Trial Outcomes & Findings for Cervical Cancer Prevention for Black Adults (NCT NCT04927494)
NCT ID: NCT04927494
Last Updated: 2026-07-31
Results Overview
HPV self-sampling kit return
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
288 participants
Primary outcome timeframe
Baseline
Results posted on
2026-07-31
Participant Flow
Participant milestones
| Measure |
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.
|
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
198
|
30
|
|
Overall Study
COMPLETED
|
48
|
132
|
30
|
|
Overall Study
NOT COMPLETED
|
12
|
66
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
0
|
0
|
|
Overall Study
Eligibility
|
0
|
66
|
0
|
Baseline Characteristics
Cervical Cancer Prevention for Black Adults
Baseline characteristics by cohort
| Measure |
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
Phase 1 Survey
n=132 Participants
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
n=30 Participants
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 6.5 • n=9 Participants
|
43.7 years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
33.67 years
STANDARD_DEVIATION 9.03 • n=267 Participants
|
37.9 years
STANDARD_DEVIATION 9.0 • n=265 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=9 Participants
|
109 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
199 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
23 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=9 Participants
|
132 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
222 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=9 Participants
|
132 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
222 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=9 Participants
|
132 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
222 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
HPV self-sampling kit return
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=35 Participants
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.
|
|---|---|---|---|
|
Number of Participants That Completed HPV Self-sampling
|
0 Participants
|
0 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the cervical knowledge questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Cervical Cancer Knowledge
Baseline
|
—
|
—
|
4.60 score on a scale
Standard Deviation .19
|
|
Change in Cervical Cancer Knowledge
Follow-Up 1 (Post Test)
|
—
|
—
|
5.20 score on a scale
Standard Deviation .20
|
|
Change in Cervical Cancer Knowledge
Follow-Up 2 (6 Months)
|
—
|
—
|
4.17 score on a scale
Standard Deviation .21
|
PRIMARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the HPV knowledge questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Human Papillomavirus (HPV) Knowledge
Follow-Up 1 (Post Test)
|
—
|
—
|
7.51 score on a scale
Standard Deviation 0.33
|
|
Change in Human Papillomavirus (HPV) Knowledge
Follow Up 2 (6 months)
|
—
|
—
|
6.83 score on a scale
Standard Deviation 0.35
|
|
Change in Human Papillomavirus (HPV) Knowledge
Baseline
|
—
|
—
|
4.21 score on a scale
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the self-efficacy questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Self-Efficacy in Completing Pap Test
Baseline
|
—
|
—
|
28.51 score on a scale
Standard Deviation 0.77
|
|
Change in Self-Efficacy in Completing Pap Test
Follow-Up 1 (Post Test)
|
—
|
—
|
29.62 score on a scale
Standard Deviation 0.79
|
|
Change in Self-Efficacy in Completing Pap Test
Follow-Up 2 (6 Months)
|
—
|
—
|
29.03 score on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the barriers questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Perceived Barriers to Screening
Baseline
|
—
|
—
|
33.23 score on a scale
Standard Deviation 0.93
|
|
Change in Perceived Barriers to Screening
Follow Up 1 (post test)
|
—
|
—
|
33.91 score on a scale
Standard Deviation 0.98
|
|
Change in Perceived Barriers to Screening
Follow Up 2 (6 months)
|
—
|
—
|
32.66 score on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the benefits questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Perceived Benefits of Pap Test
Follow Up 2 (6 months)
|
—
|
—
|
11.85 score on a scale
Standard Deviation 0.38
|
|
Change in Perceived Benefits of Pap Test
Baseline
|
—
|
—
|
12.16 score on a scale
Standard Deviation 0.35
|
|
Change in Perceived Benefits of Pap Test
Follow Up 1 (post test)
|
—
|
—
|
12.17 score on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the susceptibility questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Perceived Susceptibility to Cervical Cancer
Baseline
|
—
|
—
|
6.52 score on a scale
Standard Deviation 0.32
|
|
Change in Perceived Susceptibility to Cervical Cancer
Follow Up 1 (post-test)
|
—
|
—
|
7.85 score on a scale
Standard Deviation 0.34
|
|
Change in Perceived Susceptibility to Cervical Cancer
Follow Up 2 (6 months)
|
—
|
—
|
7.13 score on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the seriousness questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Perceived Seriousness to Cervical Cancer
Follow Up 2 (6 months)
|
—
|
—
|
18.89 score on a scale
Standard Deviation 0.50
|
|
Change in Perceived Seriousness to Cervical Cancer
Baseline
|
—
|
—
|
19.75 score on a scale
Standard Deviation 0.45
|
|
Change in Perceived Seriousness to Cervical Cancer
Follow Up 1 (post-test)
|
—
|
—
|
19.90 score on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)Population: Phase 1 survey group and Phase 1 focus group were not given the questionnaire.
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.
Outcome measures
| Measure |
Phase 1 Survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
|
Phase 1 Focus Group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
|
Black Women Cervical Cancer Screening
n=60 Participants
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.
|
|---|---|---|---|
|
Change in Perceived Cervical Cancer Risk Factors
Baseline
|
—
|
—
|
33.89 score on a scale
Standard Deviation 0.93
|
|
Change in Perceived Cervical Cancer Risk Factors
Follow Up 1 (post-test)
|
—
|
—
|
39.18 score on a scale
Standard Deviation 0.98
|
|
Change in Perceived Cervical Cancer Risk Factors
Follow Up 2 (6 months)
|
—
|
—
|
35.65 score on a scale
Standard Deviation 1.01
|
Adverse Events
Black Women Cervical Cancer Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Survey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Focus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place