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NCT Number: NCT07515729

Raising Awareness of Colorectal Screening in American Indian Communities

This study focuses exclusively on American Indian individuals within their communities to enhance health equity and address a critical tribal health priority. American Indian populations experience some of the highest colorectal cancer (CRC) mortality rates in the nation. By conducting research within these communities, this study aims to improve early detection, prevention, and treatment strategies tailored to their specific needs. The findings will help develop targeted interventions to reduce CRC disparities and improve health outcomes for American Indian individuals.

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Key information

About this study

This study aims to close gaps in diagnostic follow-up for American Indian (AI) patients by identifying barriers and facilitators to receiving diagnostic colonoscopies, with a focus on social determinants of health (SDOH). Insights from this will guide an implementation science (IS) study evaluating a CRC Screening Navigator-led intervention to improve access. The primary outcome is the annual percentage change in AI adults (ages 45-75) with positive stool-based screens who complete a diagnostic colonoscopy within 60 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion for patient interviews: American Indian Men and Women eligible for services at OKCIC and IHS facilities. American Indian Men and Women aged 45 to 75 years who are eligible for colorectal cancer screening.
  • Inclusion for the provider/staff/leadership interviews: Adults (18 to 80 years old) who are employed by the participating clinic.
  • Inclusion for caregiver/community member interviews: Adults aged 18 and over who are caregivers for patients eligible for CRC screening. Community members who are aged 18 and over.

Exclusion criteria

  • Exclusion for patient interviews: Non-American Indian Men and Women and American Indian Men and Women that are not in the required age range for CRC screenings.
  • Exclusion for provider/staff/leadership interviews: Employees less than 18 years old or people not employed by the participating clinics.
  • Exclusion for caregivers/community members: People less than 18 years old, not a caregiver for a patient eligible for CRC screening. People less than 18 years old and not a member of the community where the participating clinics are located.

Treatment and study plan

Navigator-led intervention

Other

Navigator will review the proposed implementation plan with PCPs, clinic staff and administrators to address how diagnostic colonoscopy can fit smoothly within overall clinic operations.

Primary outcomes

  1. Effects of a clinical intervention on CRC diagnostic testing outcomes

    Time frame: 4 year

    Measures the percentage of screen-positive patients successfully navigated to diagnostic colonoscopy within 60 days. The study will use a Hybrid Type 2 pretest/posttest design. A pretest pilot (40 patients across all sites) will inform full-scale implementation, completed in Year 2 within six months. Full-scale implementation (252 patients) will run from Year 2, Month 7 to Year 4, Month 6, assessing pragmatic effectiveness and implementation outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Doescher, MD, MSPH

CONTACT

[email protected]

05-271-4808

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Indian Health Service (IHS)
  • Oklahoma City Indian Clinic

Registry information

Official study title

An American Indian Community-Engaged Approach to Increasing Diagnostic Colonoscopy

Acronym: AIC-DC

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 7, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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