HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1

Not Applicable

Completed

• Conditions: Alcohol Use; HIV
• Interventions: Behavioral: IMB-motivational interviewing (MI) techniques (IMB-MI)

• Registration Number: NCT05560932
• Lead Sponsor: Yale University

Brief Summary

This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-30
• Study Start: 2023-03-06
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies
• prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score >0)

Exclusion Criteria

• Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV Medications and Alcohol Use	IMB-motivational interviewing (MI) techniques (IMB-MI)	Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol

Primary Outcome Measures

Name	Time	Method
Change in Phosphatidylethanol (PEth) Levels	baseline and 30 days post intervention	Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.
Number of Medications Prescribed Post Intervention	baseline and 30 days post intervention	The number of prescriptions prescribed post intervention will be assessed by phone contact, paper survey and electronic health record pharmacy data.
Change in Bothersome Symptoms from baseline using the HIV Symptoms Index	baseline, immediately post-intervention, 30 days post intervention	The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Total score is derived by counting the number of bothersome symptoms.

Trial Locations

Locations (1)

West Haven CT Veterans Administration; 🇺🇸 West Haven, Connecticut, United States