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

August 26, 2026 updated by: Yale University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Additional outcomes were added at results entry.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enrollment to Assess Feasibility
Time Frame: baseline
Number of participants that enrolled and provided informed consent
baseline
Completion to Assess Feasibility
Time Frame: Study completion (Post-intervention Day 30)
Number of participants that completed the full pilot intervention
Study completion (Post-intervention Day 30)
Qualitative Interviews to Assess Feasibility
Time Frame: Study completion (within one to four weeks after Post-intervention Day 30)
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
Time Frame: baseline, post-intervention Day 1, Post-intervention Day 30
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.
Time Frame: baseline and Post-intervention Day 30
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
Time Frame: baseline, immediately post intervention (day 1) and Post-intervention Day 30
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
Time Frame: baseline, immediately post intervention (day 1) and Post-intervention Day 30
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
Time Frame: Post-intervention Day 30
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
Time Frame: Post-intervention Day 30
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
Time Frame: Post-intervention Day 30
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy C Justice, MD, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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