Clinical trial NCT02720237: Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load
Official title: Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
HIV
Keywords: Alcohol use
HIV
Viral Load
ART
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Thai Nguyen Center for Preventive Medicine
name: Johns Hopkins University
First posted: 2016-03-25
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of two interventions \[a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention\], against each other and with an assessment-only control, in improving both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.

Detailed description: This study is a three-arm randomized controlled trial among hazardous and heavy drinking HIV-infected ART clinic clients in Thai Nguyen province, Vietnam. It compares the effects of two evidence-based, culturally adapted, behavioral interventions \[a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention\] both against each other and compared with an assessment-only standard of care arm, in order to understand the relative effectiveness of each intervention in reducing alcohol use and suppressing HIV viral load.

The Brief Intervention (BI) consists of 2 individual sessions and 2 booster phone sessions delivered by a trained counselor and is based on Project Treat. Content of BI sessions includes review of drinking patterns, harmful effects of drinking, and alcohol use behavior change strategies. The MET+CBT Intervention consists of 6 sessions delivered by a trained counselor. The MET+CBT Intervention uses a client-centered, motivational interviewing approach and focuses on skills-building for alcohol use behavior change, including drinking refusal skills, skills to cope with and manage cravings and triggers, and developing positive thoughts and attitudes. It also includes review of drinking patterns and harmful effects of drinking.

This study will also measure the incremental cost-effectiveness of each intervention as compared to current counseling services offered in ART clinics in Vietnam.

Investigators hypothesize that: 1) Each intervention will be more effective than an assessment-only arm on percent days alcohol abstinent and percent virally suppressed at the 12-month assessment; 2) The BI will be equivalently effective to the MET+CBT Intervention on percent days alcohol abstinent; 3) The effect of each intervention on alcohol abstinence and viral suppression will be mediated by alcohol use readiness to change and/or coping skills acquisition; 4) The MET+CBT Intervention will be more effective than the BI on alcohol abstinence and viral suppression separately among participants with more severe alcohol use, people who inject drugs, and participants with depressive symptoms; 5) The alcohol reduction interventions (BI and MET+CBT Intervention) will be highly cost-effective compared to assessment-only standard of care; and 6) The BI will be highly cost-effective relative to the MET+CBT Intervention.

Understanding the relative effectiveness of each intervention in improving both alcohol- and HIV-related outcomes will provide insight into the optimal application of alcohol programs in resource-limited settings.

Eligibility criteria: Inclusion Criteria:

* Currently a client on ART at the clinic
* Hazardous drinking, measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) instrument: AUDIT-C score \>= 4 for men, AUDIT-C score \>=3 for women
* Plan on residing in Thai Nguyen province for the next 24 months

Exclusion Criteria:

* Unwilling to provide informed consent
* Unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior
* Unwilling to provide locator information
* Currently participating in other HIV, drug use or alcohol programs or interventions

Primary outcomes:
measure: Alcohol use
timeFrame: 12 months
measure: HIV viral load
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants who report a high level of readiness to change for alcohol use reduction
timeFrame: 12 months
measure: Number of participants who report a high level of coping skills for alcohol abstinence
timeFrame: 12 months
Other outcomes:
measure: Cost-effectiveness of the alcohol reduction interventions
timeFrame: 3 months
measure: Health utility of the alcohol reduction interventions
timeFrame: 12 months
Locations:
city: Thai Nguyen
country: Vietnam
facility: Thai Nguyen Center for Preventive Medicine
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Vivian F Go, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hershow RB, Reyes HLMN, Ha TV, Chander G, Mai NVT, Sripaipan T, Dowdy DW, Latkin C, Hutton HE, Pettifor A, Maman S, Frangakis C, Go VF. Evaluating the effects of two alcohol reduction counseling interventions on intimate partner violence perpetration: secondary analysis of a three-arm randomized controlled trial among Vietnamese men with HIV. Addiction. 2021 Oct;116(10):2712-2723. doi: 10.1111/add.15496. Epub 2021 Apr 27.
citation: Go VF, Hutton HE, Ha TV, Chander G, Latkin CA, Mai NVT, Quynh BX, Nguyen V, Sripaipan T, Lancaster KE, Blackburn N, Hershow RB, Dowdy DW, Frangakis C. Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2017115. doi: 10.1001/jamanetworkopen.2020.17115.