Clinical trial NCT04955795: Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA
Official title: Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Alcohol Problem
Keywords: HIV Outcomes
Unhealthy Alcohol Use
Mental Health
Medication Adherence
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-07-09
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from Baseline Alcohol Use at 6 months
timeFrame: 6 months
measure: Change from Baseline Alcohol Use at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline Substance Use at 6 months
timeFrame: 6 months
measure: Change from Baseline Substance Use at 12 months
timeFrame: 12 months
measure: Change from Baseline Depression at 6 months
timeFrame: 6 months
measure: Change from Baseline Depression at 12 months
timeFrame: 12 months
measure: Change from Baseline Anxiety at 6 months
timeFrame: 6 months
measure: Change from Baseline Anxiety at 12 months
timeFrame: 12 months
measure: Change from Baseline Traumatic Stress at 6 months
timeFrame: 6 months
measure: Change from Baseline Traumatic Stress at 12 months
timeFrame: 12 months
measure: Change from Baseline HIV Suppression at 6 months
timeFrame: 6 months
measure: Change from Baseline HIV Suppression at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Health Service Center
state: Alabama
city: Birmingham
country: United States
facility: UAB Family Clinic
state: Alabama
city: Huntsville
country: United States
facility: Thrive
state: Alabama
city: Montgomery
country: United States
facility: Five Horizons
state: Alabama
city: Opelika
country: United States
facility: Unity Wellness
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen Cropsey, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: