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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06513819
Phase
PHASE1
Status
Recruiting
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Conditions

  • Alcohol Drinking
  • Cannabis Use
  • Fall
  • Hiv

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Pharmacist lead intervention
    Clinical pharmacists will be trained by a team with expertise in behavioral and HIV clinical care, and participate in a 10-hour training course with coaching sessions offered over the course of the study to ensure effective and consistent performance. Pharmacists will be guided by a manual designed to provide and walk them through the necessary skills to perform the pilot intervention easily and effectively. The manual will provide background information, study goals, and describe the critical components of the IMB-MI model and the HARP pilot interventions. An easy to follow, step-by-step approach to performing the intervention will be included. The study protocol to be followed by the clinical pharmacists will be included in the manual along with additional motivational and troubleshooting strategies. Systematic feedback regarding intervention fidelity will be provided by the Evaluation Team.

Primary Outcome Measure

Feasibility: Ability to meet enrollment target of 100 participants [ Time Frame: Week -2 to Week 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516-

Find similar trials in West Haven, CT

By condition
HIV
By specialty
Infectious disease
By research site
VA Connecticut Healthcare System· West Haven, CT

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