# 2/6 COMpAAAS U01: Observation Study

> **NIH NIH U01** · YALE UNIVERSITY · 2020 · $891,895

## Abstract

Summary
Among those with HIV infection (HIV+) on antiretroviral therapy (ART), polypharmacy is three times more
common than among those without infection and occurs 10 years earlier. Likely due to greater physiologic
frailty, polypharmacy (5+ chronic medications) among those with HIV is also associated with greater mortality.
Potentially inappropriate medications (PIMs) are those which likely cause more harm than benefit due to drug
interactions and adverse reactions and these increase with polypharmacy. While criteria for PIMs among 65+
year olds (Aging PIMs) are established, they have not been validated among HIV+ individuals. Further, ART
and alcohol use also increase PIMs. We do not know which non ART pharmacotherapies (co medications) are
helpful and which are actually harmful among HIV+ who drink. Conversely, HIV and alcohol use may also be a
barrier to receipt of helpful co medications. In the face of limited evidence, providers may be reluctant to treat
Alcohol Use Disorder (AUD) with medications among HIV+ individuals due to safety concerns. Further, alcohol
use is a relative contraindication for HCV treatment. As a result, drinkers may choose to under report alcohol
use to gain access to direct acting agents (DAAs) but may experience more harm and less benefit. We draw
on the rich, longitudinal clinical data in the Veterans Aging Cohort Study and enhance it with strategic
additional data collection and innovative techniques to correct for systematic error in measurement and
confounding by indication. We will quantify the impact of Aging, ART and Alcohol PIMs and of
pharmacotherapies for AUD and HCV on patient salient outcomes (PSOs) including mortality, hospitalization,
medically significant falls, bacterial pneumonia, and delirium to inform prioritization of medications and limit
harm from polypharmacy among HIV+ individuals. Our study is timely and innovative. Polypharmacy is the
norm, AUD is under treated, and DAAs for HCV have only recently become available. While others have
quantified PIMs, we will measure their actual impact on PSOs. We will also measure the benefit from
pharmacotherapy for AUD and HCV among HIV+ and uninfected individuals who drink. These studies will be
instrumental in the design of eHealth interventions facilitating personalized care and simplification of co
medications among HIV+ individuals (see U24s CHAMP & RIB).

## Key facts

- **NIH application ID:** 10003105
- **Project number:** 5U01AA020790-10
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Amy Caroline Justice
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $891,895
- **Award type:** 5
- **Project period:** 2011-09-10 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10003105

## Citation

> US National Institutes of Health, RePORTER application 10003105, 2/6 COMpAAAS U01: Observation Study (5U01AA020790-10). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10003105. Licensed CC0.

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