HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1

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.

Study Overview

• Status: Completed
• Conditions: HIV; Alcohol Use
• Intervention / Treatment: Behavioral: IMB-motivational interviewing (MI) techniques (IMB-MI)

Detailed Description

Additional outcomes were added at results entry.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • West Haven CT Veterans Administration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HIV Medications and Alcohol Use; Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol

Behavioral: IMB-motivational interviewing (MI) techniques (IMB-MI); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment to Assess Feasibility	Number of participants that enrolled and provided informed consent	baseline
Completion to Assess Feasibility	Number of participants that completed the full pilot intervention	Study completion (Post-intervention Day 30)
Qualitative Interviews to Assess Feasibility	Number of participants that successfully completed the qualitative interviews	Study completion (within one to four weeks after Post-intervention Day 30)
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. Presented here is the number of bothersome symptoms with improvement on post-intervention Day 1 and post-intervention Day 30.	baseline, post-intervention Day 1, Post-intervention Day 30
Number of Participants That Completed Both PEth Tests to Assess Acceptability.	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.	baseline and Post-intervention Day 30
Participants Readiness to Change Prescribed Medications	The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your medications?", "If your provider felt it was a good idea, how important is it for you to decrease your medications?", and "If your provider felt it was a good idea, how confident are you that you can decrease your medications?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.	baseline, immediately post intervention (day 1) and Post-intervention Day 30
Participants Readiness to Change Alcohol Use	The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your alcohol use?", "If your provider felt it was a good idea, how important is it for you to decrease your alcohol use?", and "If your provider felt it was a good idea, how confident are you that you can decrease your alcohol use?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.	baseline, immediately post intervention (day 1) and Post-intervention Day 30
Medication Use to Assess Acceptability	The number of respondents who reported they (1) felt comfortable with the way medication information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.	Post-intervention Day 30
Information Regarding PEth to Assess Acceptability	The number of respondents who reported that they (1) felt comfortable with the way PEth information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.	Post-intervention Day 30
General Feedback to Assess Acceptability	The number of respondents who (1) felt they learned new things about their health risk from alcohol, (2) learned new things about their health risk from polypharmacy, (3) learned how medications and alcohol can act together, and (4) felt that having a pharmacist to talk with was helpful. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.	Post-intervention Day 30

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Amy C Justice, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: Justice 090622; P01AA029545-03 (U.S. NIH Grant/Contract); P01 AA029545-03 sub 9238 (Other Grant/Funding Number: Sub Award P01 AA029545-03)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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 .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No