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CompletedNCT03276390HKTPUpdated Jul 2, 2026

A Culturally Targeted Transplant Program

An interventional study of Hispanic Kidney Transplant Program (HKTP) in ESRD, sponsored by Northwestern University. Completed at 4 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Northwestern University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
11,836
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Hispanic/Latino patients with end-stage renal disease are disproportionately less likely to get a kidney transplant, and specifically, a living donor kidney transplant (LDKT), compared to non-Hispanic whites. Accordingly, without LDKTs, Hispanics experience longer transplant waiting times, shorter patient and graft survival, and worse quality of life. Cultural beliefs and linguistic barriers contribute to the disparity in LDKTs. The objective of the proposed study is to implement and evaluate Northwestern Medicine's® Hispanic Kidney Transplant Program, a culturally-competent transplant center-based intervention, at two transplant centers serving large Hispanic populations. The proposed study will provide valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to increase Hispanic LDKTs nationally.

Read the detailed description

The shortage of organs for kidney transplantation for patients with end-stage renal disease (ESRD) is magnified in Hispanics/Latin Americans. Hispanics have a disproportionately higher prevalence of ESRD, yet receive fewer kidney transplants compared to non-Hispanic whites. Living donor kidney transplant (LDKT) is the treatment of choice for ESRD as it confers better patient and graft survival, shorter waiting time, and better quality of life than deceased donor kidney transplantation. However, compared to their representation on the waiting list, fewer Hispanics received a LDKT than non-Hispanic whites in 2013: 4% versus 10%. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and language barriers. The disparity will likely worsen without intervention as Hispanics are the largest and fastest growing minority group in the US.

Few available culturally competent interventions have led to increased LDKT rates. Interventions rarely address Hispanic cultural concerns, and there are no published models of transplant center-based only programs. The Chicago Northwestern Medicine's® Hispanic Kidney Transplant Program (HKTP), a culturally and linguistically competent program, has increased Hispanic LDKTs. The mean annual ratio of Hispanic to non-Hispanic white LDKTs grew from 0.20 in 2001-2006 to 0.34 in 2008-2013, a 70% increase (p\<0.001).

The objective of this study is to implement and evaluate the HKTP, a culturally-competent transplant center-based intervention, at two transplant centers serving large Hispanic populations (Dallas, TX, and Los Angeles, CA), with Northwestern University serving as the Study Coordinating Center. The pre-post HKTP intervention study will evaluate the effect of the HKTP's key culturally sensitive components (outreach, communication, education) on Hispanic LDKT rates, compared to matched controls. The specific aims are to:

  1. Implement the HKTP at two transplant centers by conducting a needs assessment of barriers and using a "learning collaborative" model to deliver HKTP protocols, scripts, and materials.
  2. Conduct a pre-post HKTP intervention evaluation with matched controls to assess if the HKTP is associated with an increase in: a) the ratio of Hispanic to non-Hispanic white LDKTs as a function of an absolute increase in Hispanic LDKTs, b) ESRD Hispanic patient additions to the waiting list, c) Hispanic potential donors per potential recipient, and d) Hispanic patients' satisfaction with care.
  3. Formatively evaluate the fidelity and innovative adaptations to HKTP's outreach, communication, and education at both study sites to identify effective components of the HTKP, using mixed methods.

As an exploratory aim, a budget impact analysis will be conducted to construct a business case for transplant centers and permit estimates of HKTP scalability. The proposed study will provide valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to increase Hispanic LDKTs nationally, improve health outcomes for Hispanics, and close the LDKT disparity gap.

02

Conditions studied

  • ESRD

Keywords

  • health disparities
  • living donation
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hispanic or non-Hispanic white potential recipients initiating evaluation for a transplant
  • age 18 or older
  • The above potential recipients' potential donors initiating evaluation for living donation

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11,836 participants (actual)

Study arms

  • Active comparator
    Intervention study site

    Exposure to the intervention, which is the Northwestern Medicine (TM) Hispanic Kidney Transplant Program, a culturally targeted program for Hispanic potential recipients for transplant evaluation that is implemented into the 2 study sites. The intervention study site will provide the intervention to its Hispanic patients. The intervention study will will also provide the routine care (control arm) to all other patients. For the purposes of this study, Hispanic potential recipients recruited into the study will be exposed to this intervention. Non-Hispanic Whites recruited into the study will not be exposed to this intervention.

    Behavioral: Hispanic Kidney Transplant Program (HKTP)

  • No intervention
    No intervention study site

    Exposure to routine transplant evaluation at the two control sites.

Interventions

  • BehavioralHispanic Kidney Transplant Program (HKTP)

    The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.

05

What researchers measure

Primary outcomes

  1. Ratio of Hispanic to non-Hispanic white LDKTs

    A center-level variable. This is a metric of disparity

    Time frame: Post-intervention exposure up to 3.5 years

Secondary outcomes

  1. Number of Hispanic living kidney donors

    A center-level variable. Exposure to the HKTP is expected to increase the number of Hispanic living kidney donors

    Time frame: Post-intervention exposure up to 3.5 years

  2. number of Hispanic ESRD patients added to the waiting list

    A center-level variable.

    Time frame: Post-intervention exposure up to 3.5 years

  3. number of Hispanic potential donors per potential recipient

    A center-level variable.

    Time frame: Post-intervention exposure up to 3.5 years

Other outcomes

  1. satisfaction with culturally competent care

    A center-level variable. The CAHPS survey questionnaire will be used. A mean level of satisfaction will be prospectively comparing routine care with culturally competent care.

    Time frame: in year 1-2 and year 4.5

06

Study locations

4 sites
  • Mayo Clinic Arizon
    Phoenix, Arizona 85054, United States
  • University of Colorado Denver
    Denver, Colorado 80045, United States
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
07

References and documents

Publications

  • Gordon EJ, Lee J, Kang RH, Caicedo JC, Holl JL, Ladner DP, Shumate MD. A complex culturally targeted intervention to reduce Hispanic disparities in living kidney donor transplantation: an effectiveness-implementation hybrid study protocol. BMC Health Serv Res. 2018 May 16;18(1):368. doi: 10.1186/s12913-018-3151-5. PubMed 29769080 ↗
  • Wang A, Caicedo JC, McNatt G, Abecassis M, Gordon EJ. Financial Feasibility Analysis of a Culturally and Linguistically Competent Hispanic Kidney Transplant Program. Transplantation. 2021 Mar 1;105(3):628-636. doi: 10.1097/TP.0000000000003269. PubMed 32282660 ↗
  • Gordon EJ, Romo E, Amortegui D, Rodas A, Anderson N, Uriarte J, McNatt G, Caicedo JC, Ladner DP, Shumate M. Implementing culturally competent transplant care and implications for reducing health disparities: A prospective qualitative study. Health Expect. 2020 Dec;23(6):1450-1465. doi: 10.1111/hex.13124. Epub 2020 Oct 9. PubMed 33037746 ↗
  • Gordon EJ, Uriarte JJ, Anderson N, Romo E, Caicedo JC, Shumate M. Implementation and modification of an organizational-level intervention: a prospective analysis. Implement Sci Commun. 2022 Jun 3;3(1):59. doi: 10.1186/s43058-022-00296-0. PubMed 35659156 ↗
  • Gordon EJ, Lee J, Kang R, Caicedo JC. Impact of having potential living donors on ethnic/racial disparities in access to kidney transplantation. Am J Transplant. 2022 Oct;22(10):2433-2442. doi: 10.1111/ajt.17090. Epub 2022 May 24. PubMed 35524363 ↗
  • Gordon EJ, Uriarte JJ, Lee J, Kang R, Shumate M, Ruiz R, Mathur AK, Ladner DP, Caicedo JC. Effectiveness of a culturally competent care intervention in reducing disparities in Hispanic live donor kidney transplantation: A hybrid trial. Am J Transplant. 2022 Feb;22(2):474-488. doi: 10.1111/ajt.16857. Epub 2021 Oct 17. PubMed 34559944 ↗
  • Alhalel N, Francone NO, Salazar AM, Primeaux S, Ruiz R, Caicedo JC, Gordon EJ. Patients' perceptions of a culturally targeted Hispanic Kidney Transplant Program: A mixed methods study. Clin Transplant. 2019 Jun;33(6):e13577. doi: 10.1111/ctr.13577. Epub 2019 May 23. PubMed 31034642 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03276390
Lead sponsor
Northwestern University
Collaborators
Mayo Clinic, Baylor Health Care System, University of Colorado, Denver, The Methodist Hospital Research Institute
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
Jan 18, 2017
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021
Last update
Jul 2, 2026

Study contacts

Elisa J Gordon, PhD
principal investigator · Northwestern University
Juan Carlos J Caicedo, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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