Cervical Cancer
Conditions
Keywords
Cervical cancer screening, HPV self-sampling, African American, Sub-Saharan African immigrants
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.
Interventions
BEHAVIORALHealth 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.
Sponsors
Adebola Adegboyega
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Completed HPV Self-sampling | Baseline | HPV self-sampling kit return |
| Change in Cervical Cancer Knowledge | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Benefits of Pap Test | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) | 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. |
| Change in Perceived Susceptibility to Cervical Cancer | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) | 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. |
| Change in Perceived Seriousness to Cervical Cancer | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) | 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. |
| Change in Perceived Cervical Cancer Risk Factors | 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdebola Adegboyega, PhD
University of Kentucky
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.7 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 222 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed