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OpenTrials
Completed

NCT Number: NCT04705363

A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans

This pilot study will explore the preliminary efficacy of a colorectal cancer (CRC) screening intervention delivered by Virtual Human Agents (VHAs). Seven hundred fifty participants aged 45 to 75 will be recruited through Qualtrics panels. The study examines how different levels of dialectal linguistic features willingness to be screened for colorectal cancer. Participants will be randomly assigned to interact with one of four VHA conditions: a VHA using non-dialectal linguistic features, a VHA with a low level of dialectal linguistic features integrated, a VHA with a high level of dialectal linguistic features integrated, or a text-only control condition. Following the interaction, participants will complete survey measures to assess perceived willingness to be screened.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qualtrics

Gainesville, Florida, 32611, United States

About this study

African Americans experience significant health inequities, including higher morbidity and mortality rates due to colorectal cancer (CRC) compared to White Americans. While the causes of these disparities are complex, regular screening can help reduce them. However, adherence to CRC screening guidelines remains low, particularly among African Americans.

One strategy to reduce CRC screening disparities is using strategic communication interventions to promote the fecal immunochemical test (FIT). FIT is a low-cost, non-invasive screening method that alleviates common patient barriers to CRC screening and is as effective as colonoscopy in reducing CRC incidence and mortality.

Tailored messaging interventions have been shown to improve CRC screening rates. However, two critical questions must be addressed before implementing tailored screening interventions within healthcare systems: (1) To what extent must message content be tailored to be effective? and (2) How can participants be effectively engaged?

This study builds upon an existing project that utilizes mobile Virtual Human Technology (VHT) to deliver tailored CRC screening messages. Virtual Human Agents (VHAs) provide a unique opportunity to customize communication strategies, including linguistic adaptation, to align with patient preferences. Such interventions can help mitigate CRC screening barriers such as cultural mismatch and low self-efficacy.

This study investigates explicitly the role of dialectal linguistic features in shaping willingness to be screened for CRC. The pilot study is exploratory in nature and seeks to examine the following aim: To assess how tailoring the dialectal variety of VHA speech affects willingness to be screened for CRC.

We aim to recruit 750 participants, each of whom will interact with a VHA that varies in speech style across four conditions: (1) non-dialectal linguistic features, (2) a low-level integration of dialectal linguistic features, (3) a high-level integration of dialectal linguistic features, or (4) a voiceless, text-only control. Following the interaction, participants will assess the VHA's credibility using survey-based measures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Out of guidelines for colorectal cancer screening
  • No fecal immunochemical test within the last 12 months
  • No colonoscopy within the last ten years)

Exclusion criteria

  • Must meet inclusion criteria

Treatment and study plan

High Dialectal

Behavioral

A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction.

Low Dialectal

Behavioral

A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction.

Non-Dialectal

Behavioral

A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction.

Text-only

Behavioral

A virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text.

Primary outcomes

  1. Intention to Talk to Doctor About Colorectal Cancer Screening

    Time frame: Immediately after the intervention, up to 1 hour

    Measure: Intention to talk to a doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: The virtual appointment made me want to discuss colon cancer screening options with my doctor.

    Participants will respond using three 5-point Likert scales that will be summed. The total score ranges from 3 to 15, with higher scores indicating a greater intention to discuss colorectal cancer screening with a healthcare professional. Mean scores closer to 3 reflect lower intention, while mean scores closer to 15 reflect higher intention.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2021
Registry last updated
Apr 18, 2025

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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