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. 2023 May 15;13(5):e067657.
doi: 10.1136/bmjopen-2022-067657.

Implementation of a culturally competent APOL1 genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design

Justin D Smith  1   2 , Akansha Agrawal  3 , Catherine Wicklund  4 , Debra Duquette  3 , John Friedewald  3 , Luke V Rasmussen  5 , Jessica Gacki-Smith  6 , S Darius Tandon  7 , Lutfiyya N Muhammad  8 , Clyde W Yancy  9 , Siyuan Dong  10 , Matthew Cooper  11 , Alexander Gilbert  12 , Aneesha Shetty  13 , Elisa J Gordon  14
Affiliations

Implementation of a culturally competent APOL1 genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design

Justin D Smith et al. BMJ Open. .

Abstract

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 using APOL1 genetic testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counselling with LD candidates about APOL1 due to a lack of knowledge and skill in counselling. Without proper counselling, APOL1 testing 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 on APOL1 is available and no nephrologist training programmes are available to provide culturally competent counselling to LDs about APOL1. 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 competent APOL1 testing, 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 the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.

Ethics and dissemination: This study will create a model for APOL1 testing of LDs of African ancestry, which can be implemented nationally via implementation science approaches. APOL1 will 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.

Keywords: ETHICS (see Medical Ethics); End stage renal failure; GENETICS; Organisation of health services; QUALITATIVE RESEARCH; Renal transplantation.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Implementation research logic model. APOL1, Apolipoprotein L1; LD, living donor; NU, Northwestern University; GU, Georgetown University; CSAT, Clinical Sustainability Assessment Tool; RACE, Racial Attributes in Clinical Evaluation. Determinants are rated using Damschroder et al.’s (2013) coding system of the relative strength on a scale from –2 (strong negative impact), –1 (weak negative impact), 0 (neutral or mixed influence), 1 (weak positive impact), 2 (strong positive impact). Determinants are separated with a forward slash (/) to indicate ratings from each site (Northwestern/Georgetown). Superscripted letters indicate conceptual relationships between elements of the model ending with the implementation outcome. Note that not all determinants have an associated implementation strategy and not all strategies have a hypothesized mechanism; emphasis was placed on the causal paths associated with the study aims and hypotheses.
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