Actively Recruiting
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 2nd HARP Pilot Intervention
Led by Yale University · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying people with HIV who currently use alcohol and take multiple medications to understand how alcohol, cannabis, and certain medications affect falls and thinking abilities. This pilot study focuses on how alcohol use combined with medications that impact brain function might increase risks of falls and cognitive problems. The study aims to evaluate a pharmacist-led counseling approach to help reduce alcohol use and manage medication risks safely. Participants will receive a brief intervention delivered by specially trained clinical pharmacists using an information, motivation, and behavioral skills approach combined with motivational interviewing. Before the intervention, participants complete alcohol use screenings and a home blood test for alcohol biomarkers. After enrollment, pharmacists will review participants' medications and schedule a counseling call to discuss alcohol and medication use, set goals, and develop a plan for safer use. Follow-up calls and surveys will assess progress and experiences, and a final blood test and survey will be completed six months later. Some participants will be invited to share feedback in interviews. During the study, participants will complete surveys about alcohol and cannabis use, medication effects, and readiness to change. They will perform home blood tests for alcohol markers twice and mail results to the lab. Researchers will also review medical records for medication data. The intervention sessions are recorded for quality checks. Study success will be measured by enrollment ability, intervention delivery, participant completion rates, comfort with study content, and acceptance of home testing. Participation lasts about nine months with ongoing support and monitoring.
CONDITIONS
Brief Title
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with HIV infection
- Visited a local VA site within the past year
- Have an AUDIT-C score indicating current alcohol use
- Taking 5 or more non-antiretroviral medications, including at least one neurocognitively active medication such as benzodiazepines, opioids, muscle relaxants, sleeping medications, or selective serotonin reuptake inhibitors
You will not qualify if you...
- Currently hospitalized (inpatient)
- Diagnosed with Alcohol Use Disorder in the past 12 months
- Test positive for moderate or severe Alcohol Use Disorder on the Alcohol Symptom Checklist during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Initial phone contact and verification calls
Duration - Up to 1 week
Participants complete enrollment including consent, baseline surveys, blood spot tests for alcohol use, and a medication reconciliation call with a VA clinical pharmacist.
1 to 2 phone calls
Duration - 1 day (single intervention call)
Participants receive a brief pharmacist-led behavioral intervention using the Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique to discuss alcohol and medication use and develop a personalized plan for change.
1 scheduled phone call
Duration - 4 weeks after intervention
Four weeks after the intervention call, participants have a check-in call with the clinical pharmacist to discuss progress on goals, motivators, and setbacks, and are reminded to complete and mail back a post-intervention survey and monitoring forms.
1 phone call and survey mailing
Duration - 6 months post intervention
Six months after the intervention, participants receive a second home test kit for alcohol use and complete a final survey about the intervention and feasibility, returning materials by mail. Some participants may be recontacted for qualitative interviews about their experience.
Home test kit and survey mailing with optional interview by phone or Microsoft Teams
Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
A
Amy C Justice, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here