Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings

Study Overview
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Brief Summary
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Alcohol use is increasingly recognized as a key factor in morbidity and mortality among HIV-positive individuals and represents an important public health concern, given its associations with medication non-adherence, increases in viral load, poor immunologic outcomes (lower cluster of differentiation 4, or CD4, counts), drug resistance, lower health care utilization, comorbidities (HIV/viral hepatitis coinfection), and poor health outcomes overall. Adherence to HIV medications has a double public health benefit, both in terms of slowing disease progression and improving health outcomes among HIV-positive individuals and in helping to curb the sexual transmission of HIV. The objective of this study is to implement a multisite comparative effectiveness trial in real-world clinical settings with three intensities of treatment to test the clinical and cost effectiveness of an efficacious, theory-based behavioral intervention (PLUS) in improving adherence to antiretroviral therapy (ART) and alcohol-related outcomes among HIV-positive individuals who drink alcohol at harmful or hazardous levels. The study is being conducted in collaboration between the Center for HIV Educational Studies and Training (CHEST) at Hunter College at the City University of New York (CUNY) and the Spencer Cox Center for Health at the Institute for Advanced Medicine, Mount Sinai Health System.

Detailed Description
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Alcohol consumption at harmful or hazardous levels among HIV-positive persons exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) has been the single most important treatment for people living with HIV to optimize viral suppression and slow disease progression. Adherence to ART has considerable public health implications, particularly given that optimal adherence decreases morbidity and mortality, decreases the potential for the development of drug resistant strains of HIV, and reduces HIV infectiousness. Project PLUS (Positive Living through Understanding and Support) was the first (and to our knowledge only) theory-based behavioral intervention, which integrates motivational interviewing and cognitive-behavioral skills training, to demonstrate significant improvements in viral load, CD4 cell count, and self-reported adherence among a racially and ethnically diverse sample of HIV-positive women and men enrolled in a randomized controlled trial, and the first intervention for hazardous drinkers to demonstrate any significant effects. A clinic-based replication is the crucial next step in studying the intervention's effectiveness in the real world when delivered by HIV clinic providers to their patients. In collaboration with medical providers at the Spencer Cox Center for Health at the Institute for Advanced Medicine, Mount Sinai Health System, the largest provider of HIV medical care in the New York City area, our goals are to better understand alcohol-related outcomes among HIV-positive persons over the lifespan and to conduct a multisite comparative effectiveness trial with three intensities of treatment-the PLUS intervention, an enhanced treatment as usual (eTAU) condition, and treatment as usual (TAU) condition-to test the clinical and cost-effectiveness of the PLUS intervention in reducing alcohol use and improving ART adherence, viral load, and CD4 counts among HIV-positive hazardous drinkers. This study has the potential to exert a sustained and powerful impact on the effectiveness of ART interventions for HIV-positive persons with problematic drinking.

Official Title
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Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings

Conditions
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HIV, Alcohol Use, Medication Adherence

Intervention / Treatment
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* Behavioral: Immediate PLUS intervention
* Behavioral: Wait-list PLUS intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-positive Currently receiving ART Current viral load (VL) ˃200 copies/ml Report drinking at hazardous levels, operationalized as exceeding 14 standard drinks per week for men or exceeding 7 standard drinks per week for women, or reported use of illicit drugs exclusive of marijuana or illicit use of prescription opioids within the past 3 months. Exclusion Criteria: None

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Site 1 Immediate PLUS intervention<br>Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) | Behavioral: Immediate PLUS intervention<br>* The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.<br>|
| Active Comparator: Wait-list PLUS condition<br>Received the PLUS intervention at 12 months post baseline | Behavioral: Wait-list PLUS intervention<br>* In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.<br>|
| Experimental: Site 2 Immediate PLUS intervention<br>Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) | Behavioral: Immediate PLUS intervention<br>* The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.<br>|
| Experimental: Site 3 Immediate PLUS intervention<br>Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) | Behavioral: Immediate PLUS intervention<br>* The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load | Standard of care HIV-1 viral load results were run using local laboratories and results were abstracted from EMR data, indicating the participant's most recent viral load result. Each viral load result indicates the number of HIV copies in a milliliter (copies/mL), and raw values were log-transformed to deal with non-normal distribution. Minimum and maximum log-viral load values in the current sample were 1.28 and 6.07, respectively. | most recent result within past 90 days | 
| CD4 Count | CD4 results were accessed through clinic EMR data, and represent cells per cubic millimeter. | most recent result within past 90 days | 
| ART Medication Adherence | Percentage of antiretroviral medication (ART) doses that were taken as prescribed, within the past 30 days. Minimum and maximum values were 0% and 100%, respectively. | past 30 days | 
| Alcohol Use Severity | Severity of alcohol consumption as measured by the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a 10-item, widely-used screening questionnaire consisting of three questions related to drinking frequency, three questions on dependence, and four questions on problems caused by alcohol over the past three months. Scores range from 0 to 40, with higher scores indicating greater alcohol use. | past 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol use, hazardous drinking, behavioral intervention, ART adherence, viral load, CD4