RecruitingPhase 1

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

United States100 participantsStarted 2025-01-15

Plain-language 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.

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Feasibility: Ability to meet enrollment target of 100 participants

Timeframe: Week -2 to Week 0

Feasibility: Ability to deliver the complete intervention

Timeframe: Week 3 and week 7

Feasibility:Percentage of Completion of Study Items

Timeframe: up to Month 9

Acceptability: comfort, comprehensibility/helpfulness of content

Timeframe: Week 7, Month 9 and Month 9,Week 3

Acceptability: acceptability of PEth tests

Timeframe: Week 7, Month 9 and Month 9,Week 3

Trial details

NCT IDNCT06513819

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Amy C Justice, MD, PhD

203-932-5711 amy.justice2@va.gov

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