IMB-MI Technique for HIV

(HARP Trial)

Overseen By Amy C Justice, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must be taking: Benzodiazepines, Opioids, Muscle relaxants, SSRIs

Disqualifiers: Inpatient, Alcohol use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amy C Justice, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with HIV who also consume alcohol, may use cannabis, and are concerned about falling or cognitive symptoms. Participants should be using medications that could interact with their alcohol or cannabis use.

Inclusion Criteria

HIV+

Have visited a local VA site within the past year

Had an AUDIT-C indicating current alcohol use

Exclusion Criteria

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

I am currently hospitalized.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (phone call)

Enrollment and Pre-Intervention

Participants are enrolled, screened for alcohol use, and complete medication reconciliation

2 weeks

1 visit (phone call), home test kit sent

Intervention

Participants receive a pharmacist-led intervention focusing on alcohol use and medication management

4 weeks

1 visit (phone call)

Follow-up

Participants are monitored for progress and complete post-intervention surveys

6 months

1 visit (phone call), home test kit sent

Qualitative Interviews

Participants provide feedback on the intervention through qualitative interviews

1 month

1 visit (phone call or Microsoft Teams)

Treatment Details

Interventions

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

Trial Overview The study tests the Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique to see if it can reduce falls and improve neurocognitive function in people mixing alcohol, cannabis, and certain medications.

Participant Groups

Group I: Pharmacist lead intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+