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

Not Applicable

Recruiting

• Conditions: Hiv; Alcohol Problem
• Interventions: Behavioral: Alcohol Brief Intervention (BI); Behavioral: Common Elements Treatment Approach (CETA) via Telemedicine

• Registration Number: NCT04955795
• Lead Sponsor: University of Alabama at Birmingham

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-09
• Study Start: 2023-05-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common Elements Treatment Approach (CETA) via Telemedicine	Alcohol Brief Intervention (BI)	Participants will be provided with 6 to 12 weekly CETA sessions via telephone.
Common Elements Treatment Approach (CETA) via Telemedicine	Common Elements Treatment Approach (CETA) via Telemedicine	Participants will be provided with 6 to 12 weekly CETA sessions via telephone.
Alcohol Brief Intervention (BI)	Alcohol Brief Intervention (BI)	At the time of trial enrollment, participants will receive a session of alcohol brief intervention (BI) via telephone.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Alcohol Use at 6 months	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 Outcome Measures

Name	Time	Method
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 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 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 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.
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.
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 HIV Suppression at 6 months	6 months	Defined by Viral Load \<20 copies per mL. This testing will be done by the participant's physician and reported to study staff.
Change from Baseline HIV Suppression at 12 months	12 months	Defined by Viral Load \<20 copies per mL. This testing will be done by the participant's physician and reported to study staff.

Trial Locations

Locations (5)

Five Horizons; 🇺🇸 Montgomery, Alabama, United States

UAB Family Clinic; 🇺🇸 Birmingham, Alabama, United States

Health Service Center; 🇺🇸 Anniston, Alabama, United States

Unity Wellness; 🇺🇸 Opelika, Alabama, United States

Thrive; 🇺🇸 Huntsville, Alabama, United States