Promise Women Project

NCT05862844 | Completed Results

• 2 other identifiers: HM20024502_VCU3P30CA177558-10S1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Human Papilloma Virus; Cervical Cancer

Keywords

screening; vaccination; Muslim American women; prevention; Health disparities; Acceptability and feasibility.; Behavioral intervention; Religious adaptation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Women Enrolled

  Baseline and Post Intervention (up to 1 week)

Other Outcomes (1)

• Number of Women That Attend the Education Session

  Baseline and Post Intervention (up to 1 week)

Study Arms (1)

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

EXPERIMENTAL

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 )

Interventions

Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia ) BEHAVIORAL

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.

Also known as: Culturally tailored educational session on cervical cancer prevention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Under age 18
• Not Muslim
• Unable to provide consent
• Participated in a pilot study

Sponsors & Collaborators

• Mark Dignan, PhD: lead
• National Cancer Institute (NCI): collaborator
• Virginia Commonwealth University: collaborator

Study Sites (4)

the Islamic center of Hampton

Hampton, Virginia, 23666, United States

Location

the Peninsula Islamic Community Center

Hampton, Virginia, 23666, United States

Location

Islamic center of Henrico-Alfalah

Henrico, Virginia, 23228, United States

Location

the Islamic center of Richmond

Richmond, Virginia, 23060, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Asmaa Namoos
• Organization: School of Medicine, Virginia Commonwealth University

Asmaa.Namoos@vcuhealth.org

804-628-4754

Study Officials

• Vanessa L Sheppard, PhD

  Virginia Commonwealth University

  STUDY DIRECTOR

• Mark B Dignan, PhD, MPH

  University of Kentucky

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: September 25, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-10

Locations

US (4)