Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia

NCT ID: NCT06903143

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-04-30

Brief Summary

This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to:

Specific aims:

1. Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low/moderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers).

2. Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.

Conditions

Alcohol

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Screening, brief intervention, referral to treatment (SBIRT)

Sixty AYA will be recruited from three existing HIV prevention and treatment service settings in Lusaka. These are settings where our team has both previous and current successful research studies and are real-world settings where AYA are currently receiving services. The study will be introduced to AYA during morning 'health talks' held at outpatient and ART departments as well as to AYA accessing youth friendly spaces in the three sites. Interested AYA can choose to meet with an on-site research assistant (RA). The RA will obtain informed consent and administer a brief demographics questionnaire. The RA will then conduct an alcohol screening as it would be done in the SBIRT program: the administration of the AUDIT-C screener (a 3-question brief version of the full AUDIT) and will then ask the AYA to provide a urine sample in a private bathroom. The RA will then use an EtG dipcard and after ten minutes record whether the test is positive/negative for recent alcohol consumption. The A

Group Type: EXPERIMENTAL

Screening, brief intervention, and referral to treatment (SBIRT)

Intervention Type: BEHAVIORAL

The intervention will consist of a 30 minute alcohol brief intervention based on CETA' substance use reduction element; if warranted, referral will be made for the full CETA intervention, which consists of 6-12 weekly cognitive behavioral therapy-based sessions.

Interventions

Screening, brief intervention, and referral to treatment (SBIRT)

The intervention will consist of a 30 minute alcohol brief intervention based on CETA' substance use reduction element; if warranted, referral will be made for the full CETA intervention, which consists of 6-12 weekly cognitive behavioral therapy-based sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 16-24 years of age
• Residing in Lusaka, Zambia
• Meets definition of HIV-affected as evidenced as being involved in HIV testing and treatment and Adolescent Friendly Spaces Programs at the three sites (we will not ask adolescents direct questions about HIV during screening; see Recruitment section).

Exclusion Criteria

• Unable or unwilling to provide informed assent/consent

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anjali Sharma

Role: CONTACT

anjali.sharma@cidrz.org

+2600969151336

Jeremy Kane

Role: CONTACT

jk4397@cumc.columbia.edu

Other Identifiers

AAAV3113

Identifier Type: -

Identifier Source: org_study_id