Alcohol Use DisorderZCAPNCT03966885
Zambia Common Elements Treatment Approach Pilot Study
A study testing Brief Intervention and Common Elements Treatment Approach (CETA) in people with Alcohol Use Disorder and Depression, run by Columbia University at 1 site in Zambia.
Trial summary
This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Depression, Post-traumatic Stress Disorder
- What is being tested?
- Brief Intervention and Common Elements Treatment Approach (CETA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteZambia
- Study dates
- 24 Jun 2019to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Initial inclusion criteria for overall enrollment (into either the Cohort or RCT study) will be:
- HIV positive
- Receiving HIV treatment services at one of the two study clinics
- Current hazardous alcohol use, defined as an AUDIT score of ≥8 for men and ≥ 4 for women
- Provides informed consent
- Secondary inclusion for enrollment into the RCT will be:
- AUDIT scores that indicate a moderate-to-severe AUD (≥12 for women; ≥16 among men)
- AND/OR: meeting validated symptom criteria for depression (≥16 on Center for Epidemiological Studies-Depression (CES-D), trauma/anxiety (≥2.5 on HTQ), and/or substance use (≥27 for any non-tobacco/alcohol substance on ASSIST)
Who cannot join
- HIV negative
- Not receiving care at one of the study clinics
- Currently psychotic or actively suicidal
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.
Read the detailed description
Alcohol misuse is a major unaddressed barrier to ending the HIV/AIDS epidemic. Hazardous drinking increases HIV transmission, delays antiretroviral therapy (ART) uptake, reduces adherence and retention, and increases mortality. Comorbid mental health or substance misuse, similar to alcohol use alone, can also significantly undermine HIV treatment. The vast majority of people living with HIV globally live in low- and middle-income countries (LMIC). Similar to most HIV care settings in LMIC, in Zambia, the location of the current study, there are no readily available evidence-based treatments for alcohol misuse or mental health problems.
This study will enroll persons living with HIV (PLWH) who have alcohol misuse in Zambia. Participants will be recruited and screened during regular HIV care visits. Participants will be recruited by their regular care providers (i.e., peer educators, counselors, nurses, physicians) and referred to study staff if they are interested. The investigators anticipate enrolling up to 320 participants, all of whom have hazardous alcohol use. N=160 participants will be high-risk drinkers due to having either a moderate-to-severe alcohol use disorder or mental health comorbidities, or both. These participants will be randomized into the RCT. Participants who have hazardous alcohol use (but not a moderate-to-severe AUD) without mental health comorbidities (a lower risk group of participants) will not be enrolled into the RCT but will be tracked as part of a parallel cohort study. The minimum age of research subjects will be 18. Eligibility will be assessed via audio computer assisted self-interviewing (ACASI).
Participants in the 'cohort study' (i.e., lower risk participants) will receive a brief alcohol intervention. Participants in the RCT (i.e., higher risk participants) will be randomly assigned on a 1:1 basis (stratified by gender) to receive the brief intervention alone or the brief intervention plus CETA.
All participants will be evaluated for outcomes at baseline and at a six month follow-up visit. For RCT participants, the investigators will compare the effectiveness of the brief intervention alone to the brief intervention plus CETA in reducing alcohol misuse and mental health problems. For cohort participants, the investigators will collect preliminary data on whether alcohol misuse reduced at the six month follow-up but there will be no comparison/control group.
The findings from this pilot study will be used to inform future programming and research in Zambia and other LMIC to implement screening, brief intervention, and referral to treatment (SBIRT) programs for alcohol use in HIV care.
- Conditions
- Alcohol Use Disorder, Depression, Post-traumatic Stress Disorder, HIV/AIDS, Substance Use Disorders
- Being tested
- Brief Intervention, Common Elements Treatment Approach (CETA)
- Medical subject headings
- Alcoholism, Depression, Stress Disorders, Post-Traumatic, Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.
Common Elements Treatment Approach (CETA)Behavioural
The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention (BI) | Experimental | 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Receives: Behavioral: Brief Intervention |
| Brief Intervention + CETA | Experimental | 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Receives: Behavioral: Brief Intervention; Behavioral: Common Elements Treatment Approach (CETA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline.
AUDIT is a 10-item measure of hazardous alcohol use with possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.
Measured: Baseline and 6 months post-baseline
Secondary outcomes (3)
Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline.
CES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.
Measured: Baseline and 6 months post-baseline
Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline.
The HTQ is a 39-item PTSD symptom scale with possible range of 1-4 (average scale score). Higher scores are associated with greater PTSD symptom severity.
Measured: Baseline and 6 months post-baseline
Number of Participants With Any Recent Substance Use.
Any recent substance use will be defined as any use of the following substance types in the past 3 months: inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids.
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start24 Jun 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: COVID-19 precluded the study team from being able to complete all follow-up assessments.The study was halted on March 17, 2020 and did not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, University of Alabama at Birmingham, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jeremy C. Kane, Columbia University
- Investigators
- Jeremy C. Kane, PhD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966885
- Sponsor's protocol ID
- AAAS7472
- Other IDs
- R34AA027200
- Acronym
- ZCAP
- Status last verified
- Sep 2022
- First submitted
- 23 May 2019
- Last updated
- 23 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kane JC, Sharma A, Murray LK, Chander G, Kanguya T, Lasater ME, Skavenski S, Paul R, Mayeya J, Kmett Danielson C, Chipungu J, Chitambi C, Vinikoor MJ. Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial. Addict Behav Rep. 2020 Apr 29;12:100278. doi: 10.1016/j.abrep.2020.100278. eCollection 2020 Dec.
PubMed 32637558Kane JC, Sharma A, Murray LK, Chander G, Kanguya T, Skavenski S, Chitambi C, Lasater ME, Paul R, Cropsey K, Inoue S, Bosomprah S, Danielson CK, Chipungu J, Simenda F, Vinikoor MJ. Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial. AIDS Behav. 2022 Feb;26(2):523-536. doi: 10.1007/s10461-021-03408-4. Epub 2021 Jul 30.
PubMed 34328570
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zambia Common Elements Treatment Approach Pilot Study
- ClinicalTrials.gov ID
- NCT03966885
- Acronym / sponsor ID
- ZCAP / AAAS7472
- Conditions
- Alcohol Use Disorder, Depression, Post-traumatic Stress Disorder, HIV/AIDS, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 precluded the study team from being able to complete all follow-up assessments.The study was halted on March 17, 2020 and did not resume.
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, University of Alabama at Birmingham, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Posted 13 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.
Detailed description
Alcohol misuse is a major unaddressed barrier to ending the HIV/AIDS epidemic. Hazardous drinking increases HIV transmission, delays antiretroviral therapy (ART) uptake, reduces adherence and retention, and increases mortality. Comorbid mental health or substance misuse, similar to alcohol use alone, can also significantly undermine HIV treatment. The vast majority of people living with HIV globally live in low- and middle-income countries (LMIC). Similar to most HIV care settings in LMIC, in Zambia, the location of the current study, there are no readily available evidence-based treatments for alcohol misuse or mental health problems.
This study will enroll persons living with HIV (PLWH) who have alcohol misuse in Zambia. Participants will be recruited and screened during regular HIV care visits. Participants will be recruited by their regular care providers (i.e., peer educators, counselors, nurses, physicians) and referred to study staff if they are interested. The investigators anticipate enrolling up to 320 participants, all of whom have hazardous alcohol use. N=160 participants will be high-risk drinkers due to having either a moderate-to-severe alcohol use disorder or mental health comorbidities, or both. These participants will be randomized into the RCT. Participants who have hazardous alcohol use (but not a moderate-to-severe AUD) without mental health comorbidities (a lower risk group of participants) will not be enrolled into the RCT but will be tracked as part of a parallel cohort study. The minimum age of research subjects will be 18. Eligibility will be assessed via audio computer assisted self-interviewing (ACASI).
Participants in the 'cohort study' (i.e., lower risk participants) will receive a brief alcohol intervention. Participants in the RCT (i.e., higher risk participants) will be randomly assigned on a 1:1 basis (stratified by gender) to receive the brief intervention alone or the brief intervention plus CETA.
All participants will be evaluated for outcomes at baseline and at a six month follow-up visit. For RCT participants, the investigators will compare the effectiveness of the brief intervention alone to the brief intervention plus CETA in reducing alcohol misuse and mental health problems. For cohort participants, the investigators will collect preliminary data on whether alcohol misuse reduced at the six month follow-up but there will be no comparison/control group.
The findings from this pilot study will be used to inform future programming and research in Zambia and other LMIC to implement screening, brief intervention, and referral to treatment (SBIRT) programs for alcohol use in HIV care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention (BI) | Experimental | Behavioral: Brief Intervention30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. |
| Brief Intervention + CETA | Experimental | Behavioral: Brief Intervention, Behavioral: Common Elements Treatment Approach (CETA)30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Initial inclusion criteria for overall enrollment (into either the Cohort or RCT study) will be:
- AUDIT scores that indicate a moderate-to-severe AUD (≥12 for women; ≥16 among men)
- AND/OR: meeting validated symptom criteria for depression (≥16 on Center for Epidemiological Studies-Depression (CES-D), trauma/anxiety (≥2.5 on HTQ), and/or substance use (≥27 for any non-tobacco/alcohol substance on ASSIST)
Key exclusion criteria (4 listed)
- HIV negative
- Not receiving care at one of the study clinics
- Currently psychotic or actively suicidal
- Unable to provide informed consent
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 |
|---|---|---|
| Brief InterventionThe BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. | Behavioural | Brief Intervention (BI), Brief Intervention + CETA |
| Common Elements Treatment Approach (CETA)The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems. | Behavioural | Brief Intervention + CETA |
Primary outcome
Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline.
Time frame: Baseline and 6 months post-baseline
AUDIT is a 10-item measure of hazardous alcohol use with possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.
3 secondary outcomes
Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline.
Time frame: Baseline and 6 months post-baseline
Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline.
Time frame: Baseline and 6 months post-baseline
Number of Participants With Any Recent Substance Use.
Time frame: 6 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32637558Kane JC, Sharma A, Murray LK, Chander G, Kanguya T, Lasater ME, Skavenski S, Paul R, Mayeya J, Kmett Danielson C, Chipungu J, Chitambi C, Vinikoor MJ. Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial. Addict Behav Rep. 2020 Apr 29;12:100278. doi: 10.1016/j.abrep.2020.100278. eCollection 2020 Dec.
- Results publication: PubMed 34328570Kane JC, Sharma A, Murray LK, Chander G, Kanguya T, Skavenski S, Chitambi C, Lasater ME, Paul R, Cropsey K, Inoue S, Bosomprah S, Danielson CK, Chipungu J, Simenda F, Vinikoor MJ. Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial. AIDS Behav. 2022 Feb;26(2):523-536. doi: 10.1007/s10461-021-03408-4. Epub 2021 Jul 30.
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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.
Jeremy C. Kane, PhD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention and Common Elements Treatment Approach (CETA) in people with Alcohol Use Disorder and Depression, run by Columbia University at 1 site 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (time frame: Baseline and 6 months post-baseline). 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 NCT03966885, which also lists 2 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 23 Sep 2022.