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HARP Pilot 2: Understanding Alcohol, Cannabis, and Medications in People with HIV

This study, called HARP Pilot 2, is looking at how alcohol use, cannabis use, and certain medications affect falls and thinking abilities in people living with HIV. Specifically, it focuses on those taking five or more non-HIV medications, especially ones that can affect the brain, like benzodiazepines or sleeping medications. The study will use a behavioral intervention called Information Motivation Behavioral and Motivational Interviewing (IMB-MI), delivered by a clinical pharmacist. The pharmacist will discuss the risks of alcohol and cannabis use, especially when combined with these other medications. The main goal is to see if it's possible to enroll 100 participants and successfully deliver this intervention. You might be able to join if you are 50 or older, have HIV, have recently visited a local VA, currently drink alcohol, and take five or more non-HIV medications, including one that affects the brain. People who are currently hospitalized or have an Alcohol Use Disorder (AUD) cannot participate.

Study design
This is an interventional study with a planned enrollment of 100 participants. The phase of the study is not specified.
What's involved
Before starting the intervention, you will be contacted by phone to verify alcohol use and provide verbal consent. You will also perform a self-administered blood spot test and have a brief call with a clinical pharmacist for a medication review. The intervention itself will be delivered by a clinical pharmacist.
Compensation
Not stated in the trial record.
Follow-up
Your completion of study items will be measured for up to 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06513819

HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)

Recruiting
PHASE1Ages 50+InterventionalPrevention
Yale University
~100 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility: Ability to meet enrollment target of 100 participants
Measured over Week -2 to Week 0
+4 more outcomes measured

Conditions

Hiv
Alcohol Drinking
Fall
Cannabis Use

Explore related trials

Alcohol use disorderHIV Infection

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Amy C Justice, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Amy C Justice, MD, PhD
[email protected]
203-932-5711 · ext. 3541
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

HIV+
have visited a local VA site in within the past year
had an AUDIT-C indicating current alcohol use
taking 5 or more non-ART medications, including an NCAM (i.e., benzodiazepines, opioids, muscle relaxants, sleeping medication, and selective serotonin reuptake inhibitors)

Exclusion

Inpatient individuals
Patients with an Alcohol Use Disorder (AUD) diagnosis in the past 12 months
Patients who test positive on the Alcohol Symptom Checklist for moderate or severe AUD during the screening process

What this trial measures

  • Feasibility: Ability to meet enrollment target of 100 participantsWeek -2 to Week 0

    Enrollment of 100 Participants: Week -2: Gather list of 100 eligible patients from the online VACS-HIV Index database; Send opt-out letter with study information and contact number. Week -2 to Week 0: Track patients for 2 weeks and note which have opted out. Week 0: Contact patients who have not opted-out; enroll, screen, and conduct medication reconciliation phone call; Send out pre-intervention package.

  • Feasibility: Ability to deliver the complete interventionWeek 3 and week 7

    Week 3: 1-hour intervention call between VA clinical pharmacist and participant Week 7: 30-minute booster call between VA clinical pharmacist and participant

  • Feasibility:Percentage of Completion of Study Itemsup to Month 9

    Percentage of completion of study items (Pre-Intervention Survey, Phosphatidylethanol Test, Post-Intervention Survey, 6-Month Post Intervention Survey, Phosphatidylethanol Test 2). Higher percentage indicates more completion of study items.

  • Acceptability: comfort, comprehensibility/helpfulness of contentWeek 7, Month 9 and Month 9,Week 3

    Assessed using a series of multiple-choice feedback and open-ended questions on Post-Intervention Survey and 6-Month Post Intervention Survey and a series of prompts on final semi-structured interview focused on feedback from participant

  • Acceptability: acceptability of PEth testsWeek 7, Month 9 and Month 9,Week 3

    Assessed using a series of multiple-choice feedback and open-ended questions on Post-Intervention Survey and 6-Month Post Intervention Survey and a series of prompts on final semi-structured interview focused on feedback from participant