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

Primary Purpose

HIV, Alcohol Use, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate PLUS intervention
Wait-list PLUS intervention
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring alcohol use, hazardous drinking, behavioral intervention, ART adherence, viral load, CD4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Site 1 Immediate PLUS intervention

Wait-list PLUS condition

Site 2 Immediate PLUS intervention

Site 3 Immediate PLUS intervention

Arm Description

Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)

Received the PLUS intervention at 12 months post baseline

Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)

Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)

Outcomes

Primary Outcome Measures

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.
CD4 Count
CD4 results were accessed through clinic EMR data, and represent cells per cubic millimeter.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2015
Last Updated
April 5, 2021
Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02390908
Brief Title
Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings
Acronym
PLUS
Official Title
Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
May 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Alcohol Use, Medication Adherence
Keywords
alcohol use, hazardous drinking, behavioral intervention, ART adherence, viral load, CD4

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Site 1 Immediate PLUS intervention
Arm Type
Experimental
Arm Description
Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)
Arm Title
Wait-list PLUS condition
Arm Type
Active Comparator
Arm Description
Received the PLUS intervention at 12 months post baseline
Arm Title
Site 2 Immediate PLUS intervention
Arm Type
Experimental
Arm Description
Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)
Arm Title
Site 3 Immediate PLUS intervention
Arm Type
Experimental
Arm Description
Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)
Intervention Type
Behavioral
Intervention Name(s)
Immediate PLUS intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-list PLUS intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Viral Load
Description
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.
Time Frame
most recent result within past 90 days
Title
CD4 Count
Description
CD4 results were accessed through clinic EMR data, and represent cells per cubic millimeter.
Time Frame
most recent result within past 90 days
Title
ART Medication Adherence
Description
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.
Time Frame
past 30 days
Title
Alcohol Use Severity
Description
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.
Time Frame
past 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyrel J Starks, PhD
Organizational Affiliation
Hunter College of City University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18077833
Citation
Parsons JT, Golub SA, Rosof E, Holder C. Motivational interviewing and cognitive-behavioral intervention to improve HIV medication adherence among hazardous drinkers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2007 Dec 1;46(4):443-50. doi: 10.1097/qai.0b013e318158a461.
Results Reference
background
PubMed Identifier
34537912
Citation
Starks TJ, Skeen SJ, Scott Jones S, Gurung S, Millar BM, Ferraris C, Ventuneac A, Parsons JT, Sparks MA. Effectiveness of a Combined Motivational Interviewing and Cognitive Behavioral Intervention to Reduce Substance Use and Improve HIV-Related Immune Functioning. AIDS Behav. 2022 Apr;26(4):1138-1152. doi: 10.1007/s10461-021-03467-7. Epub 2021 Sep 19.
Results Reference
derived

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

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