Intervention for Hearing Health Among Native Americans (IHHANA)

April 9, 2026 updated by: University of California, San Francisco

The purpose of the study is to understand the cultural impact on hearing loss among Native Americans who traditionally rely on oral communication. This Native American community based participatory research hearing protection study proposes to implement a culturally relevant Talking Circles intervention to address hearing health inequities among Native Americans. The goal is to establish a sustainable culturally based Talking Circle (TC) hearing loss prevention program to disseminate messages, thus promote hearing health and improve access to preventive tools within the larger tribal community with high occupational and recreational noise exposure.

TC Participants will:

  • Complete a set of questionnaires (3 total) throughout the study.
  • Complete an audiometer hearing test with headphones, and watch one video computer related to hearing and how to protect hearing at the tribal wellness center.
  • In 6-months into the trial, participants will be asked to complete the same set of questionnaires from the beginning of the study.
  • In 12-months after the baseline surveys and hearing test, participants will be asked to complete the same set of questionnaires that were done at the beginning of the study and complete another hearing test by the computer.

The intervention will include facilitator training for local implementation and a delayed-intervention control to assess knowledge gains and protective behavior changes. Through use of the TC, the participants in the training program can use the support and insight from each other to be trained to establish self-sustaining hearing loss prevention program in the tribal community.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

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 Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464
        • United Keetoowah Band of Cherokee Indians

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

Yes

Description

Inclusion Criteria:

  • Native American tribal member; are age 18 years and older; may work in a noisy environment; and are willing to give informed consent to participate in the study. The study will include people without hearing loss and with hearing loss as well.

Exclusion Criteria:

  • Younger than the age of 18, non Native American tribal member and unwillingness to give informed consent.

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Talking Circle Intervention
Participants randomized to the experimental group will be clustered together geographically. This design will assist to minimize contamination. At baseline, the participants will complete assessment surveys and hearing tests in their tribal district community centers. All participants assigned to experimental group will receive the TCI immediately after baseline assessment and hearing test. Each TCI group includes 10 participants who will receive TCI together at a time and day that works the best.
Behavioral: Talking Circle
The TC intervention involves applying a tribal specific theory-based approach. The TCI is based within the Native Reliance theoretical model, which is a cultural identity construct that reflects the holistic worldview, values, beliefs, and behaviors within Native American culture. The community partnership community will assess and validate appropriate tribal language, community needs, and culturally content to be included in the TCI.
Other: Control group
Participants randomized to the control group will receive the delayed TCI after completing the 12-month follow up. Partcipants will receive the second hearing tests 12-months into the study and receive feedback on their hearing test results in comparison with the previous year's result. The control group will be asked to randomly participate in a focus group at the completion of the study.
Behavioral: Diabetes prevention program & delayed TC
The control group participants will receive the video/audio computer program on hearing, hearing loss, and diabetes prevention strategies. Participants will receive the delayed TCI after completing the 12-month follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of Noise-Induced Hearing Loss
Time Frame: Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests.
Knowledge of NIHL will be assessed by benefits and barriers (3-item and 6-item, 5-point Likert scales, respectively) of Use of Hearing Protection as reflecting declarative knowledge (factual), and self-efficacy (2-item, 5-point Likert scale) in Use of Hearing Protection as reflecting procedure knowledge (how to do).
Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests.
Use of Hearing Protections Devices (HPDs)
Time Frame: Data collected at baseline enrollment and at 6 and 12-month posttests.
Mean use of HPDs will be calculated using the participant's use of HPDs in percentage of the time (0%-100%) when in loud noise at two time points (the past three months and one month) measured at pretest and at 6 and 12-month posttests. As the two scores for the two time points are expected to show a strong correlation, the mean of two scores will be used as the outcome variable.
Data collected at baseline enrollment and at 6 and 12-month posttests.

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

National Institute of Nursing Research (NINR)
University of Texas at Austin

Investigators

  • Principal Investigator: Oi Saeng Hong, PhD, RN, FAAN, FAAOHN, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-42381
  • 1R01NR021182-01A1 (U.S. NIH Grant/Contract)

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

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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