NCT03966885: ZCAP

Zambia Common Elements Treatment Approach Pilot Study

Terminated NA Results posted Last updated 23 September 2022

What this trial tests

NA trial testing Brief Intervention in Alcohol Use Disorder in 160 participants. Terminated before completion.

Timeline

24 June 2019

Primary endpoint
17 March 2020

17 March 2020

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	160
Start date	24 June 2019
Primary completion	17 March 2020
Estimated completion	17 March 2020
Sites	1 location across Zambia

Drugs / interventions tested

• Brief Intervention
• Common Elements Treatment Approach (CETA)

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Depression — all drugs for Depression →
• Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →
• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Alcohol Use Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. Primary · 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.

Group	Value	95% CI
Brief Intervention (BI)	-10.5	-12.8 – -8.3
Brief Intervention + CETA	-13.7	-15.8 – -11.6

Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline. Secondary · Baseline and 6 months 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.

Group	Value	95% CI
Brief Intervention (BI)	-4.2	-7.2 – -1.1
Brief Intervention + CETA	-8.9	-11.8 – -6.0

Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline. Secondary · Baseline and 6 months 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.

Group	Value	95% CI
Brief Intervention (BI)	-0.3	-0.5 – -0.1
Brief Intervention + CETA	-0.5	-0.7 – -0.4

Number of Participants With Any Recent Substance Use. Secondary · 6 months post-baseline

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.

Group	Value	95% CI
Brief Intervention (BI)	14
Brief Intervention + CETA	16

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brief Intervention (BI)

Serious: 1/78 (1%)

Deaths: 1/78

Brief Intervention + CETA

Serious: 0/82 (0%)

Deaths: 0/82

Serious adverse events (1 terms)

Reaction	System	Brief Intervention (BI)	Brief Intervention + CETA
Anemia	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Anemia.

Data from ClinicalTrials.gov NCT03966885 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries.
   van Ginneken N, Chin WY, Lim YC, Ussif A, et al · · 2021 · cited 89× · PMID 34352116 · DOI 10.1002/14651858.cd009149.pub3
2. 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.
   Kane JC, Sharma A, Murray LK, Chander G, et al · · 2022 · cited 29× · PMID 34328570 · DOI 10.1007/s10461-021-03408-4
3. Testing the validity of the AUDIT-C and AUDIT-3 to detect unhealthy alcohol use among high-risk populations in Zambia: A secondary analysis from two randomized trials.
   Inoue S, Chitambi C, Vinikoor MJ, Kanguya T, et al · · 2021 · cited 13× · PMID 34773884 · DOI 10.1016/j.drugalcdep.2021.109156
4. Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial.
   Kane JC, Sharma A, Murray LK, Chander G, et al · · 2020 · cited 12× · PMID 32637558 · DOI 10.1016/j.abrep.2020.100278
5. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries.
   Greene MC, Kane J, Alto M, Giusto A, et al · · 2023 · cited 7× · PMID 37158538 · DOI 10.1002/14651858.cd013350.pub2