Pilot intervention for HIV patients focusing on alcohol use and medication effects
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT06513819 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are currently hospitalized or have a recent diagnosis of Alcohol Use Disorder may not benefit from this intervention.
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 performed: 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.
Eligibility criteria
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 this trial is running
West Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.