Alcohol Problem, Hiv
Conditions
Keywords
HIV Outcomes, Unhealthy Alcohol Use, Mental Health, Medication Adherence
Brief 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 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).
Interventions
BEHAVIORALAlcohol 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.
BEHAVIORALCommon 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.
Sponsors
University of Alabama at Birmingham
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in self-reported alcohol use at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Depression at 12 months | 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. |
| Change from Baseline Anxiety at 6 months | 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. |
| Change from Baseline Anxiety at 12 months | 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. |
| Change from Baseline Traumatic Stress at 6 months | 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. |
| Change from Baseline Traumatic Stress at 12 months | 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. |
| Change from baseline substance use at 6 months | 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. |
| Change from Baseline Depression at 6 months | 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. |
| Change from Baseline Substance Use at 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Vinikoor, MD
University of Alabama at Birmingham
Outcome results
None listed