# Genetic Testing (APOL1) Decisional Support for Potential Living Kidney Donors

> **NIH NIH R01** · TEMPLE UNIV OF THE COMMONWEALTH · 2021 · $514,299

## Abstract

PROJECT SUMMARY
The identification of the Apolipoprotein L-1 or APOL1 gene as an indicator of increased likelihood of developing
chronic kidney disease has sparked a debate about point-of-care genetic testing for potential living kidney
donors. While integrating genetic testing into the medical evaluation of potential living donors benefits patients,
ensuring an informed, deliberative decision making process is paramount. The proposed study is premised on
a large body of research demonstrating that traditional SDM processes and interventions fail to meet the needs
of ethnic minority populations. Because SDM requires an informed patient to engage in the decision making
process, novel methods are needed to assure a full, accurate understanding of risks, benefits, implications and
alternate options. We propose a participatory approach to developing a decisional support tool for African
American potential donors as they consider genetic testing as part of their medical evaluation. Specifically, this
mixed-method study will conduct the formative research needed to develop and refine the tool. Up to 6 focus
group interviews will explore potential donors' preferences for shared decision making and understanding of
the risks, benefits and implications of genetic testing in the context of live kidney donation (Aim 1). The findings
will inform the design of a brief quantitative survey assessing potential donors' decision-making preferences,
communication style, and knowledge of and attitudes toward genetic testing, kidney transplantation and living
donation. The survey (N=500) will be the first to include the Best-Worst Scaling methodology to assess the
level of importance potential donors place on the risks and benefits of genetic testing as well as trade offs
between risks and benefits donors are willing to make (Aim 2). A draft of the tool will be created, using the
Ottowa Framwork as guide, to support African American patients and their families making decisions about
both living donor kidney transplants and genetic testing in this context. Additional modifications will be made
based on the findings of the focus group interviews and completed surveys. The tool will then be refined
iteratively over four rounds of testing in simulated consultations with standardized providers and four rounds
with a Delphi panel of transplant professionals (Aim 3). A Stakeholder Committee, comprised of transplant
professionals and previous and potential living donors, will provide ongoing feedback and guidance across all
study phases. In a subsequent R01, the fully-vetted, newly developed tool will be implemented and tested in
clinical settings using a randomized controlled design. If successful, the tool will optimize care for the
thousands of African American potential living kidney donors evaluated in the United States annually.

## Key facts

- **NIH application ID:** 10341558
- **Project number:** 1R01DK131016-01
- **Recipient organization:** TEMPLE UNIV OF THE COMMONWEALTH
- **Principal Investigator:** Heather Marie Gardiner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $514,299
- **Award type:** 1
- **Project period:** 2021-09-30 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10341558

## Citation

> US National Institutes of Health, RePORTER application 10341558, Genetic Testing (APOL1) Decisional Support for Potential Living Kidney Donors (1R01DK131016-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10341558. Licensed CC0.

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