Chronic Kidney DiseasesNCT04999436
APOL1 Genetic Testing Program for Living Donors, Part 2
A study testing APOL1 Counseling Training Program in people with Chronic Kidney Diseases and Genetic Predisposition, 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, Genetic Predisposition
- What is being tested?
- APOL1 Counseling Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jul 2022to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults (age 18 years and older)
- English-speaking
- Transplant nephrologists evaluating live kidney donor candidates practicing at the study sites
- Not vision impaired
- Not cognitively impaired
Who cannot join
- Not a nephrologist
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
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 APOL1is 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 APOL1testing 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
Clinical practice guidelines advise "…considering APOL1 genotyping in live kidney donor candidates with sub-Saharan African ancestors" and using shared decision making until the NIH APOLLO study of APOL1 outcomes in living donors provides population-level data. Transplant physicians are increasingly adopting APOL1 testing. However, physicians do not consistently inform live donor candidates about APOL1, perform genetic counseling, or practice shared decision making with live donor candidates. Our prior research has shown that this variation results from lack of knowledge and skill in counseling about APOL1, and fear that APOL1 testing will deter live donor candidates from donating. It is unknown if they address African American live donor candidates' cultural concerns about genetic testing while counseling.
Effective counseling about APOL1 test results is critical especially because genetic information can magnify live kidney donor candidates' decisional conflict about donating. The consequences of such decisional conflict may be reduced donation rates, which could exacerbate disparities in African Americans patients' access to living donor kidney transplants and health outcomes. Therefore, effective culturally competent counseling is ethically essential to reduce live donor candidates' decisional conflict and enable informed decisions about donation.
This project will entail adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve live donor candidates' informed consent for living donation. The APOL1 counseling training program will address nephrologists' practical knowledge and counseling skill deficits about APOL1 as identified in our prior work. The specific duration and format of the counseling training program will be finalized through a final nephrologist needs assessment early in Year 1. Our preliminary needs assessment revealed a preference for a 2-4 hour educational program delivered by a genetics counselor through a live webinar format. The investigators plan to enroll all transplant nephrologists who evaluate live kidney donor candidates (n=6) across both sites for participation in the counseling training program.
The effectiveness of the nephrologist counseling training program will be assessed primarily by assessing increases in nephrologists' skill in delivering counseling for APOL1 by comparing the number and quality of prescribed counseling behaviors observed between nephrologists counseling live donor candidates in the control group (year 1) versus intervention group (years 2-5). Secondarily, we will evaluate the counseling training program via paired tests of pre-post scores of validated surveys assessing practical knowledge and skills in counseling. Additionally, we will qualitatively analyze nephrologists' perceptions of their APOL1 counseling over time.
Training materials will be updated after two years of implementing the APOL1 intervention based on lessons learned, and will be available for future dissemination. The findings generated from this research have the potential to meaningfully protect donor candidate safety by providing culturally competent counseling and shared decision making to improve candidates' informed consent. As such, we believe this proposal is both timely and responsive to the NIDDK Program Announcement (PA-18-330) "Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK."
- Conditions
- Chronic Kidney Diseases, Genetic Predisposition
- Being tested
- APOL1 Counseling Training Program
- Keywords
- Implementation science, Ethics, African continental ancestry group, Culturally competent care, Shared decision making, Genetic couseling, Informed consent, Nephrology, Educational intervention, Surveys and questionnaires, Apolipoprotein L1
- Medical subject headings
- Renal Insufficiency, Chronic, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOL1 Counseling Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Counseling Training Program | Experimental | 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. Receives: Behavioral: APOL1 Counseling Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and quality of prescribed Pre-Test counseling practices
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor kidney transplant candidates' about APOL1 testing, and living donation (before APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor).
The fidelity minimum and maximum values are: 0-12 Higher fidelity scores mean that the pre-test counseling discussion exhibited greater fidelity (adherence) to the training program.
The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
Measured: Post-intervention, up to 5 years
Number and quality of prescribed Post-Test counseling practices
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor candidates' about APOL1 test results and living donation (after APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor).
The minimum and maximum values are: 0-12 Higher fidelity scores mean that the post-test counseling discussion exhibited greater fidelity (adherence) to the training program.
The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
Measured: Post-intervention, up to 5 years
Secondary outcomes (12)
Practical Knowledge and Self-Efficacy in Genetic Counseling
Nephrologists' knowledge and self-efficacy or confidence in their ability to deliver APOL1 counseling will be assessed using a 12-item Likert scale survey. This is the Pre-Test.
The minimum and maximum values are: 1 to 5 Greater scores reflect greater knowledge or confidence with counseling.
Measured: Day 1
Practical Knowledge and Self-Efficacy in Genetic Counseling
Nephrologists' knowledge and self-efficacy or confidence in their ability to deliver APOL1 counseling will be assessed using a 12-item Likert scale survey. This is the Post-Test.
The minimum and maximum values are: 1 to 5 Greater scores reflect greater knowledge or confidence with counseling.
Measured: Approximately Day 14
Acceptability of Intervention Measure (AIM)
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Measured: Approximately Day 21
Acceptability of Intervention Measure (AIM)
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Measured: Approximately Month 2
Acceptability of Intervention Measure (AIM)
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Measured: Approximately Month 12
Intervention Appropriateness Measure (IAM)
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Measured: Approximately Day 21
Intervention Appropriateness Measure (IAM)
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Measured: Approximately Month 2
Intervention Appropriateness Measure (IAM)
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Measured: Approximately Month 12
Feasibility of Intervention Measure (FIM)
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Measured: Approximately Day 21
Feasibility of Intervention Measure (FIM)
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Measured: Approximately Month 2
Feasibility of Intervention Measure (FIM)
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program.
The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Measured: Approximately Month 12
Clinical Sustainability Assessment Tool (CSAT)
This 9-item Likert scale will assess nephrologists' perceptions of the sustainability of delivering APOL1 counseling according to the APOL1 counseling training program.
The minimum and maximum values are: 1 to 7 Higher scores indicate higher capacity for sustainability.
Measured: Approximately Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start19 Jul 2022
- Primary completion17 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will collect observational data to assess the impact of the training program on clinical practice. We will collect pre-test data before the intervention, and post-test data after the intervention.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Principal investigator, Elisa Gordon, Northwestern University
- Investigators
- Elisa J Gordon, PhD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999436
- Sponsor's protocol ID
- R01 DK128207 part 2
- Other IDs
- R01DK128207
- Status last verified
- Jul 2025
- First submitted
- 11 May 2021
- Last updated
- 15 Jul 2025
- Results posted
- No
- 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 37188469
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APOL1 Genetic Testing Program for Living Donors, Part 2
- ClinicalTrials.gov ID
- NCT04999436
- Acronym / sponsor ID
- R01 DK128207 part 2
- Conditions
- Chronic Kidney Diseases, Genetic Predisposition
- Keywords
- Implementation science, Ethics, African continental ancestry group, Culturally competent care, Shared decision making, Genetic couseling, Informed consent, Nephrology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
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 APOL1is 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 APOL1testing 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
Clinical practice guidelines advise "…considering APOL1 genotyping in live kidney donor candidates with sub-Saharan African ancestors" and using shared decision making until the NIH APOLLO study of APOL1 outcomes in living donors provides population-level data. Transplant physicians are increasingly adopting APOL1 testing. However, physicians do not consistently inform live donor candidates about APOL1, perform genetic counseling, or practice shared decision making with live donor candidates. Our prior research has shown that this variation results from lack of knowledge and skill in counseling about APOL1, and fear that APOL1 testing will deter live donor candidates from donating. It is unknown if they address African American live donor candidates' cultural concerns about genetic testing while counseling.
Effective counseling about APOL1 test results is critical especially because genetic information can magnify live kidney donor candidates' decisional conflict about donating. The consequences of such decisional conflict may be reduced donation rates, which could exacerbate disparities in African Americans patients' access to living donor kidney transplants and health outcomes. Therefore, effective culturally competent counseling is ethically essential to reduce live donor candidates' decisional conflict and enable informed decisions about donation.
This project will entail adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve live donor candidates' informed consent for living donation. The APOL1 counseling training program will address nephrologists' practical knowledge and counseling skill deficits about APOL1 as identified in our prior work. The specific duration and format of the counseling training program will be finalized through a final nephrologist needs assessment early in Year 1. Our preliminary needs assessment revealed a preference for a 2-4 hour educational program delivered by a genetics counselor through a live webinar format. The investigators plan to enroll all transplant nephrologists who evaluate live kidney donor candidates (n=6) across both sites for participation in the counseling training program.
The effectiveness of the nephrologist counseling training program will be assessed primarily by assessing increases in nephrologists' skill in delivering counseling for APOL1 by comparing the number and quality of prescribed counseling behaviors observed between nephrologists counseling live donor candidates in the control group (year 1) versus intervention group (years 2-5). Secondarily, we will evaluate the counseling training program via paired tests of pre-post scores of validated surveys assessing practical knowledge and skills in counseling. Additionally, we will qualitatively analyze nephrologists' perceptions of their APOL1 counseling over time.
Training materials will be updated after two years of implementing the APOL1 intervention based on lessons learned, and will be available for future dissemination. The findings generated from this research have the potential to meaningfully protect donor candidate safety by providing culturally competent counseling and shared decision making to improve candidates' informed consent. As such, we believe this proposal is both 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will collect observational data to assess the impact of the training program on clinical practice. We will collect pre-test data before the intervention, and post-test data after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Counseling Training Program | Experimental | Behavioral: APOL1 Counseling Training ProgramThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (age 18 years and older)
- English-speaking
- Transplant nephrologists evaluating live kidney donor candidates practicing at the study sites
- Not vision impaired
- Not cognitively impaired
Key exclusion criteria (1 listed)
- Not a nephrologist
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 |
|---|---|---|
| APOL1 Counseling Training ProgramThe 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. | Behavioural | Counseling Training Program |
Primary outcome
Number and quality of prescribed Pre-Test counseling practices
Time frame: Post-intervention, up to 5 years
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor kidney transplant candidates' about APOL1 testing, and living donation (before APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The fidelity minimum and maximum values are: 0-12 Higher fidelity scores mean that the pre-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
Number and quality of prescribed Post-Test counseling practices
Time frame: Post-intervention, up to 5 years
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor candidates' about APOL1 test results and living donation (after APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The minimum and maximum values are: 0-12 Higher fidelity scores mean that the post-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
12 secondary outcomes
Practical Knowledge and Self-Efficacy in Genetic Counseling
Time frame: Day 1
Practical Knowledge and Self-Efficacy in Genetic Counseling
Time frame: Approximately Day 14
Acceptability of Intervention Measure (AIM)
Time frame: Approximately Day 21
Acceptability of Intervention Measure (AIM)
Time frame: Approximately Month 2
Acceptability of Intervention Measure (AIM)
Time frame: Approximately Month 12
Intervention Appropriateness Measure (IAM)
Time frame: Approximately Day 21
Intervention Appropriateness Measure (IAM)
Time frame: Approximately Month 2
Intervention Appropriateness Measure (IAM)
Time frame: Approximately Month 12
Feasibility of Intervention Measure (FIM)
Time frame: Approximately Day 21
Feasibility of Intervention Measure (FIM)
Time frame: Approximately Month 2
Feasibility of Intervention Measure (FIM)
Time frame: Approximately Month 12
Clinical Sustainability Assessment Tool (CSAT)
Time frame: Approximately Month 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: 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.
- 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, PhD, MPH 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 APOL1 Counseling Training Program in people with Chronic Kidney Diseases and Genetic Predisposition, 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 5 inclusion and 1 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 15 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and quality of prescribed Pre-Test counseling practices (time frame: Post-intervention, up to 5 years). The study lists 2 primary outcomes in all. 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 NCT04999436, which also lists 1 linked publication.
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 15 Jul 2025.