Cervical Cancer Prevention for Black Adults

NCT04927494 | Completed Results

• 2 other identifiers: 60704K01CA251487
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Cervical cancer screening; HPV self-sampling; African American; Sub-Saharan African immigrants

Outcome Measures

Primary Outcomes (5)

• Number of Participants That Completed HPV Self-sampling

  HPV self-sampling kit return

  Baseline

• Change in Cervical Cancer Knowledge

  Cervical cancer awareness will be assessed with Likert style scale response choices: strongly disagree (scores 1 point), disagree (scores 2 points), neutral (scores 3 points), agree (scores 4 points) and strongly agree (scores 5 points). Awareness of warning signs and risk factors will be assessed with an 11 question prompted checklist. This instrument has been found to be valid and reliable in multiple populations. Scores range from 11-55. A higher score indicates greater cervical cancer knowledge.

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

• Change in Human Papillomavirus (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. A higher score indicates greater knowledge on HPV.

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

• Change in Self-Efficacy in Completing Pap Test

  Self-efficacy will be assessed with 10 items measured on a five-point Likert style scale response choices: strongly disagree (scores 1 point), disagree (scores 2 points), neutral (scores 3 point)s, agree (scores 4 points) and strongly agree (scores 5 points). Score ranges from 10-50. A higher score indicates a greater perceived ability to complete steps for a pap test. This is a well validated and reliable instrument.

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

• Change in Perceived Barriers to Screening

  Barriers to screening will be assessed with 14 items measured on a five-point Likert style scale response choices: strongly disagree (scores 1 point), disagree (scores 2 points), neutral (scores 3 points), agree (scores 4 points) and strongly agree (scores 5 points). Scores range from 14-70. A higher score indicates a greater perceived barrier to screening.

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

Secondary Outcomes (4)

• Change in Perceived Benefits of Pap Test

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

• Change in Perceived Susceptibility to Cervical Cancer

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

• Change in Perceived Seriousness to Cervical Cancer

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

• Change in Perceived Cervical Cancer Risk Factors

  6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

Study Arms (3)

Black women cervical cancer screening

EXPERIMENTAL

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

Behavioral: Health is Wealth: A Cervical Health Program

Phase 1 survey

OTHER

Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.

Behavioral: Health is Wealth: A Cervical Health Program

Phase 1 focus group

OTHER

Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.

Behavioral: Health is Wealth: A Cervical Health Program

Interventions

Health is Wealth: A Cervical Health Program BEHAVIORAL

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.

Black women cervical cancer screening; Phase 1 focus group; Phase 1 survey

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Anatomically female with a cervix.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adebola Adegboyega: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• Adegboyega A, Wiggins AT, Obielodan O, Dignan M, Schoenberg N. Beliefs associated with cancer screening behaviors among African Americans and Sub-Saharan African immigrant adults: a cross-sectional study. BMC Public Health. 2022 Nov 29;22(1):2219. doi: 10.1186/s12889-022-14591-x.

  PMID: 36447190 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Adebola Adegboyega
• Organization: University of Kentucky

aoadeg2@uky.edu

859-323-5196

Study Officials

• Adebola Adegboyega, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 16, 2021
• Study Start: January 1, 2023
• Primary Completion: May 10, 2025
• Study Completion: June 20, 2025
• Last Updated: July 31, 2026
• Results First Posted: July 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)