Protocol Title: Medications, Alcohol, and Substance use in HIV study (MASH): A substudy of the Veterans Aging Cohort Study (VACS)

PI: Amy Justice, MD, PhD

Abstract

1. Objective(s):

The objective of MASH is to collect additional observational data concerning the use of VA and non VA medications to inform our studies of the relationship between HIV disease, aging, mental and physical comorbidities, multisubstance use (MSU including alcohol, tobacco, and polypharmacy( prescription and nonprescription drugs) and adverse drug effects so that modifiable mediators of important patient outcomes (costs, utilization morbidity and mortality) might be targeted for intervention.

2. Research Design:

We propose to enroll a sample of patients with whom we will conduct an in depth observational study to document all medications taken (both from VA and non VA sources), medication side effects, and the patient’s desire to continue or discontinue certain medication. Our study includes an electronic survey completed by the patient; tissue sample collection (nails or hair, blood spot, and buccal swab) for detecting alcohol, tobacco and other substance use; and a telephone interview conducted by a pharmacist.

3. Methodology:

For the Full Study

We will recruit participants from eight VACS sites with a total target enrollment of 750 (Target 25 in West Haven pilot). Enrollment will be stratified by age (25% 65-75, 50% 50-64, and 25%<50 years of age). HIV+ on ART and taking at least one non ART medication).

Veterans that are hard of hearing will be excluded from the study.. Site coordinator will discuss the study with eligible VACS participants, collect written consent, enter participation into RedCap, collect a blood spot, nail or hair sample and a buccal swab and help the patient complete electronic survey. The telephone interview will be conducted by a pharmacist who will review all prescription medications from the VA and outside the VA, over the counter medications, herbal supplements, and dietary supplements. In addition, the Veteran will be asked about medication-related side effects, medication management, alcohol and substance use, and cognitive function. Patients participating in this study will be followed as part of VACS for patient salient clinical outcomes including hospitalization, progression of disease, and death.

Pilot Study

To insure the feasibility of our study, and in collaboration with Dr. Richard Sutton (Chief of ID at VA CT Healthcare System) and Steve Farber (PA in the ID clinic), we will conduct a pilot on 25 HIV positive subjects over 50 years of age at the VA CT Healthcare System. Subjects must be receiving ART and taking at least one non ART medication. We have obtained approval to approach specific patients for enrollment from Dr. Sutton. Steve Farber has agreed to serve as our site coordinator for the West Haven ID clinic. Participants will be compensated with a $50 dollar gift card upon completion of the study. Patients will be consented, complete the electronic survey, provide tissue samples (nail or hair, blood spot, and cheek swab), and participate in the telephone interview with the pharmacist.