Community-led Navigation to Address Disparities in Mammography Among Native American Women

October 2, 2025 updated by: Johns Hopkins Bloomberg School of Public Health
The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). TEAM encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. Women will be randomized to receive TEAM or TEAM + Navigation. Navigation involves monthly 1:1 support from a Diné peer-navigator.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chinle, Arizona, United States, 86503
        • Recruiting
        • Navajo Nation Center for Indigenous Health
        • Contact:
          • Kristen Mitchell, MS
          • Phone Number: 928-674-5051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Self-identify as American Indian or Alaska Native (AIAN)
  • Identify as Female
  • Are 40-74 years of age
  • Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)
  • Live within 80 miles of CCHFC
  • Have not received a mammogram within the prior 12 months
  • Do not have a personal history of breast cancer
  • Are not planning to move in the next 6 months
  • Willing to be randomized

Exclusion Criteria:

  • Do not self-identify as American Indian or Alaska Native (AIAN)
  • Do not identify as Female
  • Are not 40-74 years of age
  • Are not a registered patient at CCHCF
  • Do not live within 80 miles of CCHCF
  • Have received a mammogram within the prior 12 months
  • Have a personal history of breast cancer
  • Are planning to move in the next 6 months
  • Unwilling to be randomized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TEAM
TEAM (Tablet-based Education to improve the Acceptance of Mammography)
Behavioral: TEAM
TEAM encompasses culturally tailored mammography education modules
Experimental: TEAM + Navigation
TEAM (Tablet-based Education to improve the Acceptance of Mammography) and Navigation (provision of 1:1 support from a Diné peer-navigator)
Behavioral: TEAM
TEAM encompasses culturally tailored mammography education modules
Behavioral: Navigation
Navigation is provision of 1:1 support from a Diné peer-navigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with mammography
Time Frame: 3 months post baseline
Mammography uptake within 3 months of referral
3 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Genentech Foundation

Investigators

  • Principal Investigator: Katie Nelson, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00031873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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