Chronic Kidney DiseasesNCT04910867
APOL1 Genetic Testing Program for Living Donors
A study testing Components of Genetic Counseling, APOL1 genetic testing and EHR integration in people with Chronic Kidney Diseases and Apolipoprotein L1, run by Northwestern University at 2 sites in United States.
Trial summary
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Apolipoprotein L1, Kidney Transplantation
- What is being tested?
- Components of Genetic Counseling, APOL1 genetic testing and EHR integration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2021to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living kidney donor candidates who identify as African American/Black, Jamaican, Barbadian, Grenadian, Brazilian from Salvador Trinidadian, Panamanian, Honduran, Haitian, Garifunan, Palenque, Guyanese, Dominican, Peruvian, Belizean, and Native American, or state that they have African ancestry or are aware of having biologically-related family with African ancestry
- Living kidney donor candidates may be directed or non-directed donors
- Adults (ages 18+)
- English-speaking
- Cognitively intact individuals
- All genders
Who cannot join
- Individuals who do not identify as African American/Black and are not aware of having any biologically-related family with African ancestry and do not have African ancestry
- Only African Americans and people of African ancestry will be included because APOL1 risk variants are predominantly found in African Americans and people who have African ancestry.
- Pregnant women cannot be living kidney donors
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Medstar Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007
About this study
Official title: Integrating a Culturally Competent APOL1 Genetic Testing Program Into Living Donor Evaluation
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating.
No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice.
Read more
The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to:
- Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice
- Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
- Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent.
The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then 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 patient informed consent.
Read the detailed description
This project, "Integrating a culturally competent APOL1 genetic testing program into living donor evaluation," will integrate APOL1 testing into the evaluation of living kidney donor candidates of African ancestry. The study aims to reduce decisional conflict, improve preparedness for decision making, and increase satisfaction with informed consent for living donation for donor candidates at elevated risk of post-donation kidney failure. The APOL1 testing program will entail adapting established artificial intelligence conversational agents or "chatbots" to provide APOL1-specific information in preparation for donor candidates to undergo APOL1 testing, and adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve donor candidates' informed consent for living donation. APOL1 test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists. The study will involve community engagement to ensure that testing and counseling is delivered in a culturally competent manner.
Using a hybrid effectiveness-implementation design, this study will simultaneously evaluate the effectiveness and implementation of the APOL1 testing program to more efficiently translate evidence into practice, as service delivery system factors for adoption and scale up are considered while effectiveness is tested. The study will be conducted at two geographically distinct transplant programs: Northwestern University in Chicago, IL, and Georgetown University in Washington, DC.
Participants include live kidney donor candidates of African ancestry undergoing donor evaluation. The investigators will recruit potential participants consecutively; with participants recruited in year 1 serving as the control group, and participants recruited in years 2-5 serving as the intervention group. Participants will be eligible for participation if they respond positively to one of three questions assessing African ancestry. Participants in the intervention group will use the chatbot for 5-7 minutes. Immediately thereafter, research staff will ask for participants' informed consent to undergo APOL1 genetic testing; those who agree will provide a saliva sample for testing. APOL1 test results will be integrated into the respective transplant program's electronic health records. Thereafter, transplant nephrologists will engage in a counseling discussion with donor candidates about APOL1 and living donation.
Distributional assumptions will be assessed to evaluate appropriateness of model specifications. For primary analyses, the mixed model framework will allow for incorporation of a random center effect to separate within- and between-center variance estimates. As participants will not be randomized to intervention arms, the proposed statistical analysis plan will also incorporate a multivariable modeling approach, with inclusion of potential confounders, to reduce bias in intervention effect estimates. Effect estimates will be reported with confidence intervals to convey variability in estimates.
Methods for sample size estimates were based on a simplified comparisons of means between the two arms (pre-post implementation periods). Necessary sample sizes were then inflated to account for multivariable model and to account for loss-to-follow-up, to ensure adequate power. The proposed sample size of 74 participants in the control period and 316 in the intervention period will provide at least 80-90% power to detect meaningful differences in mean Decisional Conflict Scale (DCS) score ranging from 5.0 to 7.7 units.
The impact of this study will be the creation of a model for integrating genetic testing into clinical practice that shows how to scale up genetic counseling services through the use of chatbots to deliver foundational information, and training nephrologists to deliver components of genetic counseling. Specifically, this model will demonstrate how to deliver APOL1 testing of live donor candidates, which can then be implemented across the country via implementation science approaches. The proposed study will prepare transplant programs to deliver culturally competent counseling coterminous with the completion of the NIH APOLLO study in ~5 years. The findings generated from this research have the potential to protect donor candidates' safety by improving their informed consent. As such, this proposal is timely and responsive to the NIDDK Program Announcement (PA-18-330) "Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK."
- Being tested
- Components of Genetic Counseling, APOL1 genetic testing, EHR integration
- Keywords
- Genetics, Implementation research, Healthcare disparities, Ethics, Informed consent, Safety, African continental ancestry group, genetic counseling, Culturally competent care, Electronic health records, Decision support systems, clinical, Decision making, Live kidney donation, Shared decision making, Artificial intelligence, Surveys and questionnaires, Qualitative research, Clinical trial
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Components of Genetic CounselingBehavioural
The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation.
APOL1 genetic testingDiagnostic test
APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
EHR integrationOther
APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | No intervention will be administered. Usual care will be administered. |
| Intervention Arm | Experimental | APOL1 testing program Receives: Behavioral: Components of Genetic Counseling; Diagnostic Test: APOL1 genetic testing; Other: EHR integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS) (4 Time Points)
The Decisional Conflict Scale will measure donor candidates' perceived uncertainty in decision-making about donating and satisfaction with effective decision-making.
Scores range from: 0-100 Higher scores reflect greater decisional conflict (a worse outcome).
Measured: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Secondary outcomes (5)
Preparation for Decision Making Scale (PDMS) (Collected up to 3 Times) Scores Range From: Higher Scores Reflect Greater Preparation for Decision Making (a Better Outcome)
The Preparation for Decision Making Scale is a process measure that will assess donor candidates' perception of how useful the decision support intervention is in preparing them to communicate with their physician and make the donation about donating.
Scores range from: 0-100 Higher scores indicate higher perceived level of preparation for decision making
PDMS was collected from the Control arm at T4, and from the Intervention arm at T2, T3, T4.
Measured: T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Willingness to Donate (2-4 Time Points) Scores Range From: 0 to 10. Higher Scores Reflect Greater Willingness to Donate.
This scale will assess how willing donor candidates are to donate. Scores range from 1-10 Higher scores reflect greater willingness to donate Willingness was assessed at T1 and T4 for the control arm, an at T1, T2, T3, T4 for the intervention arm.
Measured: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Satisfaction With the Informed Consent Process - Quality of Decision-Making (2 Time Points)
This refers to donor candidates' satisfaction with the quality of decision-making.
Scores range from: 1 - 5 Higher scores reflect greater satisfaction with the informed consent process
This measure was assessed one time for the control arm (T4) and two times for the intervention arm (T3, T4).
Measured: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Satisfaction With the Informed Consent Process - Satisfaction With the Decision (2 Time Points)
This refers to donor candidates' satisfaction with the decision.
Scores range from: 1 - 5 Higher scores reflect greater satisfaction with the informed consent process
The control arm completed this measure one time at T4, and the intervention arm completed this measure two times, at T3 and T4.
Measured: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Satisfaction With the Informed Consent Process - Right Amount of Information Had Been Provided to Make a Decision (2 Time Points)
This refers to donor candidates' decision-making quality, decision satisfaction, and perception of information.
Scores range from: 1 - 5 Higher scores reflect greater satisfaction with the informed consent process
The control arm completed this measure one time at T4, and the intervention arm completed this measure two times, at T3 and T4.
Measured: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start9 Sep 2021
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A non-randomized, pre-post design. Data will be collected from participants at both sites during a control period, prior to implementing the intervention, and during an intervention period, under the proposed APOL1 genetic testing program.
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Principal investigator, Elisa Gordon, Vanderbilt University Medical Center
- Investigators
- Elisa J Gordon, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910867
- Sponsor's protocol ID
- R01DK128207
- Status last verified
- Aug 2026
- First submitted
- 8 May 2021
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith JD, Agrawal A, Wicklund C, Duquette D, Friedewald J, Rasmussen LV, Gacki-Smith J, Tandon SD, Muhammad LN, Yancy CW, Dong S, Cooper M, Gilbert A, Shetty A, Gordon EJ. Implementation of a culturally competent APOL1 genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design. BMJ Open. 2023 May 15;13(5):e067657. doi: 10.1136/bmjopen-2022-067657.
PubMed 37188469Rogers JL, Gacki-Smith J, Yacat R, Wicklund C, Duquette D, Friedewald J, Cooper M, Gilbert A, Agrawal A, Gordon EJ. Attitudes Toward Use of an APOL1 Genetic Testing Chatbot in Living Kidney Donor Evaluation: A Focus Group Study. Clin Transplant. 2024 Dec;38(12):e70026. doi: 10.1111/ctr.70026.
PubMed 39624929Gordon EJ, Gacki-Smith J, Gooden MJ, Waite P, Yacat R, Abubakari ZR, Duquette D, Agrawal A, Friedewald J, Savage SK, Cooper M, Gilbert A, Muhammad LN, Wicklund C. Development of a culturally targeted chatbot to inform living kidney donor candidates of African ancestry about APOL1 genetic testing: a mixed methods study. J Community Genet. 2024 Apr;15(2):205-216. doi: 10.1007/s12687-024-00698-8. Epub 2024 Feb 13.
PubMed 38349598Rasmussen LV, Agrawal AH, Botsford P, Powers A, Schnoebelen J, Xinos S, Harper G, Thanner J, McCabe S, Moore S, Wicklund CA, Duquette D, Gordon EJ. Challenges of Integrating APOL1 Genetic Test Results into the Electronic Health Record. Appl Clin Inform. 2023 Mar;14(2):321-325. doi: 10.1055/s-0043-1767680. Epub 2023 Apr 26.
PubMed 37186083Rasmussen LV, Agrawal AH, Gordon EJ. Transplant Nephrologists' Preferences for Clinical Decision Support for APOL1 Genetic Testing of Living Kidney Donors: A Focus Group Study. Kidney360. 2023 Nov 1;4(11):1610-1614. doi: 10.34067/KID.0000000000000265. Epub 2023 Oct 12.
PubMed 38032814Gordon EJ, Gacki-Smith J, Smith JD, Wicklund C, Duquette D, Muhammad LN, Dong S, Yevugah B, Anderson G, Friedewald J, Gilbert A, Tandon SD, Burgess-Bishop J, Fox M, Shuck M, Binion PA, Crawford V, Coleman C, Howard J, Agrawal A. Apolipoprotein L1 Genetic Testing and Counseling Does Not Reduce Living Kidney Donors' Willingness to Donate : A Hybrid Type 2 Nonrandomized Controlled Trial. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1222-1234. doi: 10.2215/CJN.0000001064. Epub 2026 Apr 20.
PubMed 42008800Merle JL, Kuo MC, Gacki-Smith J, Agrawal A, Friedewald J, Gordon EJ, Smith JD. Contextual factors of implementing APOL1 genetic testing into living kidney donor clinical evaluation. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2025 Jul;68(7):758-768. doi: 10.1007/s00103-025-04068-8. Epub 2025 Jun 11.
PubMed 40498120
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Culturally Competent APOL1 Genetic Testing Program Into Living Donor Evaluation
- ClinicalTrials.gov ID
- NCT04910867
- Acronym / sponsor ID
- R01DK128207
- Keywords
- Genetics, Implementation research, Healthcare disparities, Ethics, Informed consent, Safety, African continental ancestry group, genetic counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating.
No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice.
The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to:
- Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice
- Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
- Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent.
The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then 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 patient informed consent.
Detailed description
This project, "Integrating a culturally competent APOL1 genetic testing program into living donor evaluation," will integrate APOL1 testing into the evaluation of living kidney donor candidates of African ancestry. The study aims to reduce decisional conflict, improve preparedness for decision making, and increase satisfaction with informed consent for living donation for donor candidates at elevated risk of post-donation kidney failure. The APOL1 testing program will entail adapting established artificial intelligence conversational agents or "chatbots" to provide APOL1-specific information in preparation for donor candidates to undergo APOL1 testing, and adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve donor candidates' informed consent for living donation. APOL1 test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists. The study will involve community engagement to ensure that testing and counseling is delivered in a culturally competent manner.
Using a hybrid effectiveness-implementation design, this study will simultaneously evaluate the effectiveness and implementation of the APOL1 testing program to more efficiently translate evidence into practice, as service delivery system factors for adoption and scale up are considered while effectiveness is tested. The study will be conducted at two geographically distinct transplant programs: Northwestern University in Chicago, IL, and Georgetown University in Washington, DC.
Participants include live kidney donor candidates of African ancestry undergoing donor evaluation. The investigators will recruit potential participants consecutively; with participants recruited in year 1 serving as the control group, and participants recruited in years 2-5 serving as the intervention group. Participants will be eligible for participation if they respond positively to one of three questions assessing African ancestry. Participants in the intervention group will use the chatbot for 5-7 minutes. Immediately thereafter, research staff will ask for participants' informed consent to undergo APOL1 genetic testing; those who agree will provide a saliva sample for testing. APOL1 test results will be integrated into the respective transplant program's electronic health records. Thereafter, transplant nephrologists will engage in a counseling discussion with donor candidates about APOL1 and living donation.
Distributional assumptions will be assessed to evaluate appropriateness of model specifications. For primary analyses, the mixed model framework will allow for incorporation of a random center effect to separate within- and between-center variance estimates. As participants will not be randomized to intervention arms, the proposed statistical analysis plan will also incorporate a multivariable modeling approach, with inclusion of potential confounders, to reduce bias in intervention effect estimates. Effect estimates will be reported with confidence intervals to convey variability in estimates.
Methods for sample size estimates were based on a simplified comparisons of means between the two arms (pre-post implementation periods). Necessary sample sizes were then inflated to account for multivariable model and to account for loss-to-follow-up, to ensure adequate power. The proposed sample size of 74 participants in the control period and 316 in the intervention period will provide at least 80-90% power to detect meaningful differences in mean Decisional Conflict Scale (DCS) score ranging from 5.0 to 7.7 units.
The impact of this study will be the creation of a model for integrating genetic testing into clinical practice that shows how to scale up genetic counseling services through the use of chatbots to deliver foundational information, and training nephrologists to deliver components of genetic counseling. Specifically, this model will demonstrate how to deliver APOL1 testing of live donor candidates, which can then be implemented across the country via implementation science approaches. The proposed study will prepare transplant programs to deliver culturally competent counseling coterminous with the completion of the NIH APOLLO study in ~5 years. The findings generated from this research have the potential to protect donor candidates' safety by improving their informed consent. As such, this proposal is timely and responsive to the NIDDK Program Announcement (PA-18-330) "Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK."
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A non-randomized, pre-post design. Data will be collected from participants at both sites during a control period, prior to implementing the intervention, and during an intervention period, under the proposed APOL1 genetic testing program.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –No intervention will be administered. Usual care will be administered. |
| Intervention Arm | Experimental | Behavioral: Components of Genetic Counseling, Diagnostic Test: APOL1 genetic testing, Other: EHR integrationAPOL1 testing program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Living kidney donor candidates who identify as African American/Black, Jamaican, Barbadian, Grenadian, Brazilian from Salvador Trinidadian, Panamanian, Honduran, Haitian, Garifunan, Palenque, Guyanese, Dominican, Peruvian, Belizean, and Native American, or state that they have African ancestry or are aware of having biologically-related family with African ancestry
- Living kidney donor candidates may be directed or non-directed donors
- Adults (ages 18+)
- English-speaking
- Cognitively intact individuals
Key exclusion criteria (3 listed)
- Individuals who do not identify as African American/Black and are not aware of having any biologically-related family with African ancestry and do not have African ancestry
- Only African Americans and people of African ancestry will be included because APOL1 risk variants are predominantly found in African Americans and people who have African ancestry.
- Pregnant women cannot be living kidney donors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Components of Genetic CounselingThe APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent "chatbot" providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation. | Behavioural | Intervention Arm |
| APOL1 genetic testingAPOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating. | Diagnostic test | Intervention Arm |
| EHR integrationAPOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates. | Other | Intervention Arm |
Primary outcome
Decisional Conflict Scale (DCS) (4 Time Points)
Time frame: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
The Decisional Conflict Scale will measure donor candidates' perceived uncertainty in decision-making about donating and satisfaction with effective decision-making. Scores range from: 0-100 Higher scores reflect greater decisional conflict (a worse outcome).
5 secondary outcomes
Preparation for Decision Making Scale (PDMS) (Collected up to 3 Times) Scores Range From: Higher Scores Reflect Greater Preparation for Decision Making (a Better Outcome)
Time frame: T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Willingness to Donate (2-4 Time Points) Scores Range From: 0 to 10. Higher Scores Reflect Greater Willingness to Donate.
Time frame: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Satisfaction With the Informed Consent Process - Quality of Decision-Making (2 Time Points)
Time frame: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Satisfaction With the Informed Consent Process - Satisfaction With the Decision (2 Time Points)
Time frame: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Satisfaction With the Informed Consent Process - Right Amount of Information Had Been Provided to Make a Decision (2 Time Points)
Time frame: T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37188469Smith JD, Agrawal A, Wicklund C, Duquette D, Friedewald J, Rasmussen LV, Gacki-Smith J, Tandon SD, Muhammad LN, Yancy CW, Dong S, Cooper M, Gilbert A, Shetty A, Gordon EJ. Implementation of a culturally competent APOL1 genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design. BMJ Open. 2023 May 15;13(5):e067657. doi: 10.1136/bmjopen-2022-067657.
- Background: PubMed 39624929Rogers JL, Gacki-Smith J, Yacat R, Wicklund C, Duquette D, Friedewald J, Cooper M, Gilbert A, Agrawal A, Gordon EJ. Attitudes Toward Use of an APOL1 Genetic Testing Chatbot in Living Kidney Donor Evaluation: A Focus Group Study. Clin Transplant. 2024 Dec;38(12):e70026. doi: 10.1111/ctr.70026.
- Background: PubMed 38349598Gordon EJ, Gacki-Smith J, Gooden MJ, Waite P, Yacat R, Abubakari ZR, Duquette D, Agrawal A, Friedewald J, Savage SK, Cooper M, Gilbert A, Muhammad LN, Wicklund C. Development of a culturally targeted chatbot to inform living kidney donor candidates of African ancestry about APOL1 genetic testing: a mixed methods study. J Community Genet. 2024 Apr;15(2):205-216. doi: 10.1007/s12687-024-00698-8. Epub 2024 Feb 13.
- Background: PubMed 37186083Rasmussen LV, Agrawal AH, Botsford P, Powers A, Schnoebelen J, Xinos S, Harper G, Thanner J, McCabe S, Moore S, Wicklund CA, Duquette D, Gordon EJ. Challenges of Integrating APOL1 Genetic Test Results into the Electronic Health Record. Appl Clin Inform. 2023 Mar;14(2):321-325. doi: 10.1055/s-0043-1767680. Epub 2023 Apr 26.
- Background: PubMed 38032814Rasmussen LV, Agrawal AH, Gordon EJ. Transplant Nephrologists' Preferences for Clinical Decision Support for APOL1 Genetic Testing of Living Kidney Donors: A Focus Group Study. Kidney360. 2023 Nov 1;4(11):1610-1614. doi: 10.34067/KID.0000000000000265. Epub 2023 Oct 12.
- Results publication: PubMed 42008800Gordon EJ, Gacki-Smith J, Smith JD, Wicklund C, Duquette D, Muhammad LN, Dong S, Yevugah B, Anderson G, Friedewald J, Gilbert A, Tandon SD, Burgess-Bishop J, Fox M, Shuck M, Binion PA, Crawford V, Coleman C, Howard J, Agrawal A. Apolipoprotein L1 Genetic Testing and Counseling Does Not Reduce Living Kidney Donors' Willingness to Donate : A Hybrid Type 2 Nonrandomized Controlled Trial. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1222-1234. doi: 10.2215/CJN.0000001064. Epub 2026 Apr 20.
- Results publication: PubMed 40498120Merle JL, Kuo MC, Gacki-Smith J, Agrawal A, Friedewald J, Gordon EJ, Smith JD. Contextual factors of implementing APOL1 genetic testing into living kidney donor clinical evaluation. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2025 Jul;68(7):758-768. doi: 10.1007/s00103-025-04068-8. Epub 2025 Jun 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa J Gordon principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Components of Genetic Counseling, APOL1 genetic testing and EHR integration in people with Chronic Kidney Diseases and Apolipoprotein L1, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (DCS) (4 Time Points) (time frame: T1(baseline), T2 (1 week after APOL1 Testing, up to 2 months from baseline), T3 (1-2 days after APOL1 test result discussion, up to 6 months from baseline) and T4 (1 month after donation or after being ruled out as donor up to 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910867, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.