Cervical Cancer Prevention for Black Adults

Sponsor
AdegboyegaA (Other)
Overall Status
Recruiting
CT.gov ID
NCT04927494
Collaborator
National Cancer Institute (NCI) (NIH)
60
1
1
31
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health is Wealth: A Cervical Health Program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Black women cervical cancer screening

Participants in this group with receive the Health is Wealth intervention.

Behavioral: Health is Wealth: A Cervical Health Program
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.

Outcome Measures

Primary Outcome Measures

  1. Completion of HPV self-sampling [Baseline]

    HPV self-sampling kit return

  2. Change in Cervical cancer Knowledge [6 months (Baseline, immediately post-test, 6 month follow up)]

    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.

  3. Change in HPV knowledge [6 months (Baseline, immediately post-test, 6 month follow up)]

    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.

  4. Change in Self-efficacy [6 months (Baseline, immediately post-test, 6 month follow up)]

    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.

  5. Change in perceived barriers to screening [6 months (Baseline, immediately post-test, 6 month follow up)]

    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

  1. Change in benefits [6 months (Baseline, immediately post-test, 6 month follow up)]

    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

  2. Change in susceptibility [6 months (Baseline, immediately post-test, 6 month follow up)]

    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

  3. Change in seriousness [6 months (Baseline, immediately post-test, 6 month follow up)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky Lexington Kentucky United States 40536

Sponsors and Collaborators

  • AdegboyegaA
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Adebola Adegboyega, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AdegboyegaA, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT04927494
Other Study ID Numbers:
  • 60704
  • K01CA251487
First Posted:
Jun 16, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AdegboyegaA, Assistant Professor, University of Kentucky
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022