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Alcohol Screening Program with Biomarkers for HIV-affected Youth in Zambia

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What is being tested

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

Behavioral
Who is being recruted

From 16 to 24 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorCentre for Infectious Disease Research in Zambia
Study ContactAnjali SharmaMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2025

Actual date on which the first participant was enrolled.

This study is exploring a new program to screen and help young people in Zambia who are affected by HIV and might also be consuming alcohol. It's important because alcohol use can negatively affect HIV treatment and prevention efforts. The program uses a combination of self-reported information and a urine test to check for recent alcohol use. The main goal is to see how well the program can be integrated into existing HIV services and whether it helps reduce alcohol consumption among adolescents and young adults in Lusaka, Zambia. This is crucial as it could improve overall health outcomes for these individuals. Participants will be involved in different parts of the study, starting with a screening for recent alcohol use. If alcohol use is detected, they will receive a brief intervention to discuss their drinking habits and might be referred for further treatment if needed. The study will track how many participants go through each step of this process and will also collect feedback from the participants and staff through interviews. The study will look at how well the program is working and if it helps reduce alcohol use over time. It's a pilot, so any risks or benefits are still being evaluated, but the study aims to help improve the care and support for young people dealing with both HIV and alcohol use issues.

Official TitlePiloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia
NCT06903143
Principal SponsorCentre for Infectious Disease Research in Zambia
Study ContactAnjali SharmaMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 24 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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