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Clinical Trials/NCT04927494
NCT04927494
Completed
N/A

Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants

Adebola Adegboyega1 site in 1 country60 target enrollmentJanuary 1, 2023
ConditionsCervical Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Adebola Adegboyega
Enrollment
60
Locations
1
Primary Endpoint
Completion of HPV self-sampling
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
June 20, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Adebola Adegboyega
Responsible Party
Sponsor Investigator
Principal Investigator

Adebola Adegboyega

Assistant Professor

University of Kentucky

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

Outcomes

Primary Outcomes

Completion of HPV self-sampling

Time Frame: Baseline

HPV self-sampling kit return

Change in Cervical cancer Knowledge

Time Frame: 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.

Change in HPV knowledge

Time Frame: 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.

Change in Self-efficacy

Time Frame: 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.

Change in perceived barriers to screening

Time Frame: 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 Outcomes

  • Change in benefits(6 months (Baseline, immediately post-test, 6 month follow up))
  • Change in susceptibility(6 months (Baseline, immediately post-test, 6 month follow up))
  • Change in seriousness(6 months (Baseline, immediately post-test, 6 month follow up))

Study Sites (1)

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