Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia

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).

Conditions

• HIV/AIDS
• Alcohol-Related Disorders
• Mental Illness

Interventions

BEHAVIORAL

Alcohol Brief Intervention

The alcohol brief intervention (BI) was based on CETA'S substance use module and was designed for one-on-one delivery. It is comprised of 6 elements (i.e. assessment, understanding impacts, exploring possibilities of change, goal setting, identifying reasons for alcohol use and skill building) including a 2-week alcohol timeline follow back assessment completed by provider. The alcohol brief intervention (BI) will be conducted by a trained counselor.

BEHAVIORAL

Common Elements Treatment Approach

CETA is a multisession cognitive behavioral therapy (CBT)-based model. CETA consists of elements: engagement, safety assessment, psychoeducation, substance use reduction, behavioral activation, cognitive coping, relaxation, exposure and problem solving. During a weekly clinic meeting, newly enrolled participants who are assigned to get CETA will be assigned to a specific counselor. The counsellor, together with their supervisor, will design an individualized treatment plan including type and order of Common Elements Treatment Approach (CETA) for each participant. The counsellor will contact participants by phone or home visit to schedule CETA session. CETA sessions will begin with standardized clinical monitoring form to track progress of treatment and each session will last 45-90 minutes.

BEHAVIORAL

Standard of Care

Standard of Care (SOC) at HIV clinics in Zambia consist of Antiretroviral Treatment (ART) adherence counselling. All participants will receive Standard of Care (SOC), but for participants in Arm C it will be the only alcohol treatment. The ART adherence counseling includes brief unstructured discussion of substance use and mental health issues with a focus on issues that reduce adherence and retention issues. ART adherence counseling is delivered in a one-on-one format between patient and counsellor and it usually lasts 5-10 minutes.

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• Centre for Infectious Disease Research in Zambia

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-24

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• Zambia

Study Locations