Study 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.
Zambia Common Elements Treatment Approach Pilot Study
ZCAP
2 other identifiers
interventional
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
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
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2020
CompletedResults Posted
Study results publicly available
September 13, 2022
CompletedSeptember 23, 2022
September 1, 2022
9 months
May 23, 2019
July 26, 2022
September 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
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.
Baseline and 6 months post-baseline
Number of Participants With Any Recent Substance Use.
6 months post-baseline
Study Arms (2)
Brief Intervention (BI)
EXPERIMENTAL30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit.
Brief Intervention + CETA
EXPERIMENTAL30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- HIV negative
- Not receiving care at one of the study clinics
- Currently psychotic or actively suicidal
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Centre for Infectious Disease Research in Zambiacollaborator
- University of Alabama at Birminghamcollaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (1)
Centre for infectious Disease Research in Zambia
Lusaka, Zambia
Related Publications (2)
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.
PMID: 32637558BACKGROUNDKane 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.
PMID: 34328570RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was stopped early due to COVID-19. Only participants who had completed their 6-month follow-up visit by March 17th, 2020 were included in analysis.
Results Point of Contact
- Title
- Jeremy Kane, PhD, MPH
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy C. Kane, PhD, MPH
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Primary outcomes are evaluated via Audio Computer Assisted Self-Interviewing (ACASI)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Epidemiology
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 29, 2019
Study Start
June 24, 2019
Primary Completion
March 17, 2020
Study Completion
March 17, 2020
Last Updated
September 23, 2022
Results First Posted
September 13, 2022
Record last verified: 2022-09