HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions (WELL)
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WELL Program
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring hiv, aids, alcohol, health, knowledge, motivation, skills, behavior
Eligibility Criteria
Inclusion Criteria:
- HIV positive
- Recent alcohol use
Exclusion Criteria:
-
Sites / Locations
- University Medical Center New Orleans Infectious Disease Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
WELL Program
Standard of Care
Arm Description
Five-week treatment program that aims to improve knowledge, motivation, and skills. It is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.
Five-week standard of care program.
Outcomes
Primary Outcome Measures
Viral load
The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.
Secondary Outcome Measures
Full Information
NCT ID
NCT03238586
First Posted
July 31, 2017
Last Updated
February 18, 2020
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03238586
Brief Title
HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
Acronym
WELL
Official Title
HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
5. Study Description
Brief Summary
A clinical study for patients with HIV that investigates the best way to reduce HIV transmission risk, and to improve the overall health of people living with HIV/AIDS. Participants will complete four assessments over the course of one year and will be randomly assigned to a five-week treatment program.
Detailed Description
The main purpose of this research study is to investigate the best way to reduce HIV transmission risk and to improve the overall health of people living with HIV/AIDS. This study tests an intervention program that aims to improve knowledge, motivation, and skills. The intervention program is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
hiv, aids, alcohol, health, knowledge, motivation, skills, behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WELL Program
Arm Type
Experimental
Arm Description
Five-week treatment program that aims to improve knowledge, motivation, and skills. It is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Five-week standard of care program.
Intervention Type
Behavioral
Intervention Name(s)
WELL Program
Primary Outcome Measure Information:
Title
Viral load
Description
The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.
Time Frame
Change from baseline at 3 months, 6 months and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV positive
Recent alcohol use
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Molina, MD, PhD
Organizational Affiliation
Louisiana State University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center New Orleans Infectious Disease Services
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
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