Promise Women Project

October 16, 2024 updated by: Mark Dignan, PhD

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: Baseline and Post Intervention (up to 1 week)
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
Time Frame: Baseline and Post Intervention (up to 1 week)
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
Time Frame: Baseline and Post Intervention (up to 1 week)
Test the intervention program's acceptability as evidenced by session attendance
Baseline and Post Intervention (up to 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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