Implementation of a culturally competentAPOL1genetic testing programme into living donor evaluation: A two-site, non-randomised, pre–post trial design
Authors: Smith Justin D , Agrawal Akansha , Wicklund Catherine , Duquette Debra , Friedewald John , Rasmussen Luke V , Gacki-Smith Jessica , Tandon S. Darius , Muhammad Lutfiyya N , Yancy Clyde W , Dong Siyuan , Cooper Matthew , Gilbert Alexander , Shetty Aneesha , Gordon Elisa J 
Published: May 2023

Introduction

While living donor (LD) kidney transplantation is the optimal treatment for patients with kidney failure, LDs assume a higher risk of future kidney failure themselves. LDs of African ancestry have an even greater risk of kidney failure post-donation than White LDs. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly usingAPOL1genetic testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counselling with LD candidates aboutAPOL1due to a lack of knowledge and skill in counselling. Without proper counselling,APOL1testing will magnify LD candidates’ decisional conflict about donating, jeopardising their informed consent. Given cultural concerns about genetic testing among people of African ancestry, protecting LD candidates’ safety is essential to improve informed decisions about donating. Clinical ‘chatbots’, mobile apps that provide genetic information to patients, can improve informed treatment decisions. No chatbot onAPOL1is available and no nephrologist training programmes are available to provide culturally competent counselling to LDs aboutAPOL1. Given the shortage of genetic counsellors, increasing nephrologists’ genetic literacy is critical to integrating genetic testing into practice.

Methods and analysis

Using a non-randomised, pre–post trial design in two transplant centres (Chicago, IL, and Washington, DC), we will evaluate the effectiveness of culturally competentAPOL1testing, chatbot and counselling on LD candidates’ decisional conflict about donating, preparedness for decision-making, willingness to donate and satisfaction with informed consent and longitudinally evaluate the implementation of this intervention into clinical practice using theReach,Effectiveness,Adoption,Implementation andMaintenance framework.

Ethics and dissemination

This study will create a model forAPOL1testing of LDs of African ancestry, which can be implemented nationally via implementation science approaches.APOL1will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve informed consent. This study involves human participants and was approved by Northwestern University IRB (STU00214038). Participants gave informed consent to participate in the study before taking part.

Trial registration

ClinicalTrials.gov Identifier:NCT04910867. Registered 8 May 2021,https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000AWZ6&selectaction=Edit&uid=U0001PPF&ts=7&cx=-8jv7m2

ClinicalTrials.gov Identifier:NCT04999436. Registered 5 November 2021,https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000AYWW&selectaction=Edit&uid=U0001PPF&ts=11&cx=9tny7v