NCT04927494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

June 8, 2021

Last Update Submit

June 24, 2025

Conditions

Cervical Cancer

Keywords

Cervical cancer screeningHPV self-samplingAfrican AmericanSub-Saharan African immigrants

Outcome Measures

Primary Outcomes (5)

  • Completion of HPV self-sampling

    HPV self-sampling kit return

    Baseline

  • 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.

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

  • 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.

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

  • 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.

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

  • 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

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

Secondary Outcomes (3)

  • 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 Arms (1)

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

Interventions

Health is Wealth: A Cervical Health ProgramBEHAVIORAL

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

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAnatomically female with a cervix.
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 36447190DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Adebola Adegboyega, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

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

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)