title: The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial.
abstract: BACKGROUND
  Live donor kidney transplantation (LDKT), an optimal therapy for many patients with end-stage kidney disease, is underutilized, particularly by African Americans. Potential recipient difficulties initiating and sustaining conversations about LDKT, identifying willing and medically eligible donors, and potential donors' logistical and financial hurdles have been cited as potential contributors to race disparities in LDKT. Few interventions specifically targeting these factors have been tested.
  
  
  METHODS
  We report the protocol of the Talking about Living Kidney Donation Support (TALKS) study, a study designed to evaluate the effectiveness of behavioral, educational and financial assistance interventions to improve access to LDKT among African Americans on the deceased donor kidney transplant recipient waiting list. We adapted a previously tested educational and social worker intervention shown to improve consideration and pursuit of LDKT among patients and their family members for its use among patients on the kidney transplant waiting list. We also developed a financial assistance intervention to help potential donors overcome logistical and financial challenges they might face during the pursuit of live kidney donation. We will evaluate the effectiveness of these interventions by conducting a randomized controlled trial in which patients on the deceased donor waiting list receive 1) usual care while on the transplant waiting list, 2) the educational and social worker intervention, or 3) the educational and social worker intervention plus the option of participating in the financial assistance program. The primary outcome of the randomized controlled trial will measure potential recipients' live kidney donor activation (a composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) at 1 year.
  
  
  CONCLUSIONS
  The TALKS study will rigorously assess the effectiveness of promising interventions to reduce race disparities in LDKT.
  
  
  BACKGROUND
  NCT02369354.
authors.affiliation: Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, 27701, USA. tara.strigo@duke.edu.
authors.forename: Tara S
authors.initials: TS
authors.lastname: Strigo
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health and Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD, USA. pephraim@jhu.edu.
authors.forename: Patti L
authors.initials: PL
authors.lastname: Ephraim
authors.affiliation: Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, 27701, USA. iris.pounds@duke.edu.
authors.forename: Iris
authors.initials: I
authors.lastname: Pounds
authors.affiliation: Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institution and Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA. fbriggs3@jhmi.edu.
authors.forename: Felicia
authors.initials: F
authors.lastname: Hill-Briggs
authors.affiliation: Department of Social Work, Morgan State University, Baltimore, MD, USA. linda.darrell@morgan.edu.
authors.forename: Linda
authors.initials: L
authors.lastname: Darrell
authors.affiliation: Division of Nephrology, Duke University School of Medicine, Durham, NC, USA. matthew.ellis@dm.duke.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Ellis
authors.affiliation: Division of Transplantation, Duke University School of Medicine, Durham, NC, USA. debra.sudan@dm.duke.edu.
authors.forename: Debra
authors.initials: D
authors.lastname: Sudan
authors.affiliation: Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, MD, USA. hrabb1@jhmi.edu.
authors.forename: Hamid
authors.initials: H
authors.lastname: Rabb
authors.affiliation: Division of Transplantation, Johns Hopkins School of Medicine, Baltimore, MD, USA. dorry@jhmi.edu.
authors.forename: Dorry
authors.initials: D
authors.lastname: Segev
authors.affiliation: Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institution and Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA. naeyuh@jhmi.edu.
authors.forename: Nae-Yuh
authors.initials: NY
authors.lastname: Wang
authors.affiliation: Division of Transplantation, Johns Hopkins School of Medicine, Baltimore, MD, USA. mkaiser@jhmi.edu.
authors.forename: Mary
authors.initials: M
authors.lastname: Kaiser
authors.affiliation: Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, 27701, USA. margaret.falkovic@dm.duke.edu.
authors.forename: Margaret
authors.initials: M
authors.lastname: Falkovic
authors.affiliation: Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, 27701, USA. jlebov@email.unc.edu.
authors.forename: Jill F
authors.initials: JF
authors.lastname: Lebov
authors.affiliation: Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, 27701, USA. ebony.boulware@duke.edu.
authors.forename: L Ebony
authors.initials: LE
authors.lastname: Boulware
mesh_terms: D000293:Adolescent; D000328:Adult; D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D003144:Communication Barriers; D046148:Donor Selection; D005378:Financial Support; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology; D054625:Healthcare Disparities; D006801:Humans; D016030:Kidney Transplantation / Q000191:economics; D019520:Living Donors / Q000193:education* / Q000706:statistics & numerical data; D008875:Middle Aged; D010353:Patient Education as Topic; D012107:Research Design; D012947:Social Work; D009927:Tissue and Organ Procurement / Q000191:economics / Q000379:methods*; D055815:Young Adult