Clinical trial NCT05862844: Promise Women Project
Official title: PROMIS WOMAN Education Program : ImProving ceRvical Cancer preventiOn Methods Among Muslim AmerIcans WOMEN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Cervical Cancer
Keywords: screening
vaccination
Muslim American women
prevention
Health disparities
Acceptability and feasibility.
Behavioral intervention
Religious adaptation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Virginia Commonwealth University
First posted: 2023-05-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Women Who Undergo Cervical Cancer Screening.
timeFrame: Baseline and Post Intervention (up to 1 week)
Secondary outcomes:
measure: Number of Women Enrolled
timeFrame: Baseline and Post Intervention (up to 1 week)
Other outcomes:
measure: Number of Women That Attend the Education Session
timeFrame: Baseline and Post Intervention (up to 1 week)
Locations:
city: Hampton
country: United States
facility: the Islamic center of Hampton
state: Virginia
city: Hampton
country: United States
facility: the Peninsula Islamic Community Center
state: Virginia
city: Henrico
country: United States
facility: Islamic center of Henrico-Alfalah
state: Virginia
city: Richmond
country: United States
facility: the Islamic center of Richmond
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Vanessa L Sheppard, PhD
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Mark B Dignan, PhD, MPH
role: STUDY_DIRECTOR
References: