NCT05121064

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

November 12, 2021

Last Update Submit

January 7, 2026

Conditions

Alcohol-Related DisordersMental IllnessHIV/AIDS

Keywords

HIVUnhealthy Alcohol UseMental IllnessHIV care continuumsub-Saharan AfricaAlcohol biomarkersImplementation science

Outcome Measures

Primary Outcomes (1)

  • HIV Viral Load Suppression at 6 months

    The study will focus on HIV viral load suppression with the definition being HIV RNA concentration below the sensitivity of the assay. In Zambia, it is possible that assays with slightly different HIV RNA sensitivity (for example 20, 40, and 60 copies per milliliter) may be used. Our definition for VLS will be having HIV RNA below the level of the least sensitive assay used during the study. We will estimate and compare risk differences with 95% CIs across the three study arms (i.e. 1=HIV VS and 0=no HIV VS). HIV viral suppression (VS) is the ultimate goal of ART and has individual and public health benefits.

    6 months

Secondary Outcomes (14)

  • Change in Alcohol Use from enrollment to 6 months

    6 months

  • Change in Alcohol Use from enrollment to 12 months

    12 months

  • Change in Alcohol Biomarker from enrollment to 6 months

    6 months

  • Change in Alcohol Biomarker from enrollment to 12 months

    12 months

  • Antiretroviral Treatment (ART) Medication Adherence from baseline to 6 months

    6 months

  • +9 more secondary outcomes

Other Outcomes (3)

  • Analysis of CETA completion

    12 months

  • Process evaluation

    12 months

  • Cost effectiveness analysis

    12 months

Study Arms (3)

Arm A- Alcohol Brief Intervention

EXPERIMENTAL

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.

Behavioral: Alcohol Brief Intervention

Arm B- Alcohol Brief Intervention plus Common Elements Treatment Approach

EXPERIMENTAL

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.

Behavioral: Alcohol Brief InterventionBehavioral: Common Elements Treatment Approach

Arm C- Standard of Care

ACTIVE COMPARATOR

Following enrollment and randomization, participants will receive ART adherence counseling, which is the standard of care at the clinics.

Behavioral: Standard of Care

Interventions

Standard of CareBEHAVIORAL

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.

Also known as: SOC
Arm C- Standard of Care
Alcohol Brief InterventionBEHAVIORAL

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.

Also known as: BI
Arm A- Alcohol Brief InterventionArm B- Alcohol Brief Intervention plus Common Elements Treatment Approach
Common Elements Treatment ApproachBEHAVIORAL

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.

Also known as: CETA
Arm B- Alcohol Brief Intervention plus Common Elements Treatment Approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Plan to relocate out of Lusaka in next 6 months
  • No access to a telephone
  • Actively suicidal or alcohol intoxication and in need of immediate care
  • Currently psychotic
  • Participating in another interventional study that would interfere with participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chilenje Level 1 Hospital

Lusaka, Zambia

Location

Kalingalinga Health Centre

Lusaka, Zambia

Location

Kamwala Health Centre

Lusaka, Zambia

Location

Related Publications (5)

  • Vinikoor MJ, Sharma A, Murray LK, Figge CJ, Bosomprah S, Chitambi C, Paul R, Kanguya T, Sivile S, Nghiem V, Cropsey K, Kane JC. Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial. Contemp Clin Trials. 2023 Apr;127:107116. doi: 10.1016/j.cct.2023.107116. Epub 2023 Feb 13.

    PMID: 36791907BACKGROUND

  • Vinikoor MJ, Sikazwe I, Sharma A, Kanguya T, Chipungu J, Murray LK, Chander G, Cropsey K, Bosomprah S, Mulenga LB, Paul R, Kane J. Intersection of alcohol use, HIV infection, and the HIV care continuum in Zambia: nationally representative survey. AIDS Care. 2023 Oct;35(10):1555-1562. doi: 10.1080/09540121.2022.2092589. Epub 2022 Jun 27.

    PMID: 35761776BACKGROUND

  • Figge CJ, Kane JC, Skavenski S, Haroz E, Mwenge M, Mulemba S, Aldridge LR, Vinikoor MJ, Sharma A, Inoue S, Paul R, Simenda F, Metz K, Bolton C, Kemp C, Bosomprah S, Sikazwe I, Murray LK. Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial. Trials. 2022 May 19;23(1):417. doi: 10.1186/s13063-022-06319-4.

    PMID: 35590348BACKGROUND

  • Kane JC, Glass N, Bolton PA, Mayeya J, Paul R, Mwenge M, Murray LK. Two-year treatment effects of the common elements treatment approach (CETA) for reducing intimate partner violence and unhealthy alcohol use in Zambia. Glob Ment Health (Camb). 2021 Feb 19;8:e4. doi: 10.1017/gmh.2021.2. eCollection 2021.

    PMID: 34026235BACKGROUND

  • Murray LK, Dorsey S, Haroz E, Lee C, Alsiary MM, Haydary A, Weiss WM, Bolton P. A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries. Cogn Behav Pract. 2014 May;21(2):111-123. doi: 10.1016/j.cbpra.2013.06.005.

    PMID: 25620867BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAlcohol-Related DisordersMental Disorders

Interventions

EthanolStandard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The data manager overseeing data collection and the biostatistician analyzing study outcomes will not be aware of participant study arm until the data are locked for analysis of the primary outcome.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: People meeting criteria will be assigned at random to one of 3 study arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 16, 2021

Study Start

January 24, 2023

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

ZA(3)