Genetic Counseling Chatbot for Kidney Donors

No longer recruiting at 2 trial locations

Overseen By Jessica Gacki-Smith, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Not a nephrologist

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial helps African American kidney donor candidates make informed donation decisions using a new genetic counseling chatbot. The focus is on APOL1, a gene variant that raises the risk of kidney disease after donation, particularly in African Americans. The trial aims to enhance how doctors discuss APOL1 with potential donors, employing a culturally sensitive approach to reduce confusion or anxiety about the donation decision. Participation suits kidney specialists who work with African American donor candidates and seek to improve their genetic testing counseling skills through the APOL1 Counseling Training Program. As an unphased trial, this study provides a unique opportunity to contribute to research that can enhance counseling and decision-making for future kidney donors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this genetic counseling chatbot is safe for kidney donors?

In a previous study, researchers developed a program to teach doctors about APOL1 genetics and how to counsel patients on this topic. The training increased doctors' confidence and knowledge. Another study showed that having two APOL1 gene variants does not guarantee the development of kidney disease. The training program aims to equip doctors with clear and useful information to share with potential kidney donors.

The APOL1 counseling training is still new, so long-term data on its safety or effectiveness is limited. However, because it focuses on educating doctors, it does not involve any medicine or procedures that could directly risk patients. This makes it a low-risk option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the APOL1 Counseling Training Program because it aims to fill a critical gap in the care of kidney donors, especially those of African ancestry. Unlike standard genetic counseling that might not fully address cultural nuances, this program specifically trains transplant nephrologists to communicate effectively and sensitively with at-risk donor candidates. It leverages the expertise of genetic counselors and uses interactive modalities like webinars, which can make the training more engaging and practical. Overall, this approach could lead to more informed and culturally sensitive decision-making processes for kidney donation.

What evidence suggests that this counseling training program is effective for reducing decisional conflict in African American kidney donor candidates?

Research has shown that the APOL1 Counseling Training Program, the focus of this trial, increases kidney doctors' knowledge and confidence in discussing APOL1 genetic testing with potential kidney donors. Studies have found that this program helps doctors understand the importance of APOL1 testing and how to explain the results and their implications. It also addresses cultural concerns that African American donors might have about genetic testing. By enhancing these skills, the program aims to reduce uncertainty, enabling donors to make better-informed decisions about kidney donation. Overall, the program supports safer and more informed donation choices. ^{1 6 7 8 9}

Who Is on the Research Team?

Elisa J Gordon, PhD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who are not cognitively or vision impaired. It's specifically for transplant nephrologists evaluating live kidney donor candidates at the study sites, focusing on African American populations.

Inclusion Criteria

English-speaking

You do not have trouble seeing.

Doctors who evaluate people who want to donate a kidney at the study locations.

Exclusion Criteria

Not a nephrologist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Counseling Training Program

Transplant nephrologists undergo a 2-4 hour APOL1 counseling training program delivered by a genetic counselor through webinars and other interactive modalities.

2-4 hours

Implementation and Evaluation

The effectiveness of the APOL1 counseling training program is evaluated by assessing nephrologists' skills and knowledge in delivering counseling for APOL1, using pre-post tests and qualitative analysis.

5 years

Follow-up

Participants are monitored for safety and effectiveness after the intervention, focusing on nephrologists' counseling practices and live donor candidates' satisfaction with informed consent.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• APOL1 Counseling Training Program

Trial Overview

The trial tests a culturally adapted APOL1 genetic testing program with a chatbot named Gia and counseling training for nephrologists. It aims to improve decision-making and satisfaction among African American living kidney donors regarding donation risks.

How Is the Trial Designed?

Group I: Counseling Training Program Experimental Treatment 1 Intervention

The APOL1 counseling training program is designed for transplant nephrologists who evaluate live kidney donor candidates of African ancestry who are at risk for having APOL1 risk variants and kidney failure post-donation. The training program aims to increase transplant nephrologists' practical knowledge, self-efficacy, and skills in counseling live donor candidates about APOL1 in a culturally competent manner. The program will include training in: current APOL1 data; the value of APOL1 testing and meaning of positive test results for living donor clinical evaluation; risks of having two APOL1 gene variants on the donor's kidney health; how to engage in shared decision making about donation; how to address cultural concerns about genetic testing; and how to protect donor candidates' privacy and confidentiality with APOL1 test results. The APOL1 counseling training program will be delivered by a genetic counselor through webinars and other interactive modalities and last 2-4 hours.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Citations

1.

kidneymedicinejournal.org

kidneymedicinejournal.org/article/S2590-0595(25)00111-6/fulltext

Development and Evaluation of a Culturally Targeted ...

This report evaluated the effectiveness of the training program in increasing knowledge and self-efficacy in counseling about APOL1 genetic ...

2.

amjtransplant.org

amjtransplant.org/article/S1600-6135(25)01985-9/fulltext

Development and Evaluation of a Culturally Targeted ...

This multisite study developed and evaluated the effectiveness of a culturally targeted Counseling Training Program on APOL1 and Living Donation (“Program”).

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12254160/

Contextual factors of implementing APOL1 genetic testing ...

As part of the APOL1 Program, nephrologists are expected to discuss APOL1 test results and engage in shared decision-making about donation.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03615235

APOL1 Long-term Kidney Transplantation Outcomes ...

The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon ...

5.

kidneymedicinejournal.org

kidneymedicinejournal.org/article/S2590-0595(25)00111-6/pdf

A P

25. This report evaluated the effectiveness of the training program in increasing knowledge and self-efficacy in counseling about APOL1 genetic ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10186444/

Implementation of a culturally competent APOL1 genetic ...

We will assess practical knowledge and self-efficacy before and after the APOL1 counselling training programme via a 13-item survey, widely ...

7.

kidneymedicinejournal.org

kidneymedicinejournal.org/cms/10.1016/j.xkme.2025.101075/attachment/87d84802-054f-46c6-9e0a-4e2266c64935/mmc1.pdf

1 Item S1: Development of the APOL1 Counseling Training ...

If the APOL1 test results show 2 risk variants, it does not mean that the donor will develop kidney disease in the future.

8.

link.springer.com

link.springer.com/article/10.1007/s00103-025-04068-8

Contextual factors of implementing APOL1 genetic testing ...

This study evaluated the implementation of the APOL1 Genetic Testing and Counseling Program at two transplant centers to improve donors' informed decision- ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37188469/

Implementation of a culturally competent APOL1 genetic ...

Without proper counselling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardising their informed consent.