Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA
NCT ID: NCT04955795
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
308 participants
INTERVENTIONAL
2023-05-04
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telehealth for Pain and Unhealthy Drinking Among PLWH
NCT05503173
Alcohol Research Consortium in HIV-Intervention Research Arm
NCT02938377
Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons
NCT02316184
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
NCT05410561
Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia
NCT02359487
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alcohol Brief Intervention (BI)
At the time of trial enrollment, participants will receive a session of alcohol brief intervention (BI) via telephone.
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.
Common Elements Treatment Approach (CETA) via Telemedicine
Participants will be provided with 6 to 12 weekly CETA sessions via telephone.
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.
Common Elements Treatment Approach (CETA) via Telemedicine
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Common Elements Treatment Approach (CETA) via Telemedicine
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karen Cropsey
Primary Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen Cropsey, Psy.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Service Center
Anniston, Alabama, United States
UAB Family Clinic
Birmingham, Alabama, United States
Thrive
Huntsville, Alabama, United States
Five Horizons
Montgomery, Alabama, United States
Unity Wellness
Opelika, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-300007410
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.