Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hiv
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 308
- Locations
- 5
- Primary Endpoint
- Change from Baseline Alcohol Use at 6 months
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Karen Cropsey
Primary Investigator
University of Alabama at Birmingham
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Change from Baseline Depression at 12 months(12 months)
- Change from Baseline Anxiety at 6 months(6 months)
- Change from Baseline Traumatic Stress at 12 months(12 months)
- Change from Baseline Depression at 6 months(6 months)
- Change from Baseline Substance Use at 6 months(6 months)
- Change from Baseline Substance Use at 12 months(12 months)
- Change from Baseline Anxiety at 12 months(12 months)
- Change from Baseline Traumatic Stress at 6 months(6 months)
- Change from Baseline HIV Suppression at 6 months(6 months)
- Change from Baseline HIV Suppression at 12 months(12 months)