HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Part of paid clinical trials in West Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT05560932
- Status
- Completed
Conditions
- Alcohol Use
- HIV
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IMB-motivational interviewing (MI) techniques (IMB-MI) — BEHAVIORALThe 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).
Study Details
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.
Key Dates
- Start date
- Mar 6, 2023
- Status verified
- Jun 2025
- Primary completion
- Jan 4, 2024
- Completion
- Jan 4, 2024
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: HIV Medications and Alcohol UseParticipants with HIV who take 5 or more medications and currently (within the past month) consume alcohol
Primary Outcome Measure
Enrollment to Assess Feasibility [ Time Frame: baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| West Haven CT Veterans Administration | West Haven | Connecticut | 06516 | - |
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