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| ID | Type | Description | Link |
|---|---|---|---|
| K01CA251487 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black women cervical cancer screening | Experimental | Participants in this group with receive the Health is Wealth intervention. |
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| Phase 1 survey | Other | Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening. |
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| Phase 1 focus group | Other | Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Anatomically female with a cervix.
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| Name | Affiliation | Role |
|---|---|---|
| Adebola Adegboyega, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36447190 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Black Women Cervical Cancer Screening | Participants in this group with receive the Health is Wealth intervention. 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. |
| FG001 | Phase 1 Survey | Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening. |
| FG002 | Phase 1 Focus Group | Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Black Women Cervical Cancer Screening | Participants in this group with receive the Health is Wealth intervention. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Completed HPV Self-sampling | HPV self-sampling kit return | 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. | Posted | Count of Participants | Participants | Baseline |
|
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Death, serious adverse events and other (non-serious adverse events) were not assessed for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Black Women Cervical Cancer Screening | Participants in this group with receive the Health is Wealth intervention. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adebola Adegboyega | University of Kentucky | 859-323-5196 | aoadeg2@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2025 | May 5, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2024 | Jun 24, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 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) |
| 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. | 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. | 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. | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
| BG001 | Phase 1 Survey | Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening. |
| BG002 | Phase 1 Focus Group | Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Phase 1 Survey | Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening. |
| OG002 | Phase 1 Focus Group | Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. |
|
|
| Primary | 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. | Phase 1 survey group and Phase 1 focus group were not given the cervical knowledge questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| Primary | 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. | Phase 1 survey group and Phase 1 focus group were not given the HPV knowledge questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| Primary | 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. | Phase 1 survey group and Phase 1 focus group were not given the self-efficacy questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| Primary | 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. | Phase 1 survey group and Phase 1 focus group were not given the barriers questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
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| Secondary | 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. | Phase 1 survey group and Phase 1 focus group were not given the benefits questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| Secondary | 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. | Phase 1 survey group and Phase 1 focus group were not given the susceptibility questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| Secondary | 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. | Phase 1 survey group and Phase 1 focus group were not given the seriousness questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| Secondary | 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. | Phase 1 survey group and Phase 1 focus group were not given the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Phase 1 Survey | Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Phase 1 Focus Group | Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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