Promise Women Project

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Human Papilloma Virus
• Intervention / Treatment: Behavioral: Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Hampton, Virginia, United States, 23666
      • the Islamic center of Hampton
    • Hampton, Virginia, United States, 23666
      • the Peninsula Islamic Community Center
    • Henrico, Virginia, United States, 23228
      • Islamic center of Henrico-Alfalah
    • Richmond, Virginia, United States, 23060
      • the Islamic center of Richmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women Who Undergo Cervical Cancer Screening.	measured by tracking the number of women who schedule and attend	Baseline and Post Intervention (up to 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women Enrolled	Test the intervention program's feasibility as evidenced by meeting enrollment targets	Baseline and Post Intervention (up to 1 week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women That Attend the Education Session	Test the intervention program's acceptability as evidenced by session attendance	Baseline and Post Intervention (up to 1 week)

Collaborators and Investigators

• Sponsor: Mark Dignan, PhD
• Collaborators: National Cancer Institute (NCI); Virginia Commonwealth University
• Investigators: Study Director: Vanessa L Sheppard, PhD, Virginia Commonwealth University; Study Director: Mark B Dignan, PhD, MPH, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: prevention; screening; vaccination; Behavioral intervention; Health disparities; Muslim American women; Acceptability and feasibility.; Religious adaptation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Neoplasms, Squamous Cell; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Papilloma
• Other Study ID Numbers: HM20024502_VCU; 3P30CA177558-10S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No