Recruiting
Phase 1

Polypharmacy

Sponsor:

Yale University

Code:

NCT06513819

Conditions

Hiv

Alcohol Drinking

Fall

Cannabis Use

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique

Study Details

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.

Conditions

Hiv

Alcohol Drinking

Fall

Cannabis Use

Study ID

NCT06513819

Start date

Jan 15, 2025

Status verified date

Jan, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Pharmacist lead intervention

Clinical pharmacists will be trained by a team with expertise in behavioral and HIV clinical care, and participate in a 10-hour training course with coaching sessions offered over the course of the study to ensure effective and consistent performance. Pharmacists will be guided by a manual designed to provide and walk them through the necessary skills to perform the pilot intervention easily and effectively. The manual will provide background information, study goals, and describe the critical components of the IMB-MI model and the HARP pilot interventions. An easy to follow, step-by-step approach to performing the intervention will be included. The study protocol to be followed by the clinical pharmacists will be included in the manual along with additional motivational and troubleshooting strategies. Systematic feedback regarding intervention fidelity will be provided by the Evaluation Team.

Interventions

Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique

Delivered by a clinical pharmacist who will employ IMB-MI in informational, participant-centered discussions in which the clinical pharmacist and the participant collaboratively discuss the harms of alcohol use (with or without concurrent use of cannabis) and polypharmacy (specifically neurocognitively active medications), the relationship of these exposures to fall risk and NCEs, and how to mitigate these harms. Together pharmacist and participant will develop a plan for change in alcohol and polypharmacy use, self-monitoring, medications of concern, symptoms, and any additional resources needed. The goal of the intervention being to help patients stop or decrease alcohol use and stop medications in situations where it is safe to do so and agreed upon by the primary provider (but substitutions will be made if necessary).

Primary outcome measure

  • Feasibility: Ability to meet enrollment target of 100 participants [ Time Frame: Week -2 to Week 0 ]
  • Feasibility: Ability to deliver the complete intervention [ Time Frame: Week 3 and week 7 ]
  • Feasibility:Percentage of Completion of Study Items [ Time Frame: up to Month 9 ]
  • Acceptability: comfort, comprehensibility/helpfulness of content [ Time Frame: Week 7, Month 9 and Month 9,Week 3 ]
  • Acceptability: acceptability of PEth tests [ Time Frame: Week 7, Month 9 and Month 9,Week 3 ]

Central Contacts and Locations

Central contacts

Amy C Justice, MD, PhD

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

Locations

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 06516

More Information

Sponsor

Yale University

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-01-15.