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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05359913
Other study ID # STUDY00003472
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date August 31, 2023

Study information

Verified date April 2022
Source University of Houston
Contact Chakema C Carmack, Ph.D.
Phone 713-743-6231
Email ccarmack@central.uh.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cervical cancer podcast for African American women
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Houston

Outcome

Type Measure Description Time frame Safety issue
Primary 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
To be measured immediately before film viewing and immediately after film viewing
Primary 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.
To be measured immediately before film viewing and immediately after film viewing
Primary 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.
To be measured immediately before film viewing and immediately after film viewing
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