Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 50 and up

Pilot intervention for HIV patients focusing on alcohol use and medication effects

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

Run by Yale University · NCT06513819 · Data updated 2026-11-12

This study tests a new program to help HIV-positive patients who drink alcohol manage their medications better and reduce risks like falls and memory problems.

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Quick facts

PhasePhase 1
Study typeInterventional
Ages50 Years and up
SexAll
Enrollment100 (estimated)
SponsorYale University
Academic / other
Locations1 site (West Haven, Connecticut)
StatusRecruiting
StartedJanuary 15, 2025
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedSeptember 25, 2026
Trial IDNCT06513819 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are HIV-positive individuals who have consumed alcohol in the past month and are taking five or more non-ART medications with neurocognitive effects.

Probably not a fit

Patients who are currently hospitalized or have a recent diagnosis of Alcohol Use Disorder may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot intervention targets HIV-positive patients who consume alcohol and take multiple medications, particularly those with neurocognitive effects. The study involves a pharmacist-led intervention that includes medication reconciliation and assessments of alcohol use through self-administered tests. Participants will receive guidance on managing their medications and alcohol consumption to reduce the risk of falls and cognitive impairment. The approach combines motivational interviewing techniques to encourage behavioral changes.

Why it matters

Potential benefit: If successful, this intervention could help reduce falls and improve cognitive function in HIV patients who consume alcohol and take multiple medications.

How similar studies have gone: While this specific approach is novel, there is existing literature suggesting that interventions addressing alcohol use and medication management can be beneficial for similar populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • VA Connecticut Healthcare System
    West Haven, Connecticut, United States
    Recruiting

Study contacts

  • Principal investigator: Amy C Justice, MD, PhD — Yale University
  • Study coordinator: Amy C Justice, MD, PhD
  • Email: amy.justice2@va.gov
  • Phone: 203-932-5711

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.