NCT06513819 · Yale University
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
(HARP)
What this study is about
The focus of this pilot will be on falls and neurocognitive symptoms, and the impact of alcohol, cannabis use, and medications on these outcomes. The rationale is that alcohol use at any level may interact with neurocognitively active medications, alcohol, and cannabis use leading to falls and impaired cognition.
View original scientific description
The focus of this pilot will be on falls and neurocognitive symptoms, and the impact of alcohol, cannabis use, and medications on these outcomes. The rationale is that alcohol use at any level may interact with neurocognitively active medications, alcohol, and cannabis use leading to falls and impaired cognition.
Interventions
BEHAVIORAL
Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique
Delivered by a clinical pharmacist who will employ IMB-MI in informational, participant-centered discussions in which the clinical pharmacist and the participant collaboratively discuss the harms of alcohol use (with or without concurrent use of cannabis) and polypharmacy (specifically neurocognitively active medications), the relationship of these exposures to fall risk and NCEs, and how to mitigate these harms. Together pharmacist and participant will develop a plan for change in alcohol and polypharmacy use, self-monitoring, medications of concern, symptoms, and any additional resources needed. The goal of the intervention being to help patients stop or decrease alcohol use and stop medications in situations where it is safe to do so and agreed upon by the primary provider (but substitutions will be made if necessary).
Primary outcome measures
Feasibility: Ability to meet enrollment target of 100 participants
Time frame: Week -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 intervention
Time frame: Week 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 Items
Time frame: up 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 content
Time frame: Week 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 tests
Time frame: Week 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- West Haven, Connecticut
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations