Promise Women Project

Sponsor

Mark Dignan, PhD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05862844

Collaborator

National Cancer Institute (NCI) (NIH), Virginia Commonwealth University (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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 we 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.

Condition or Disease	Intervention/Treatment	Phase
Human Papilloma Virus Cervical Cancer	Behavioral: Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )	N/A

Detailed Description

This project is about making special educational materials for Muslim women to learn how to prevent cervical cancer. The investigators will talk to 10 Muslim women in special group sessions to make sure the materials are right for them. They will also ask Muslim religious leaders for their ideas. Then, they will do surveys before and after the program to see if the materials helped women learn and understand cervical cancer prevention. They will try the program with 20 more women to see if it works well and if they like it. The goal of this project is to help Muslim women stay healthy and prevent cervical cancer by giving them the right information in a way that respects their culture and religion.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

In this study, we 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. We will recruit 20 eligible participants who have not previously participated in our studies. 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, we 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.In this study, we 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. We will recruit 20 eligible participants who have not previously participated in our studies. 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, we 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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

PROMIS WOMAN Education Program : ImProving ceRvical Cancer preventiOn Methods Among Muslim AmerIcans WOMEN

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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. Other Names: Culturally tailored educational session on cervical cancer prevention

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Other Names:

Culturally tailored educational session on cervical cancer prevention

Outcome Measures

Primary Outcome Measures

Number of women who undergo cervical cancer screening. [1 year]
measured by tracking the number of women who schedule and attend

Secondary Outcome Measures

Promise Women Project Feasibility [1 year]
Feasibility will be measured by the number of women enrolled

Other Outcome Measures

Promise Women Project Acceptability [1 year]
Acceptability will be measured by the number of women enrolled that complete the education session and post-session survey
Cervical Cancer Screening Knowledge. [Immediately before and after the educational intervention]
Knowledge will be measured by survey questions regarding cervical cancer screening.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Islamic center of Hampton	Hampton	Virginia	United States	23666
2	the Peninsula Islamic Community Center	Hampton	Virginia	United States	23666
3	Islamic center of Henrico-Alfalah	Henrico	Virginia	United States	23228
4	the Islamic center of Richmond	Richmond	Virginia	United States	23060