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NCT04955795 | RECRUITING | Hiv

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

University of Alabama at Birmingham

Information provided by (Responsible Party):

Karen Cropsey

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.

Condition or disease

Hiv

Alcohol Problem

Intervention/treatment

Alcohol Brief Intervention (BI)

Common Elements Treatment Approach (CETA) via Telemedicine

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 308 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach
Actual Study Start Date : 2023-05-04
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2027-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA

Location Details

NCT04955795

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Health Service Center

Anniston, alabama, United States, 36201

RECRUITING

United States, alabama

UAB Family Clinic

Birmingham, alabama, United States, 35233

RECRUITING

United States, alabama

Thrive

Huntsville, alabama, United States, 35801

RECRUITING

United States, alabama

Five Horizons

Montgomery, alabama, United States, 36111

RECRUITING

United States, alabama

Unity Wellness

Opelika, alabama, United States, 36801