Zambia Common Elements Treatment Approach Pilot Study

Not Applicable

Terminated

• Conditions: Alcohol Use Disorder; HIV/AIDS; Substance Use Disorders; Depression; Post-traumatic Stress Disorder
• Interventions: Behavioral: Brief Intervention; Behavioral: Common Elements Treatment Approach (CETA)

• Registration Number: NCT03966885
• Lead Sponsor: Columbia University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Study Start: 2019-06-24
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Results First Submitted: 2022-07-26
• Results First Submitted QC: 2022-08-18
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Results First Posted: 2022-09-13
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

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)

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Exclusion Criteria

• HIV negative
• Not receiving care at one of the study clinics
• Currently psychotic or actively suicidal
• Unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Intervention (BI)	Brief Intervention	30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit.
Brief Intervention + CETA	Brief Intervention	30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA.
Brief Intervention + CETA	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline.	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.
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	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.
Number of Participants With Any Recent Substance Use.	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.

Trial Locations

Locations (1)

Centre for infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia