Cervical CancerNCT04927494

Cervical Cancer Prevention for Black Adults

A study testing Health is Wealth: A Cervical Health Program in people with Cervical Cancer, run by Adebola Adegboyega at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer
What is being tested?: Health is Wealth: A Cervical Health Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2023to 20 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky
Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants

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.

Read the 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
Being tested: Health is Wealth: A Cervical Health Program
Keywords: Cervical cancer screening, HPV self-sampling, African American, Sub-Saharan African immigrants
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health is Wealth: A Cervical Health ProgramBehavioural
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.

Study groups in NCT04927494
Study group	Role	What they receive
Black women cervical cancer screening	Experimental	Participants in this group with receive the Health is Wealth intervention. Receives: 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. Receives: 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. Receives: Behavioral: Health is Wealth: A Cervical Health Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants That Completed HPV Self-sampling
HPV self-sampling kit return
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

Secondary outcomes (4)

Change in Perceived Benefits of Pap Test
Perceived benefits of getting a pap test will be assessed with 4 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 4-20. A higher scores indicates greater perceived benefits of getting a pap test.
Measured: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Change in Perceived Susceptibility to Cervical Cancer
Perceived susceptibility will be assessed with 4 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). Score ranges from 4-20. A higher scores indicates greater perceived susceptibility to cervical cancer.
Measured: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Change in Perceived Seriousness to Cervical Cancer
Perceived seriousness will be assessed with 7 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 7-35. A higher score indicates a greater perceived seriousness of cervical cancer.
Measured: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Change in Perceived Cervical Cancer Risk Factors
Perceived cervical cancer risk will be assessed with 11 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 11-55. A higher scores indicates a greater knowledge of cervical cancer risk factors.
Measured: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202320 Jun 2025

First posted16 Jun 2021
Study start1 Jan 2023
Primary completion10 May 2025
Study completion20 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927494
Sponsor's protocol ID: 60704
Other IDs: K01CA251487
Status last verified: May 2026
First submitted: 8 Jun 2021
Last updated: 31 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36447190

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants
ClinicalTrials.gov ID: NCT04927494
Acronym / sponsor ID: 60704
Conditions: Cervical Cancer
Keywords: Cervical cancer screening, HPV self-sampling, African American, Sub-Saharan African immigrants
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: Adebola AdegboyegaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Jan 2023 (actual)
Primary completion: 10 May 2025 (actual)
Study completion: 20 Jun 2025 (actual)
First posted: 16 Jun 2021 (actual)
Results: Posted 1 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Black women cervical cancer screening	Experimental	Behavioral: Health is Wealth: A Cervical Health ProgramParticipants in this group with receive the Health is Wealth intervention.
Phase 1 survey	Other	Behavioral: Health is Wealth: A Cervical Health ProgramCross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
Phase 1 focus group	Other	Behavioral: Health is Wealth: A Cervical Health ProgramQuantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.

Who may qualify

Ages: 30 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health is Wealth: A Cervical Health ProgramHealth 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.	Behavioural	Black women cervical cancer screening, Phase 1 focus group, Phase 1 survey

Primary outcome

Number of Participants That Completed HPV Self-sampling
Time frame: Baseline
HPV self-sampling kit return
Change in Cervical Cancer Knowledge
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
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.
Change in Human Papillomavirus (HPV) Knowledge
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 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. A higher score indicates greater knowledge on HPV.
Change in Self-Efficacy in Completing Pap Test
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
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.
Change in Perceived Barriers to Screening
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
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.

4 secondary outcomes

Change in Perceived Benefits of Pap Test
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Change in Perceived Susceptibility to Cervical Cancer
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Change in Perceived Seriousness to Cervical Cancer
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Change in Perceived Cervical Cancer Risk Factors
Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

Results and safety

Results posted to the registry on 1 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Black Women Cervical Cancer Screening	60	48
Phase 1 Survey	198	132
Phase 1 Focus Group	30	30

Primary outcome: Number of Participants That Completed HPV Self-sampling

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Black Women Cervical Cancer Screening n = 35	Phase 1 Survey n = 0	Phase 1 Focus Group n = 0
Value	25	0	0

Population analysed: Phase 1 survey and Phase 1 focus group participants did not receive self sampling kits. Out of the 60 participants enrolled in baseline only 35 participants opted to self-sample. Out of those 35, 25 completed and returned the self-sample kits.

Primary outcome: Change in Cervical Cancer Knowledge

Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up). Mean (Standard Deviation). Unit: score on a scale

Measure	Black Women Cervical Cancer Screening n = 60	Phase 1 Survey n = 0	Phase 1 Focus Group n = 0
Baseline	4.60 (.19)	–	–
Follow-Up 1 (Post Test)	5.20 (.20)	–	–
Follow-Up 2 (6 Months)	4.17 (.21)	–	–

Population analysed: Phase 1 survey group and Phase 1 focus group were not given the cervical knowledge questionnaire.

Primary outcome: Change in Human Papillomavirus (HPV) Knowledge

Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up). Mean (Standard Deviation). Unit: score on a scale

Measure	Black Women Cervical Cancer Screening n = 60	Phase 1 Survey n = 0	Phase 1 Focus Group n = 0
Baseline	4.21 (0.31)	–	–
Follow-Up 1 (Post Test)	7.51 (0.33)	–	–
Follow Up 2 (6 months)	6.83 (0.35)	–	–

Population analysed: Phase 1 survey group and Phase 1 focus group were not given the HPV knowledge questionnaire.

Primary outcome: Change in Self-Efficacy in Completing Pap Test

Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up). Mean (Standard Deviation). Unit: score on a scale

Measure	Black Women Cervical Cancer Screening n = 60	Phase 1 Survey n = 0	Phase 1 Focus Group n = 0
Baseline	28.51 (0.77)	–	–
Follow-Up 1 (Post Test)	29.62 (0.79)	–	–
Follow-Up 2 (6 Months)	29.03 (0.81)	–	–

Population analysed: Phase 1 survey group and Phase 1 focus group were not given the self-efficacy questionnaire.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Black Women Cervical Cancer Screening	0 of 0	0 of 0
Phase 1 Survey	0 of 0	0 of 0
Phase 1 Focus Group	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36447190Adegboyega 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adebola Adegboyega, PhD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health is Wealth: A Cervical Health Program in people with Cervical Cancer, run by Adebola Adegboyega at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants That Completed HPV Self-sampling (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.