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Promise Women Project

Primary Purpose

Human Papilloma Virus, Cervical Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )
Sponsored by
Mark Dignan, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus focused on measuring screening, vaccination, Muslim American women, prevention, Health disparities, Acceptability and feasibility., Behavioral intervention, Religious adaptation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • the Islamic center of Hampton
  • the Peninsula Islamic Community Center
  • Islamic center of Henrico-Alfalah
  • the Islamic center of Richmond

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The single-arm trial with a pre- and post-test design

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of women enrolled
Test the intervention program's feasibility as evidenced by meeting enrollment targets

Full Information

First Posted
May 8, 2023
Last Updated
August 22, 2023
Sponsor
Mark Dignan, PhD
Collaborators
National Cancer Institute (NCI), Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05862844
Brief Title
Promise Women Project
Official Title
PROMIS WOMAN Education Program : ImProving ceRvical Cancer preventiOn Methods Among Muslim AmerIcans WOMEN
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Dignan, PhD
Collaborators
National Cancer Institute (NCI), Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, Cervical Cancer
Keywords
screening, vaccination, Muslim American women, prevention, Health disparities, Acceptability and feasibility., Behavioral intervention, Religious adaptation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The single-arm trial with a pre- and post-test design
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )
Other Intervention Name(s)
Culturally tailored educational session on cervical cancer prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of women who undergo cervical cancer screening.
Description
measured by tracking the number of women who schedule and attend
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of women enrolled
Description
Test the intervention program's feasibility as evidenced by meeting enrollment targets
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Number of women that attend the education session
Description
Test the intervention program's acceptability as evidenced by session attendance
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa Namoos, MD, MPH
Phone
(757) 768-3512
Email
asmaa.namoos@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa L Sheppard, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark B Dignan, PhD, MPH
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
the Islamic center of Hampton
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa M Namoos, MD,MPH
Phone
757-768-3512
Email
asmaa.namoos@vcuhealth.org
Facility Name
the Peninsula Islamic Community Center
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa M Namoos, MD,MPH
Phone
757-768-3512
Email
asmaanamoos88@gmail.com
Facility Name
Islamic center of Henrico-Alfalah
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23228
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Namoos, MD,MPH
Facility Name
the Islamic center of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23060
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa M Namoos
Phone
757-768-3512
Email
asmaa.namoos@vcuhealth.org

12. IPD Sharing Statement

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Promise Women Project

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