- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966885
Zambia Common Elements Treatment Approach Pilot Study (ZCAP)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lusaka, Zambia
- Centre for Infectious Disease Research in Zambia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- HIV negative
- Not receiving care at one of the study clinics
- Currently psychotic or actively suicidal
- Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Intervention (BI)
30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit.
|
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.
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Experimental: Brief Intervention + CETA
30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline and 6 months post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline and 6 months post-baseline
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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
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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.
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Baseline and 6 months post-baseline
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Number of Participants With Any Recent Substance Use.
Time Frame: 6 months post-baseline
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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.
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6 months post-baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeremy C. Kane, PhD, MPH, Columbia University
Publications and helpful links
General 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.
- Kane 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS7472
- R34AA027200 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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