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

NCT05560932 | Completed Results DMC

• 3 other identifiers: Justice 090622P01AA029545-03P01 AA029545-03 sub 9238
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Alcohol Use

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

HIV Medications and Alcohol Use

EXPERIMENTAL

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)

Interventions

IMB-motivational interviewing (MI) techniques (IMB-MI) BEHAVIORAL

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).

HIV Medications and Alcohol Use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

West Haven CT Veterans Administration

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Methods

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Amy C Justice, MD, PhD
• Organization: Yale University

amy.justice2@va.gov

203-932-5711

Study Officials

• Amy C Justice, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: March 6, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)