NCT06513819 HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
| NCT ID | NCT06513819 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-01-15 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Amy C Justice, MD, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06513819 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06513819 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06513819 currently recruiting?
Yes, NCT06513819 is actively recruiting participants. Contact the research team at amy.justice2@va.gov for enrollment information.
Where is the NCT06513819 trial being conducted?
This trial is being conducted at West Haven, United States.
Who is sponsoring the NCT06513819 clinical trial?
NCT06513819 is sponsored by Yale University. The principal investigator is Amy C Justice, MD, PhD at Yale University. The trial plans to enroll 100 participants.
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