohol Problem, run by University of Alabama at Birmingham at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study is designed to examine the efficacy of an alcohol-focused brief intervention alone versus the brief intervention plus referral to a transdiagnostic cognitive-behavioral intervention to address unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among people living with HIV in… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hiv, Alcohol Problem
What is being tested?: Alcohol Brief Intervention (BI) and Common Elements Treatment Approach (CETA) via Telemedicine
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 308 participants
Where: 1 siteUnited States
Study dates: 4 May 2023to 31 Aug 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older
Living with HIV infection
Receiving HIV care in Alabama
Unhealthy alcohol use based on AUDIT score of 4 or greater for women and 8 or greater for men.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

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

Read the detailed description

Participants will be randomly assigned to receive either Alcohol Brief Intervention (BI) or BI plus telephone-delivered Common Elements Treatment Approach (T-CETA) via telephone. Participants will receive either 1 phone session of BI or around 6 to 12 weekly phone sessions of BI + T-CETA. Follow ups assessments of the outcomes 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. sex, age, trial arm).

Conditions: Hiv, Alcohol Problem
Being tested: Alcohol Brief Intervention (BI), Common Elements Treatment Approach (CETA) via Telemedicine
Keywords: HIV Outcomes, Unhealthy Alcohol Use, Mental Health, Medication Adherence
Medical subject headings: Acquired Immunodeficiency Syndrome, Alcohol-Related Disorders, Psychological Well-Being, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alcohol Brief Intervention (BI)Behavioural
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 TelemedicineBehavioural
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.

Study groups in NCT04955795
Study group	Role	What they receive
Alcohol Brief Intervention (BI)	Active comparator	At the time of trial enrollment, participants will receive a single session of alcohol brief intervention (BI) via telephone. This session will typically last 20-40 minutes. Receives: Behavioral: Alcohol Brief Intervention (BI)
Common Elements Treatment Approach (CETA) via Telemedicine	Experimental	Participants will be provided with around 6 to 12 weekly CETA sessions via telephone. The specific number of sessions is based on symptom severity and responsiveness to treatment. Receives: Behavioral: Alcohol Brief Intervention (BI); Behavioral: Common Elements Treatment Approach (CETA) via Telemedicine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in self-reported 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. This outcome will be the change in AUDIT from enrollment to 6 months.
Measured: 6 months

Secondary outcomes (8)

Change from baseline substance use at 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. For this outcome we look at the change from enrollment to 6 months.
Measured: 6 months
Change from Baseline Substance Use at 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.
Measured: 12 months
Change from Baseline Depression at 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.
Measured: 6 months
Change from Baseline Depression at 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.
Measured: 12 months
Change from Baseline Anxiety at 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.
Measured: 6 months
Change from Baseline Anxiety at 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.
Measured: 12 months
Change from Baseline Traumatic Stress at 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.
Measured: 6 months
Change from Baseline Traumatic Stress at 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 202331 Aug 2026

First posted9 Jul 2021
Study start4 May 2023
Primary completion31 Aug 2026 (estimated)
Study completion31 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HivStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 308 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04955795
Sponsor's protocol ID: IRB-300007410
Other IDs: P01AA029540
Acronym: TALC
Status last verified: Aug 2026
First submitted: 26 May 2021
Last updated: 31 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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