# NAVIGATE-Kidney: Reducing Type 1 Error Rate by Modifying Methods to Individually Randomized Group Treatment Trial

> **NIH NIH U01** · UNIVERSITY OF COLORADO DENVER · 2024 · $186,840

## Abstract

PROJECT SUMMARY/ ABSTRACT
Compared to non-Latinx White individuals, Latinx individuals (gender-inclusive term; includes Hispanics,
Latino/a/e) have 2-times the risk of kidney failure and face a disproportionate burden of structural racism and
kidney health disparities. Latinx individuals are less likely to receive pre-dialysis nephrology care compared to
non-Latinx White individuals and as a result, are less likely to initiate person-centered kidney replacement
therapy (KRT), such as kidney transplantation or home dialysis. Latinx individuals are instead more likely than
non-Latinx White individuals to begin KRT with a central venous catheter (CVC), which has a higher risk of
mortality (1.4-1.5-fold) and fatal infection (1.5-2-fold) compared to an arteriovenous fistula or graft. Our
community-partnered research team developed and tested NAVIGATE-Kidney, a multi-level, language and
culturally concordant community health worker (CHW) intervention for Latinx individuals with kidney failure who
receive maintenance hemodialysis. We hypothesize that our NAVIGATE-Kidney intervention will reduce the
composite primary endpoint, defined as time to transition to KRT and CVC use or death. Our funded parent
grant (U01 DK137272-01) allows us to move beyond dialysis center interventions by providing support to
Latinx individuals with chronic kidney disease stage 4. As part of the ERASE-KD consortium, the NAVIGATE-
Kidney protocol was reviewed by the NIH Office of Disease Prevention (ODP). The NIH ODP stated that this
study should be modified to an individually randomized group treatment (IRGT) trial to account for the
intraclass correlation (ICC) induced by the nesting of patients within the CHWs; otherwise, the analysis will
lead to an inflated type 1 error. The team modified the study design and it is now an IRGT; however, without
supplemental funding, we can only account for an ICC of 0. When clustering exists, it is very unlikely that the
ICC will be 0. To account for an ICC, we must increase our power by increasing the number of CHWs from 4
to 6. This will allow the team to detect a hazard ratio of 0.50 for a range of ICCs. There is no preliminary data
nor literature available to provide a reasonable estimate of the ICC of time to event endpoints of participants
with the same CHW for the population of our study. Findings from this IRGT will inform the ICC of future CHW
interventions including those interventions that are part of the ERASE-KD consortium. The team will work with
the ERASE-KD consortium and the NIH ODP to develop research methods for time-to-event IRGT. This
change constitutes an opportunity to advance kidney disease health equity science.

## Key facts

- **NIH application ID:** 11097650
- **Project number:** 3U01DK137272-02S2
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Lilia Cervantes
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $186,840
- **Award type:** 3
- **Project period:** 2023-09-01 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11097650

## Citation

> US National Institutes of Health, RePORTER application 11097650, NAVIGATE-Kidney: Reducing Type 1 Error Rate by Modifying Methods to Individually Randomized Group Treatment Trial (3U01DK137272-02S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11097650. Licensed CC0.

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