HIV and Alcohol Research Center Focused on Polypharmacy (HARP)
Primary Purpose
HIV, Alcohol Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMB-motivational interviewing (MI) techniques (IMB-MI)
Sponsored by
About this trial
This is an interventional prevention trial for HIV
Eligibility Criteria
Inclusion Criteria:
- participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies
- prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score >0)
Exclusion Criteria:
- Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)
Sites / Locations
- West Haven CT Veterans AdministrationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIV Medications and Alcohol Use
Arm Description
Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol
Outcomes
Primary Outcome Measures
Change in Bothersome Symptoms from baseline using the HIV Symptoms Index
The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Total score is derived by counting the number of bothersome symptoms.
Change in Phosphatidylethanol (PEth) Levels
Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.
Number of Medications Prescribed Post Intervention
The number of prescriptions prescribed post intervention will be assessed by phone contact, paper survey and electronic health record pharmacy data.
Secondary Outcome Measures
Full Information
NCT ID
NCT05560932
First Posted
September 26, 2022
Last Updated
July 7, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05560932
Brief Title
HIV and Alcohol Research Center Focused on Polypharmacy (HARP)
Official Title
HIV and Alcohol Research Center Focused on Polypharmacy (HARP)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Alcohol Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIV Medications and Alcohol Use
Arm Type
Experimental
Arm Description
Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol
Intervention Type
Behavioral
Intervention Name(s)
IMB-motivational interviewing (MI) techniques (IMB-MI)
Intervention Description
The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).
Primary Outcome Measure Information:
Title
Change in Bothersome Symptoms from baseline using the HIV Symptoms Index
Description
The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Total score is derived by counting the number of bothersome symptoms.
Time Frame
baseline, immediately post-intervention, 30 days post intervention
Title
Change in Phosphatidylethanol (PEth) Levels
Description
Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.
Time Frame
baseline and 30 days post intervention
Title
Number of Medications Prescribed Post Intervention
Description
The number of prescriptions prescribed post intervention will be assessed by phone contact, paper survey and electronic health record pharmacy data.
Time Frame
baseline and 30 days post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies
prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score >0)
Exclusion Criteria:
Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy C Justice, MD, PhD
Phone
203-932-5711
Ext
3541
Email
amy.justice2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy C Justice, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Haven CT Veterans Administration
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will not be shared by placing it in a data repository, but will be shared with those who submit a reasonable request .
Learn more about this trial
HIV and Alcohol Research Center Focused on Polypharmacy (HARP)
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