Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcohol Drinking HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Brief Intervention

Brief Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the ART clinic

Group Type EXPERIMENTAL

Brief Intervention

Intervention Type BEHAVIORAL

In-person individual sessions (occurring one month apart) and booster phone sessions (occurring 2-3 weeks after each in-person session), delivered by a trained counselor.

MET+CBT Intervention

MET+CBT Intervention (6 in-person sessions and 3 optional group sessions), study assessment visits, and standard of care from providers at the ART clinic

Group Type EXPERIMENTAL

Motivational Enhancement Therapy (MET) Intervention

Intervention Type BEHAVIORAL

In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

Cognitive Behavioral Therapy (CBT) Intervention

Intervention Type BEHAVIORAL

In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

Assessment-Only Control

Study assessment visits and standard of care from providers at the ART clinic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief Intervention

In-person individual sessions (occurring one month apart) and booster phone sessions (occurring 2-3 weeks after each in-person session), delivered by a trained counselor.

Intervention Type BEHAVIORAL

Motivational Enhancement Therapy (MET) Intervention

In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (CBT) Intervention

In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

Intervention Type BEHAVIORAL

Other Intervention Names

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BI MET CBT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No