HIV/AIDSCHARTZNCT05121064
Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia
A study testing Alcohol Brief Intervention and Common Elements Treatment Approach in people with HIV/AIDS and Alcohol-Related Disorders, run by University of Alabama at Birmingham at 5 sites in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Alcohol-Related Disorders, Mental Illness
- What is being tested?
- Alcohol Brief Intervention and Common Elements Treatment Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 5 sitesZambia
- Study dates
- 24 Jan 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Zambia5 sites
Chilenje Level 1 Hospital
Lusaka
Kalingalinga Health Centre
Lusaka
Kamwala Health Centre
Lusaka
Mtendere health centre
Lusaka
Ngombe health centre
Lusaka
About this study
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).
Read the detailed description
People with HIV are a priority population for alcohol screening and treatment; however, they may be more likely to underreport their alcohol use and may respond less well to alcohol treatments due to untreated comorbidities. Psychological treatments for unhealthy alcohol use should ideally include components to address common mental health and other substance use comorbidities. However, few current treatments can treat both substance use and mental illness with a single protocol. Further, whether integrated treatment of unhealthy alcohol use and its comorbidities is more effective than alcohol-focused treatment alone needs to be established. There are psychological alcohol treatments that are consider brief interventions (BI), which are time limited and require fewer resources to implement. There are also more complex interventions that require multiple sessions with a provider and are more time and resource intensive; however, they may have more potential for short- and long-term effectiveness.
In this study we will examine the efficacy of both a brief intervention (BI) alone and a more comprehensive and involving the BI followed by Common Elements Treatment Approach (CETA; www.cetaglobal.org) among adults with unhealthy alcohol use and HIV in urban Zambia. CETA is a transdiagnostic cognitive behavioral therapy-based intervention that can flexibly treat a range of conditions including substance use, depression, posttraumatic stress, and anxiety. Further, CETA can be delivered by professional and lay providers. There is already evidence that CETA can reduce alcohol use in the general population in Zambia. In pilot study, the BI plus CETA reduced alcohol use and mental health symptoms more at 6 months than the BI alone. Whether the BI is superior to standard of care (SOC), antiretroviral therapy adherence counseling, is not known.
This study will build on existing knowledge by looking at longer-term effects (12 months) of the interventions, assess impact on HIV outcomes (adherence to antiretrovirals, retention in HIV care, viral suppression), and to understand whether the BI is superior to current SOC. In the study, we will also evaluate implementation factors related to delivery of the two interventions within public sector HIV clinics. Understanding how to implement interventions for unhealthy alcohol use and mental illness is a major priority in the field.
We will have several groups of participants:
- 1 Adults with HIV and unhealthy alcohol use- this group will be enrolled and randomly assigned to one of three Arms (A, B or C) of the study. Arm A will receive alcohol brief intervention (BI), Arm B alcohol brief intervention (BI) plus referral to Common Elements Treatment Approach (CETA), or Arm C standard of care (SOC). The participants in Arm A will receive the single session alcohol brief intervention (BI). Participants in Arm B will also receive the BI and then be referred for CETA, which includes 6-12 sessions with a provider. The participants in Arm C will receive standard of care (SOC) only. All participants will be re-assessed at 6 and 12 months post-enrollment. Patients who participate will provide data on alcohol use, mental health and other substance use comorbidities, and HIV outcomes. Data will be generated through surveys and in some cases through laboratory tests (blood and urine). CETA will be provided by HIV peer counselors, a cadre of lay health worker that supports HIV care delivery at facilities in Zambia.
- 2 CETA counselors- this group will be enrolled and their competency to provide the intervention will be assessed through role plays. Further, they will be included in focus group discussions to understand experiences delivering CETA at HIV clinics.
- 3 Clinic staff- these individuals will be HIV care providers at the study clinics and they will be invited to focus group discussions so we can understand their perspectives on integration of interventions into their clinics.
- 4 Key informants- these are high-level policymakers and HIV and mental health/substance use policy makers and experts in Zambia who can guide us on understanding how to scale up study interventions should they be effective.
- Conditions
- HIV/AIDS, Alcohol-Related Disorders, Mental Illness
- Being tested
- Alcohol Brief Intervention, Common Elements Treatment Approach, Standard of Care
- Keywords
- HIV, Unhealthy Alcohol Use, Mental Illness, HIV care continuum, sub-Saharan Africa, Alcohol biomarkers, Implementation science
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcohol-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Brief InterventionBehavioural
Also called BI
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.
Common Elements Treatment ApproachBehavioural
Also called CETA
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.
Standard of CareBehavioural
Also called SOC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Alcohol Brief Intervention; Behavioral: 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. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (14)
Change in Alcohol Use from enrollment to 6 months
Alcohol use in the study will be measured by the Alcohol Use Disorders Identification Test (AUDIT). The minimum score on the Alcohol Use Disorders Identification Test (AUDIT) is 0 and maximum score on AUDIT is 40. For men, a score of 9 or greater indicates hazardous alcohol consumption. For women a score of 4 or greater indicates hazardous alcohol consumption. Higher AUDIT scores indicate unhealthy alcohol use.
Measured: 6 months
Change in Alcohol Use from enrollment to 12 months
Alcohol use in the study will be measured by the Alcohol Use Disorders Identification Test (AUDIT). The minimum score on the Alcohol Use Disorders Identification Test (AUDIT) is 0 and maximum score on AUDIT is 40. For men, a score of 9 or greater indicates hazardous alcohol consumption. For women a score of 4 or greater indicates hazardous alcohol consumption. Higher AUDIT scores indicate unhealthy alcohol use.
Measured: 12 months
Change in Alcohol Biomarker from enrollment to 6 months
The participant's blood level of phosphatidylethanol (PEth) will be analyzed in several ways. First describe the proportion with alcohol abstinence (PEth <8 ng/ml). Proportion with alcohol abstinence (PEth) level less than 20ng/ml indicate abstinence or light drinking. Second to describe proportion with unhealthy use (PEth>50 ng/ml). Proportion with alcohol abstinence (PEth) level of 20-200ng/ml indicate moderate level of drinking. Higher level of (PEth) indicate hazardous alcohol consumption. Ethl Glucuronide (EtG) will be analyzed to identify to identify patients with false reports of abstinence for exclusion from model.
Measured: 6 months
Change in Alcohol Biomarker from enrollment to 12 months
The participant's blood level of phosphatidylethanol (PEth) will be analyzed in several ways. First describe the proportion with alcohol abstinence (PEth <8 ng/ml). Proportion with alcohol abstinence (PEth) level less than 20ng/ml indicate abstinence or light drinking. Second to describe proportion with unhealthy use (PEth>50 ng/ml). Proportion with alcohol abstinence (PEth) level of 20-200ng/ml indicate moderate level of drinking. Higher level of (PEth) indicate hazardous alcohol consumption. Ethl Glucuronide (EtG) will be analyzed to identify to identify patients with false reports of abstinence for exclusion from model.
Measured: 12 months
Antiretroviral Treatment (ART) Medication Adherence from baseline to 6 months
Antiretroviral Treatment (ART) medication adherence will be assess based on the medication possession ratio (MPR). The medication possession ratio (MPR) metric used characterize engagement in HIV care and is a strong predictor of HIV viral suppression. These data include the date of each medication dispensation and the next scheduled drug pick-up date (based on the number of pills dispensed). MPR will be calculated from ART dispensation data that are extracted at enrollment, 6, and 12 months.
Measured: 6 months
Antiretroviral Treatment (ART) Medication Adherence from enrollment to 12 months
Antiretroviral Treatment (ART) medication adherence will be assess based on the medication possession ratio (MPR). The medication possession ratio (MPR) metric used characterize engagement in HIV care and is a strong predictor of HIV viral suppression. These data include the date of each medication dispensation and the next scheduled drug pick-up date (based on the number of pills dispensed). MPR will be calculated from ART dispensation data that are extracted at enrollment, 6, and 12 months.
Measured: 12 months
Change in HIV Viral Load from enrollment to 6 months
Defined as viral load <1,000 copies at 6 months. Testing will be done by a central lab and results will be returned to the clinic for entry into the patient's medical record so they can be used for clinical care.
Measured: 6 months
Change in HIV Viral Load from enrollment to 12 months
Defined as viral load <1,000 copies at 12 months. Testing will be done by a central lab and results will be returned to the clinic for entry into the patient's medical record so they can be used for clinical care.
Measured: 12 months
Retention in care change from enrollment to 6 months
Defined as being >28 days late for medication at 6 months calculated and compared across trial arms.
Measured: 6 months
Retention in care change from enrollment to 12 months
Defined as being >28 days late for medication at 6 months calculated and compared across trial arms.
Measured: 12 months
Changes in Mental Health and Substance Use from enrollment to 6 months
Changes in mental health, from enrollment to 6 months, based on the PHQ-9 for depression, HTQ for trauma, and GAD-7 for anxiety and changes in non-alcohol substance use based on ASSIST tool and a rapid point-of-care drug test
Measured: 6 months
Changes in Mental Health and Substance Use from enrollment to 12 months
Changes in mental health, from enrollment to 12 months, based on the PHQ-9 for depression, HTQ for trauma, and GAD-7 for anxiety and changes in non-alcohol substance use based on ASSIST tool and a rapid point-of-care drug test
Measured: 12 months
Change in Health Related Quality of Life (QoL) from enrollment to 6 months
Change in health-related Quality of Life (QoL) based on EQ-5D at enrollment and 6 months
Measured: 6 months
Change in Health Related Quality of Life (QoL) from enrollment to 12 months
Change in health-related Quality of Life (QoL) based on EQ-5D at enrollment and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start24 Jan 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- People meeting criteria will be assigned at random to one of 3 study arms.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Centre for Infectious Disease Research in Zambia, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Johns Hopkins Bloomberg School of Public Health, University of Zambia
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121064
- Sponsor's protocol ID
- IRB-300008297
- Other IDs
- P01AA029540
- Acronym
- CHARTZ
- Status last verified
- Jan 2026
- First submitted
- 12 Nov 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36791907Vinikoor 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.
PubMed 35761776Figge 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.
PubMed 35590348Kane 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.
PubMed 34026235Murray 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.
PubMed 25620867
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia
- ClinicalTrials.gov ID
- NCT05121064
- Acronym / sponsor ID
- CHARTZ / IRB-300008297
- Conditions
- HIV/AIDS, Alcohol-Related Disorders, Mental Illness
- Keywords
- HIV, Unhealthy Alcohol Use, Mental Illness, HIV care continuum, sub-Saharan Africa, Alcohol biomarkers, Implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Columbia University, Centre for Infectious Disease Research in Zambia, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Johns Hopkins Bloomberg School of Public Health, University of Zambia
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
People with HIV are a priority population for alcohol screening and treatment; however, they may be more likely to underreport their alcohol use and may respond less well to alcohol treatments due to untreated comorbidities. Psychological treatments for unhealthy alcohol use should ideally include components to address common mental health and other substance use comorbidities. However, few current treatments can treat both substance use and mental illness with a single protocol. Further, whether integrated treatment of unhealthy alcohol use and its comorbidities is more effective than alcohol-focused treatment alone needs to be established. There are psychological alcohol treatments that are consider brief interventions (BI), which are time limited and require fewer resources to implement. There are also more complex interventions that require multiple sessions with a provider and are more time and resource intensive; however, they may have more potential for short- and long-term effectiveness.
In this study we will examine the efficacy of both a brief intervention (BI) alone and a more comprehensive and involving the BI followed by Common Elements Treatment Approach (CETA; www.cetaglobal.org) among adults with unhealthy alcohol use and HIV in urban Zambia. CETA is a transdiagnostic cognitive behavioral therapy-based intervention that can flexibly treat a range of conditions including substance use, depression, posttraumatic stress, and anxiety. Further, CETA can be delivered by professional and lay providers. There is already evidence that CETA can reduce alcohol use in the general population in Zambia. In pilot study, the BI plus CETA reduced alcohol use and mental health symptoms more at 6 months than the BI alone. Whether the BI is superior to standard of care (SOC), antiretroviral therapy adherence counseling, is not known.
This study will build on existing knowledge by looking at longer-term effects (12 months) of the interventions, assess impact on HIV outcomes (adherence to antiretrovirals, retention in HIV care, viral suppression), and to understand whether the BI is superior to current SOC. In the study, we will also evaluate implementation factors related to delivery of the two interventions within public sector HIV clinics. Understanding how to implement interventions for unhealthy alcohol use and mental illness is a major priority in the field.
We will have several groups of participants:
- 1 Adults with HIV and unhealthy alcohol use- this group will be enrolled and randomly assigned to one of three Arms (A, B or C) of the study. Arm A will receive alcohol brief intervention (BI), Arm B alcohol brief intervention (BI) plus referral to Common Elements Treatment Approach (CETA), or Arm C standard of care (SOC). The participants in Arm A will receive the single session alcohol brief intervention (BI). Participants in Arm B will also receive the BI and then be referred for CETA, which includes 6-12 sessions with a provider. The participants in Arm C will receive standard of care (SOC) only. All participants will be re-assessed at 6 and 12 months post-enrollment. Patients who participate will provide data on alcohol use, mental health and other substance use comorbidities, and HIV outcomes. Data will be generated through surveys and in some cases through laboratory tests (blood and urine). CETA will be provided by HIV peer counselors, a cadre of lay health worker that supports HIV care delivery at facilities in Zambia.
- 2 CETA counselors- this group will be enrolled and their competency to provide the intervention will be assessed through role plays. Further, they will be included in focus group discussions to understand experiences delivering CETA at HIV clinics.
- 3 Clinic staff- these individuals will be HIV care providers at the study clinics and they will be invited to focus group discussions so we can understand their perspectives on integration of interventions into their clinics.
- 4 Key informants- these are high-level policymakers and HIV and mental health/substance use policy makers and experts in Zambia who can guide us on understanding how to scale up study interventions should they be effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- People meeting criteria will be assigned at random to one of 3 study arms.
| Arm | Type | Receives |
|---|---|---|
| Arm A- Alcohol Brief Intervention | Experimental | Behavioral: Alcohol Brief InterventionFollowing 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. |
| Arm B- Alcohol Brief Intervention plus Common Elements Treatment Approach | Experimental | Behavioral: Alcohol Brief Intervention, Behavioral: Common Elements Treatment ApproachFollowing 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. |
| Arm C- Standard of Care | Active comparator | Behavioral: Standard of CareFollowing enrollment and randomization, participants will receive ART adherence counseling, which is the standard of care at the clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Brief InterventionAlso: BIThe 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. | Behavioural | Arm A- Alcohol Brief Intervention, Arm B- Alcohol Brief Intervention plus Common Elements Treatment Approach |
| Common Elements Treatment ApproachAlso: CETACETA 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. | Behavioural | Arm B- Alcohol Brief Intervention plus Common Elements Treatment Approach |
| Standard of CareAlso: SOCStandard 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. | Behavioural | Arm C- Standard of Care |
Primary outcome
HIV Viral Load Suppression at 6 months
Time frame: 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.
14 secondary outcomes
Change in Alcohol Use from enrollment to 6 months
Time frame: 6 months
Change in Alcohol Use from enrollment to 12 months
Time frame: 12 months
Change in Alcohol Biomarker from enrollment to 6 months
Time frame: 6 months
Change in Alcohol Biomarker from enrollment to 12 months
Time frame: 12 months
Antiretroviral Treatment (ART) Medication Adherence from baseline to 6 months
Time frame: 6 months
Antiretroviral Treatment (ART) Medication Adherence from enrollment to 12 months
Time frame: 12 months
Change in HIV Viral Load from enrollment to 6 months
Time frame: 6 months
Change in HIV Viral Load from enrollment to 12 months
Time frame: 12 months
Retention in care change from enrollment to 6 months
Time frame: 6 months
Retention in care change from enrollment to 12 months
Time frame: 12 months
Changes in Mental Health and Substance Use from enrollment to 6 months
Time frame: 6 months
Changes in Mental Health and Substance Use from enrollment to 12 months
Time frame: 12 months
Change in Health Related Quality of Life (QoL) from enrollment to 6 months
Time frame: 6 months
Change in Health Related Quality of Life (QoL) from enrollment to 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 36791907Vinikoor 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.
- Background: PubMed 35761776Vinikoor 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.
- Background: PubMed 35590348Figge 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.
- Background: PubMed 34026235Kane 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.
- Background: PubMed 25620867Murray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Brief Intervention and Common Elements Treatment Approach in people with HIV/AIDS and Alcohol-Related Disorders, run by University of Alabama at Birmingham at 5 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Viral Load Suppression at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121064, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.