Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study, which is part of the Zambia Alabama HIV Alcohol Comorbidities Program funded by NIH-NIAAA, is designed to examine the efficacy of brief and in-depth cognitive behavioral therapy-based interventions to address, unhealthy alcohol use, comorbid mental health symptoms, and HIV treatment outcomes among people living with HIV in Zambia. A 3-arm trial will be conducted with participants randomized to a brief intervention alone, the brief intervention plus referral to Common Elements Treatment Approach (CETA), or standard of care (SOC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Living with HIV

• Receiving HIV care at study site

• Hazardous alcohol use plus at least one mental health or other substance use comorbidity or moderate to severe alcohol use disorder regardless of comorbidity

• 6 months since initiation of Antiretroviral Treatment (ART)

• Suboptimal HIV care outcome based on at least 1 of the following occurences in the past year: Late (at least 14 days from scheduled) Antiretroviral Treatment (ART) drug pick up, HIV viral load (VL) above the limit of assay detection, or referral to enhanced adherence

Locations
Other Locations
Zambia
Chilenje Level 1 Hospital
RECRUITING
Lusaka
Kalingalinga Health Centre
RECRUITING
Lusaka
Kamwala Health Centre
RECRUITING
Lusaka
Contact Information
Primary
Michael Vinikoor, M.D.
michael.vinikoor@cidrz.org
265980013335
Backup
Anjali Sharma, ScD
anjali.sharma@cidrz.org
260969151336
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 680
Treatments
Experimental: Arm A- Alcohol Brief Intervention
Following enrollment and randomization, participants will receive a single session of alcohol brief intervention (BI). Further, standard of care antiretroviral therapy (ART) adherence counseling will be provided as per local guidelines.
Experimental: Arm B- Alcohol Brief Intervention plus Common Elements Treatment Approach
Following enrollment and randomization, participants will receive a single session of alcohol brief intervention (BI) and then will be referred to receive Common Elements Treatment Approach (CETA). Further, standard of care antiretroviral therapy (ART) adherence counseling will be provided as per local guidelines. For CETA, a specially trained counselor will contact the participant within 2 weeks of enrollment to arrange for CETA sessions, which occur approximately weekly. Participants will receive 6 to 12 sessions of CETA with the number of sessions based on symptoms and response to therapy.
Active_comparator: Arm C- Standard of Care
Following enrollment and randomization, participants will receive ART adherence counseling, which is the standard of care at the clinics.
Related Therapeutic Areas
Sponsors
Collaborators: Columbia University, Centre for Infectious Disease Research in Zambia
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov