Cervical Cancer Prevention for Black Adults

NCT ID: NCT04927494

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-06-20

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Black women cervical cancer screening

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

Group Type: EXPERIMENTAL

Health is Wealth: A Cervical Health Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Adebola Adegboyega

OTHER

Sponsor Role: lead

Responsible Party

Adebola Adegboyega

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Adebola Adegboyega, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36447190 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

K01CA251487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

60704

Identifier Type: -

Identifier Source: org_study_id