# Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $409,209

## Abstract

The IGNITE (Implementing Genomics in Practice) Consortium was created to enhance the use of genomic
medicine by supporting the development of methods for incorporating genomic information into clinical care
and exploration of the methods for effective implementation, diffusion and sustainability in diverse clinical
settings. The IGNITE II grant was designed to establish the foundation for selected pragmatic clinical trials. As
part of the network funding, the Indiana University Clinical Group is recruiting participants into both the
ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) and GUARDD-US (Genetic
Testing to Understand and Address Renal Disease Disparities across the United States) clinical trials.
GUARDD-US: This trial aims to recruit African Americans with hypertension, with or without chronic kidney
disease, randomized to immediate versus delayed return of APOL1 genetic testing results. In those who are
APOL1 negative, we will also conduct a pilot study to test the impact of pharmacogenetic testing on systolic
blood pressure. Secondary outcomes include 6-month systolic blood pressure in chronic kidney disease
patients, medications ordered, renal diagnosis and testing, patient psycho-behavioral outcomes, cost
effectiveness, and the effect of pharmacogenetic-guided hypertension management on systolic blood pressure.
ADOPT-PGx: This randomized pragmatic genotype-guided clinical trial tests the effect of genotype-guided
therapy in three scenarios of patients: acute post-surgical pain, chronic pain, and depression. For each
scenario, participants are randomized to genotype-guided drug therapy versus usual approaches to drug
therapy selection. Changes in patient reported outcomes representing pain and depression control using
standard PROMIS scales define the primary endpoints. Secondary analyses include safety endpoints, changes
in overall well-being, and economic impact represented by differences in healthcare utilization.
The Administrative Supplement supports the continuation and conclusion of GUARDD-US and ADOPT-PGx.

## Key facts

- **NIH application ID:** 11073201
- **Project number:** 3U01HG010245-05S2
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Paul Dexter
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $409,209
- **Award type:** 3
- **Project period:** 2018-09-19 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11073201

## Citation

> US National Institutes of Health, RePORTER application 11073201, Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana. (3U01HG010245-05S2). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11073201. Licensed CC0.

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