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Podcasting Cervical Cancer Prevention for AAW

Primary Purpose

Cervical Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical cancer podcast for African American women
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Cervical cancer, African American Women, Cancer Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • self-identify as African American
  • biological female sex
  • speak and read English
  • 18 years old or older
  • not currently or previously diagnosed with cervical cancer or cervix dysplasia

Exclusion Criteria:

• history of hysterectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    African American Women

    Arm Description

    Outcomes

    Primary Outcome Measures

    Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry)
    To observe whether the podcast video significantly changed perceptions of cervical cancer prevention. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive perceptions to cervical cancer prevention
    Pap test intentions: Do you intend to obtain a Pap cytology screening? (single item)
    To observe whether the podcast video significantly changed intentions to obtain a Pap cytology test. Item will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating greater intentions for cervical cancer screening.
    HPV vaccination intentions: Do you intend to get vaccinated for HPV? (single item)
    For women who are within the HPV vaccination age range: to observe whether the podcast video significantly changed their intentions to obtain a HPV vaccination. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive intentions toward HPV vaccination.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2022
    Last Updated
    April 28, 2022
    Sponsor
    University of Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05359913
    Brief Title
    Podcasting Cervical Cancer Prevention for AAW
    Official Title
    Proof of Concept and Feasibility in Podcasting Cervical Cancer Prevention for African American Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. While previous research has identified only a few social determinants that are specifically related to cervical cancer, there may be a host of additional social and cultural factors that contribute to a lack of preventative behavior. The overall objective of the proposed study is to gather preliminary data to determine whether the use of concept mapping methodology is useful in identifying unique sociocultural determinants of cervical cancer prevention behavior, and to pilot test the feasibility of a podcast video developed using the information garnered from the concept mapping procedure. It is hypothesized that the resulting podcast video will increase HPV knowledge and behavioral intentions. Proof of concept and feasibility are needed first, in determining the utility of both the methodology and media development procedures, as well as data on preliminary effect outcomes, before further investigation and program development.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer
    Keywords
    Cervical cancer, African American Women, Cancer Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    African American Women
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cervical cancer podcast for African American women
    Intervention Description
    The video podcast will deliver cervical cancer prevention messages using entertainment education and behavioral journalism, and film production techniques such as "talking head" video, interview, animations, & live-action skits. The research team will work closely with the production company in scripting the video vignettes and sequences, ensuring that video content reflects salient domains captured in the concept mapping research development phase of the study.
    Primary Outcome Measure Information:
    Title
    Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry)
    Description
    To observe whether the podcast video significantly changed perceptions of cervical cancer prevention. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive perceptions to cervical cancer prevention
    Time Frame
    To be measured immediately before film viewing and immediately after film viewing
    Title
    Pap test intentions: Do you intend to obtain a Pap cytology screening? (single item)
    Description
    To observe whether the podcast video significantly changed intentions to obtain a Pap cytology test. Item will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating greater intentions for cervical cancer screening.
    Time Frame
    To be measured immediately before film viewing and immediately after film viewing
    Title
    HPV vaccination intentions: Do you intend to get vaccinated for HPV? (single item)
    Description
    For women who are within the HPV vaccination age range: to observe whether the podcast video significantly changed their intentions to obtain a HPV vaccination. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive intentions toward HPV vaccination.
    Time Frame
    To be measured immediately before film viewing and immediately after film viewing

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: self-identify as African American biological female sex speak and read English 18 years old or older not currently or previously diagnosed with cervical cancer or cervix dysplasia Exclusion Criteria: • history of hysterectomy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chakema C Carmack, Ph.D.
    Phone
    713-743-6231
    Email
    ccarmack@central.uh.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Because this is a feasibility study with a very low sample size, the data is preliminary and it is not certain that the data will be appropriate or useful for public dissemination.

    Learn more about this trial

    Podcasting Cervical Cancer Prevention for AAW

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