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.
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
- Are there results?
- None posted in the registry
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
About this study
Official title: Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach
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 Alabama.
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 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.
- First posted9 Jul 2021
- Study start4 May 2023
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
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 (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Michael Vinikoor, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955795
- Sponsor's protocol ID
- IRB-300007410
- Other IDs
- P01AA029540
- Acronym
- TALC
- Status last verified
- Oct 2026
- First submitted
- 26 May 2021
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach
- ClinicalTrials.gov ID
- NCT04955795
- Acronym / sponsor ID
- TALC / IRB-300007410
- Conditions
- Hiv, Alcohol Problem
- Keywords
- HIV Outcomes, Unhealthy Alcohol Use, Mental Health, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Alabama.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Brief Intervention (BI) | Active comparator | Behavioral: Alcohol Brief Intervention (BI)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. |
| Common Elements Treatment Approach (CETA) via Telemedicine | Experimental | Behavioral: Alcohol Brief Intervention (BI), Behavioral: Common Elements Treatment Approach (CETA) via TelemedicineParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Brief Intervention (BI)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. | Behavioural | Alcohol Brief Intervention (BI), Common Elements Treatment Approach (CETA) via Telemedicine |
| Common Elements Treatment Approach (CETA) via TelemedicineCETA 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. | Behavioural | Common Elements Treatment Approach (CETA) via Telemedicine |
Primary outcome
Change from baseline in self-reported 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. This outcome will be the change in AUDIT from enrollment to 6 months.
8 secondary outcomes
Change from baseline substance use at 6 months
Time frame: 6 months
Change from Baseline Substance Use at 12 months
Time frame: 12 months
Change from Baseline Depression at 6 months
Time frame: 6 months
Change from Baseline Depression at 12 months
Time frame: 12 months
Change from Baseline Anxiety at 6 months
Time frame: 6 months
Change from Baseline Anxiety at 12 months
Time frame: 12 months
Change from Baseline Traumatic Stress at 6 months
Time frame: 6 months
Change from Baseline Traumatic Stress at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Vinikoor, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in self-reported alcohol use at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.