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

Study Overview
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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.

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.

Official Title
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Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam

Conditions
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Alcohol Drinking, HIV

Intervention / Treatment
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* Behavioral: Brief Intervention
* Behavioral: Motivational Enhancement Therapy (MET) Intervention
* Behavioral: Cognitive Behavioral Therapy (CBT) Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Intervention<br>Brief Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the ART clinic | Behavioral: Brief Intervention<br>* 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.<br>* Other names: BI;|
| Experimental: MET+CBT Intervention<br>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 | Behavioral: Motivational Enhancement Therapy (MET) Intervention<br>* In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.<br>* Other names: MET;Behavioral: Cognitive Behavioral Therapy (CBT) Intervention<br>* In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.<br>* Other names: CBT;|
| No Intervention: Assessment-Only Control<br>Study assessment visits and standard of care from providers at the ART clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol use | Percent days abstinent from alcohol | 12 months | 
| HIV viral load | Percent HIV viral suppression | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who report a high level of readiness to change for alcohol use reduction | Readiness to change is assessed using a brief Readiness to Change questionnaire based on Rollnick et al. (1996), where response is captured using a 10-point Likert scale. | 12 months | 
| Number of participants who report a high level of coping skills for alcohol abstinence | Coping skills are assessed using the alcohol abstinence self-efficacy scale of DiClemente et al. (1994), where response is captured using a 10-point Likert scale. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol use, HIV, Viral Load, ART