Cervical Cancer, Human Papilloma Virus
Conditions
Keywords
screening, vaccination, Muslim American women, prevention, Health disparities, Acceptability and feasibility., Behavioral intervention, Religious adaptation
Brief summary
The goal of this study is to develop and test an intervention program to improve cervical cancer prevention among Muslim American women. The main questions the investigators aim to answer are: * Will the religiously tailored and culturally appropriate intervention program improve participants' knowledge and acceptance of cervical cancer prevention? * Is the intervention program feasible to conduct and acceptable to participants? Participants will be asked to: * Attend focus group sessions to provide input on the development of educational materials. * Complete pre- and post-intervention surveys to measure changes in knowledge and acceptance of cervical cancer prevention. * Engage in the intervention program, which includes education and experiential practice/communication skills training. * Provide feedback through satisfaction surveys. Researchers will compare participant outcomes before and after the intervention to assess its effectiveness. Additionally, the program's feasibility and acceptability will be evaluated based on enrollment rates, successful implementation, participant engagement, retention, and satisfaction.
Detailed description
This project involves creating special educational materials for Muslim women to learn about cervical cancer prevention. The investigators will engage in discussions with 10 Muslim women during dedicated group sessions to ensure the suitability of the materials. They will also seek input from Muslim religious leaders. Subsequently, they will conduct surveys before and after the program to assess the effectiveness of the materials in facilitating women's learning and comprehension of cervical cancer prevention. To determine its efficacy and acceptability, the investigators will implement the program with an additional 20 women and gather their feedback. The goal of this project is to promote the health and well-being of Muslim women by providing them with culturally and religiously sensitive information regarding cervical cancer prevention.
Interventions
BEHAVIORALPromise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )
The Intervention Arm involves a 90-minute educational session tailored to Muslim women. They will learn about HPV infection risks, cervical cancer risks, and benefits of early screening and HPV vaccination. Discussions cover transmission, consequences, risk factors (behaviors, infections, family history), and importance of early detection. The session provides information on screening methods, check-ups, and HPV vaccine safety. Participants actively engage in discussions, ask questions, and share thoughts. The session empowers women with knowledge to make informed decisions about their health, promoting cervical cancer prevention.
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Mark Dignan, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
In this study, the investigators will conduct a single-arm pilot trial using a pre-and post-test survey design to evaluate the effectiveness of a religiously tailored and culturally appropriate intervention program for promoting cervical cancer prevention among Muslim American women. 20 eligible participants who have not previously participated in our studies will be recruited. Before the intervention, participants will complete a pre-intervention survey to assess their knowledge and acceptance of cervical cancer prevention. Following the intervention, participants will undergo the post-intervention survey to measure any changes in their knowledge and acceptance levels. By utilizing this survey-based approach, the investigators aim to gather valuable data on the impact of the intervention and determine its potential effectiveness in improving participants' understanding and engagement with cervical cancer prevention activities.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria: * Female Muslim individuals above 18 years old. * Able to speak and understand English. * Have not had a hysterectomy. * Have not had a cervical cancer diagnosis. * Willing to participate in the educational program and undergo cervical cancer screening. * Physically well, able to give consent form.
Exclusion criteria
* Under age 18 * Not Muslim * Unable to provide consent * Participated in a pilot study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Who Undergo Cervical Cancer Screening. | Baseline and Post Intervention (up to 1 week) | measured by tracking the number of women who schedule and attend |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Enrolled | Baseline and Post Intervention (up to 1 week) | Test the intervention program's feasibility as evidenced by meeting enrollment targets |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Women That Attend the Education Session | Baseline and Post Intervention (up to 1 week) | Test the intervention program's acceptability as evidenced by session attendance |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Single-arm Trial With a Pre- and Post-test Design The Intervention Arm in the Promise Women Project evaluates a specific educational intervention program for Muslim women to promote cervical cancer prevention. It involves a one-time, 90-minute culturally and religiously tailored educational session with 20 participants. The session covers perceived risks of Human Papilloma Virus (HPV) infection, cervical cancer, and benefits of early screening and vaccination. Pre- and post-intervention surveys measure changes in participants' knowledge. This experimental arm assesses the intervention's effects on knowledge and acceptance of cervical cancer prevention.
Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia ): The Intervention Arm involves a 90-minute educational session tailored to Muslim women. They will learn about HPV infection risks, cervical cancer risks, and benefits of early screening and HPV vaccination. Discussions cover transmission, consequences, risk factors (behaviors, infections, family history), and importance of early detection. The session provides information on screening methods, check-ups, and HPV vaccine safety. Participants actively engage in discussions, ask questions, and share thoughts. The session empowers women with knowledge to make informed decisions about their health, promoting cervical cancer prevention. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | The Single-arm Trial With a Pre- and Post-test Design |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 14.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 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 | 8 Participants |
| Race (NIH/OMB) More than one race | 5 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 | 7 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Women Who Undergo Cervical Cancer Screening.
measured by tracking the number of women who schedule and attend
Time frame: Baseline and Post Intervention (up to 1 week)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Single-arm Trial With a Pre- and Post-test Design | Number of Women Who Undergo Cervical Cancer Screening. | 20 Participants |
Secondary
Number of Women Enrolled
Test the intervention program's feasibility as evidenced by meeting enrollment targets
Time frame: Baseline and Post Intervention (up to 1 week)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Single-arm Trial With a Pre- and Post-test Design | Number of Women Enrolled | 20 Participants |
Other Pre-specified
Number of Women That Attend the Education Session
Test the intervention program's acceptability as evidenced by session attendance
Time frame: Baseline and Post Intervention (up to 1 week)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Single-arm Trial With a Pre- and Post-test Design | Number of Women That Attend the Education Session | 20 Participants |