Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
Sponsor Condition of Interest |
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The ENCIRCLE Trial
Edwards Lifesciences
Mitral Regurgitation
Mitral Valve Insufficiency
This study will establish the safety and effectiveness of the SAPIEN M3 System in
subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially
available surgical or transcatheter treatment options are deemed unsuitable.
Following completion of enrollment, subjects will... expand
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial. Type: Interventional Start Date: Nov 2020 |
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
Atrial Fibrillation
Stroke
Bleeding
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC)
to background antiplatelet therapy in patients who develop new-onset post-operative
atrial fibrillation (POAF) after isolated... expand
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Type: Interventional Start Date: Dec 2019 |
SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Abiomed Inc.
Acute Decompensated Heart Failure
Acute Heart Failure
Congestive Heart Failure
Heart Diseases
Safety and performance evaluation of the preCARDIA System for patients with ADHF. expand
Safety and performance evaluation of the preCARDIA System for patients with ADHF. Type: Interventional Start Date: Jul 2019 |
Gerofit and Cognition
VA Office of Research and Development
Aging
Cognitive Impairment
Physical Activity
Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia
prevalence increases with age, and with the increase in the population of people ages 65
and older, the total number of people with dementia is also increasing. Older Veterans
often have comorbid PTSD, major depression... expand
Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia prevalence increases with age, and with the increase in the population of people ages 65 and older, the total number of people with dementia is also increasing. Older Veterans often have comorbid PTSD, major depression and traumatic brain injury so that they are at 2 to 5 times the risk for cognitive impairment and dementia compared to the general population. There is evidence that exercise interventions in sedentary older adults could improve both physical and cognitive function. However, there have been very few studies on the effects of exercise on cognition in older Veterans and do not reflect the broader ethnic and health-status diversity of Veterans. Thus, improved knowledge of the role of exercise on cognition as well as the predictive power of biomarkers could have a major beneficial impact on Veterans' functional independence and quality of life. The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle biomarkers will predict these improvements. Type: Interventional Start Date: Apr 2024 |
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Ono Pharmaceutical Co. Ltd
Refractory Primary Central Nervous System Lymphoma
Primary CNS Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens
(methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/
vincristine)... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Type: Interventional Start Date: Dec 2021 |
A Peer-Led Intervention to Improve Postpartum Retention in HIV Care
University of Pennsylvania
HIV/AIDS
The purpose of this study is to test the efficacy of a theory-driven peer intervention
for pregnant and postpartum women living HIV. The peer intervention is designed to
increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy
in order to improve retention in care... expand
The purpose of this study is to test the efficacy of a theory-driven peer intervention for pregnant and postpartum women living HIV. The peer intervention is designed to increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to improve retention in care and viral suppression postpartum. The intervention will consist of face-to-face prenatal educational sessions, starting in early third trimester, and postpartum sessions scheduled up to three months postpartum. Type: Interventional Start Date: Mar 2020 |
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory...
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Recurrent B Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in
treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly
diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal
antibodies, such as inotuzumab ozogamicin... expand
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: May 2019 |
Coronary Microvascular Disease (CMD) Registry
Medstar Health Research Institute
Coronary Microvascular Dysfunction
The purpose of this project is to provide appropriate administrative and technical
supports for the warehousing and use of a database of patients with coronary
microvascular disease (CMD). This protocol will outline the process for identification
and capture of data, storage, as well as data use and... expand
The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes. Type: Observational Start Date: Feb 2023 |
Emicizumab in Patients with Acquired Hemophilia a
University of Washington
Acquired Hemophilia a
This is a phase II multicenter open-label, single-arm prospective study to evaluate the
efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds
in patients with acquired hemophilia A (AHA). expand
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA). Type: Interventional Start Date: Aug 2022 |
A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement...
Nuvalent Inc.
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and
tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the
antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other
advanced ROS1-positive solid tumors.
Phase... expand
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. Type: Interventional Start Date: Jan 2022 |
VItamin C in Thermal injuRY: The VICToRY Trial
Clinical Evaluation Research Unit at Kingston General Hospital
Shock
Thermal Burn
This study aims to show that giving high dose, intravenous vitamin C in addition to
standard care to burned critically ill patients will be associated with less organ
dysfunction, improved survival and a quicker rate of recovery. In this study, all
patients will receive standard care and of the patients... expand
This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo. Type: Interventional Start Date: Jul 2020 |
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Georgetown University
Thymoma
Thymic Carcinoma
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in
adult patients with advanced thymoma and thymic carcinoma after progressing on at least
one prior line of therapy.
The main question it aims to answer is:
• What is the overall response rate (ORR) in patients... expand
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy. The main question it aims to answer is: • What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma? Participants will: - receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity - have regular blood tests, scans, and examinations to monitor their health. - have blood and a biopsy of their tumor for research purposes. Type: Interventional Start Date: Apr 2024 |
Proglumide and Chemotherapy for Metastatic Pancreatic Cancer
Georgetown University
Metastatic Pancreatic Cancer
This is a Phase 2 study with an open labelled lead-in study to approximately treat 30
patients [6 subjects for Lead-in and 24 for Phase 2] enrolled with metastatic pancreatic
cancer with combination therapy using standard of care first line therapy with GEM-NAB-P
(GEM 1000mg/m2 IV and NAB-P 125 mg/m2... expand
This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients [6 subjects for Lead-in and 24 for Phase 2] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days, and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID. The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P. If 0 or 1 of a total of 6 patients at 400mg experiences a DLT, then we will proceed to the Phase 2 randomized trial. Type: Interventional Start Date: Jan 2024 |
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Synedgen, Inc.
Wound Heal
The purpose of this interventional study is to compare SynEx Wound Cleanser with the
current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating
or burn wounds who participate will be asked to attend up to four study visits, use the
assigned wound cleanser and complete... expand
The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing. Type: Interventional Start Date: Apr 2023 |
SELUTION4BTK Trial
MedAlliance, LLC
Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION
SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of
peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. expand
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. Type: Interventional Start Date: May 2022 |
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
Washington D.C. Veterans Affairs Medical Center
Chronic Kidney Diseases
Primary Objective:To study podocyte specific injury markers in African American Veterans
with non-diabetic kidney disease(NDKD), on empagliflozin therapy.
Primary Endpoint: Assess the effect of Empagliflozin on podocyte-specific proteins in
exosomes isolated from subjects' urine, such as nephrin,... expand
Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy. Primary Endpoint: Assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein. Secondary Objective: 1. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. 2. Correlate systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12) , hs-CRP and arterial stiffness measures with urine exosome-based podocyte protein estimation. 3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC) Type: Interventional Start Date: Feb 2024 |
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin...
National Cancer Institute (NCI)
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and
nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard
treatment alone in improving survival in patients with stage I and II classical Hodgkin
lymphoma. Brentuximab vedotin... expand
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone. Type: Interventional Start Date: May 2023 |
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
University of California, San Diego
Ulcerative Colitis
Crohn Disease
The purpose of this study is to compare the effectiveness and safety of a strategy of
switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target
of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel
disease (IBD) (Crohn's disease or ulcerative... expand
The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis [UC]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting. Type: Interventional Start Date: Oct 2022 |
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Children's Oncology Group
Ganglioneuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related to cancer. expand
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. Type: Observational Start Date: Nov 2000 |
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Edwards Lifesciences
Aortic Stenosis, Severe
The objective of this study is to establish the safety and effectiveness of the Edwards
SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific
aortic stenosis (AS). expand
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS). Type: Interventional Start Date: Jun 2022 |
Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy...
Medstar Health Baltimore
Heart Failure
Patient Acceptance of Health Care
The goal of this randomized clinical trial is to test the effect of patient education on
extent of use of guideline directed medical treatment (GDMT) of heart failure with
reduced ejection fraction. The main question that our study aims to answer is if patient
education can improve the adherence to... expand
The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital. Type: Interventional Start Date: Feb 2024 |
Fluoroquinolone Resistance Prevalence Study
Hackensack Meridian Health
Multiple Myeloma
This is an exploratory study to determine the prevalence of fluoroquinolone resistance in
patients receiving dose-intense melphalan with autologous peripheral blood stem cell
(PBSC) transplantation in the treatment of multiple myeloma (MM).
These data may be used in subsequent studies exploring... expand
This is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM). These data may be used in subsequent studies exploring the use of prophylaxis in this patient population. Type: Observational Start Date: Jul 2022 |
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung...
SWOG Cancer Research Network
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of the combination of ramucirumab and
pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell
lung cancer that is stage IV or that has come back after a period of improvement
(recurrent). Ramucirumab is a monoclonal antibody that... expand
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy. Type: Interventional Start Date: Mar 2023 |
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared with Placebo in Participants...
Organon and Co
Endometriosis
The purpose of this global Phase 2 study is to determine the efficacy, safety, and
tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years
of age (inclusive), who have moderate to severe endometriosis-related pain. expand
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain. Type: Interventional Start Date: Oct 2022 |
APOL1 Genetic Testing Program for Living Donors
Northwestern University
Chronic Kidney Diseases
Apolipoprotein L1
Kidney Transplantation
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... expand
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: 1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice 2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 3. 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. Type: Interventional Start Date: Sep 2021 |
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