Cervical Cancer Prevention for Black Adults
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health is Wealth: A Cervical Health Program
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring Cervical cancer screening, HPV self-sampling, African American, Sub-Saharan African immigrants
Eligibility Criteria
Inclusion Criteria:
- Self-identify as Black woman (African American or Sub-Saharan African Immigrant)
- No pap smear within the last three years or no pap smear/HPV co-test within past five years
- Able to speak and write in English
- Reside in Kentucky
Exclusion Criteria:
- Do not self-identify as Black woman (African American or Sub-Saharan African Immigrant)
- History of hysterectomy
- History of cervical cancer
- Being pregnant
- Unable to speak and write in English
- Do not reside in Kentucky
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Black women cervical cancer screening
Arm Description
Participants in this group with receive the Health is Wealth intervention.
Outcomes
Primary Outcome Measures
Completion of HPV self-sampling
HPV self-sampling kit return
Change in Cervical cancer Knowledge
Cervical cancer awareness will be assessed with Likert style questions (strongly disagree-1 to strongly agree-5) from the cervical cancer awareness toolkit. Awareness of warning signs and risk factors will be assessed with a prompted checklist. This instrument has been found to be valid and reliable in multiple populations.
Change in HPV knowledge
Participants will complete 16 items assessing knowledge of HPV, 6 items about HPV testing, and 7 items about the vaccination. Response options included "True," "False," and "Don't know," with scoring allocating one point for each correct response, and zero points for incorrect or "Don't know" responses, summed across items, for a potential range of 0-29. This instrument has been found to be valid and reliable in multiple populations.
Change in Self-efficacy
Self-efficacy will be assessed with 10 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct. This is a well validated and reliable instrument.
Change in perceived barriers to screening
Barriers will be assessed with 14 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
Secondary Outcome Measures
Change in benefits
Benefits will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
Change in susceptibility
Susceptibility will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
Change in seriousness
Seriousness will be assessed with 7 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct.
Full Information
NCT ID
NCT04927494
First Posted
June 8, 2021
Last Updated
June 12, 2023
Sponsor
Adebola Adegboyega
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04927494
Brief Title
Cervical Cancer Prevention for Black Adults
Official Title
Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adebola Adegboyega
Collaborators
National Cancer Institute (NCI)
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
The goal of this study is to develop and pilot test an intervention, entitled Health is Wealth: A Cervical Health Program, designed to promote screening and reduce perceived barriers to Cervical Cancer (CC) screening.
Aim 1: Examine general awareness and cultural factors (fatalism, religiosity/spirituality, temporal orientation, medical mistrust, and acculturation) related to cancer control and prevention among African Americans (AA) and Sub Saharan African (SAI) Immigrants.
Aim 2: Examine the socioecological barriers and facilitators to CC screening and self-sampling to inform tailoring of an evidenced based cervical health program to promote CC screening.
Aim 3: Assess feasibility, acceptability, and preliminary efficacy in a pilot test of the Health is Wealth: A Cervical Health Program among 30 AA and 30 SAI women using quasi-experimental design.
This study will take place in 2 phases.
Detailed Description
In phase 1, the investigators will conduct a cross-sectional survey with 150 Black men and women to examine factors impacting cervical cancer screening. Also, as part of phase 1, Aim 2 employs focus groups and a quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. In phase 2, Aim 3 will assess feasibility, acceptability, and preliminary efficacy of the Health is Wealth: A Cervical Health Program intervention among 30 African American and 30 Sub-Saharan African immigrant women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer screening, HPV self-sampling, African American, Sub-Saharan African immigrants
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Black women cervical cancer screening
Arm Type
Experimental
Arm Description
Participants in this group with receive the Health is Wealth intervention.
Intervention Type
Behavioral
Intervention Name(s)
Health is Wealth: A Cervical Health Program
Intervention Description
Health is Wealth: A Cervical Health Program will be introduced in a one-time 2-hour educational session, participants will be given HPV self-sampling kits, and instructional sheet that visually depicts the steps for self-sampling. The program will be culturally tailored to increase self-efficacy and knowledge while simultaneously addressing perceived health beliefs associated with cervical cancer and barriers associated with cervical cancer screening and HPV self-sampling. Content will be delivered in a group format (about 10-15 participants) by lecture, demonstration, and interactive exercises.
Primary Outcome Measure Information:
Title
Completion of HPV self-sampling
Description
HPV self-sampling kit return
Time Frame
Baseline
Title
Change in Cervical cancer Knowledge
Description
Cervical cancer awareness will be assessed with Likert style questions (strongly disagree-1 to strongly agree-5) from the cervical cancer awareness toolkit. Awareness of warning signs and risk factors will be assessed with a prompted checklist. This instrument has been found to be valid and reliable in multiple populations.
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
Title
Change in HPV knowledge
Description
Participants will complete 16 items assessing knowledge of HPV, 6 items about HPV testing, and 7 items about the vaccination. Response options included "True," "False," and "Don't know," with scoring allocating one point for each correct response, and zero points for incorrect or "Don't know" responses, summed across items, for a potential range of 0-29. This instrument has been found to be valid and reliable in multiple populations.
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
Title
Change in Self-efficacy
Description
Self-efficacy will be assessed with 10 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct. This is a well validated and reliable instrument.
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
Title
Change in perceived barriers to screening
Description
Barriers will be assessed with 14 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
Secondary Outcome Measure Information:
Title
Change in benefits
Description
Benefits will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
Title
Change in susceptibility
Description
Susceptibility will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
Title
Change in seriousness
Description
Seriousness will be assessed with 7 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct.
Time Frame
6 months (Baseline, immediately post-test, 6 month follow up)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Anatomically female with a cervix.
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-identify as Black woman (African American or Sub-Saharan African Immigrant)
No pap smear within the last three years or no pap smear/HPV co-test within past five years
Able to speak and write in English
Reside in Kentucky
Exclusion Criteria:
Do not self-identify as Black woman (African American or Sub-Saharan African Immigrant)
History of hysterectomy
History of cervical cancer
Being pregnant
Unable to speak and write in English
Do not reside in Kentucky
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adebola Adegboyega, PhD
Phone
859-323-5196
Email
aoadeg2@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adebola Adegboyega, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adebola Adegboyega, PhD
Phone
859-323-5196
Email
aoadeg2@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cervical Cancer Prevention for Black Adults
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