HIV and Alcohol Research Center Focused on Polypharmacy (HARP)

HIV Clinical Trial

Official title:

HIV and Alcohol Research Center Focused on Polypharmacy (HARP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560932
• Other study ID #: Justice 090622
• Secondary ID: P01AA029545
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: Amy C Justice, MD, PhD
• Phone: 203-932-5711
• Email: amy.justice2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• HIV

Intervention

Behavioral:
• IMB-motivational interviewing (MI) techniques (IMB-MI)
The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).

Locations

Country	Name	City	State
United States	West Haven CT Veterans Administration	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bothersome Symptoms from baseline using the HIV Symptoms Index	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.	baseline, immediately post-intervention, 30 days post intervention
Primary	Change in Phosphatidylethanol (PEth) Levels	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.	baseline and 30 days post intervention
Primary	Number of Medications Prescribed Post Intervention	The number of prescriptions prescribed post intervention will be assessed by phone contact, paper survey and electronic health record pharmacy data.	baseline and 30 days post intervention