NCT05359913

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

April 7, 2022

Last Update Submit

April 28, 2022

Conditions

Keywords

Cervical cancerAfrican American WomenCancer Prevention

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

African American Women

EXPERIMENTAL
Behavioral: Cervical cancer podcast for African American women

Interventions

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.

African American Women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Chakema C Carmack, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 7, 2022

First Posted

May 4, 2022

Study Start

September 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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.