# Administrative Supplement - Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial

> **NIH NIH U01** · YALE UNIVERSITY · 2020 · $100,000

## Abstract

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). While we have successfully recruited 79 participants to date into the interventional arm (FIRST Trial), we
are currently behind targets. To address this problem and in the context of a newly fostered collaboration that
has developed between our team and Dr. Patricia Molina’s group at Louisiana State University Health Sciences
Center (LSUHSC) over the past year, we request an administrative supplement to cover salary support and
patient payments to create the required infrastructure at the HIV Outpatient Clinic at LSUHSC, directed by Dr.
Lauren Richey, as a new study site. Given the prevalence of unhealthy ...

## Key facts

- **NIH application ID:** 10050502
- **Project number:** 3U01AA020790-09S1
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Amy Caroline Justice
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $100,000
- **Award type:** 3
- **Project period:** 2020-01-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10050502

## Citation

> US National Institutes of Health, RePORTER application 10050502, Administrative Supplement - Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial (3U01AA020790-09S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10050502. Licensed CC0.

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