Human Papilloma VirusNCT05862844
Promise Women Project
A study testing Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia ) in people with Human Papilloma Virus and Cervical Cancer, run by Mark Dignan, PhD at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Cervical Cancer
- What is being tested?
- Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Under age 18
- Not Muslim
- Unable to provide consent
- Participated in a pilot study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
the Islamic center of Hampton
Hampton, Virginia, 23666
the Peninsula Islamic Community Center
Hampton, Virginia, 23666
Islamic center of Henrico-Alfalah
Henrico, Virginia, 23228
the Islamic center of Richmond
Richmond, Virginia, 23060
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Human Papilloma Virus, Cervical Cancer
- Being tested
- Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )
- Keywords
- screening, vaccination, Muslim American women, prevention, Health disparities, Acceptability and feasibility., Behavioral intervention, Religious adaptation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )Behavioural
Also called Culturally tailored educational session on cervical cancer prevention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women Who Undergo Cervical Cancer Screening.
measured by tracking the number of women who schedule and attend
Measured: Baseline and Post Intervention (up to 1 week)
Secondary outcomes (1)
Number of Women Enrolled
Test the intervention program's feasibility as evidenced by meeting enrollment targets
Measured: Baseline and Post Intervention (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start25 Sep 2023
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Dignan, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Virginia Commonwealth University
- Responsible party
- Sponsor-investigator, Mark Dignan, PhD, University of Kentucky
- Investigators
- Vanessa L Sheppard, PhD, Study director, Virginia Commonwealth UniversityMark B Dignan, PhD, MPH, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862844
- Sponsor's protocol ID
- HM20024502_VCU
- Other IDs
- 3P30CA177558-10S1
- Status last verified
- Oct 2024
- First submitted
- 8 May 2023
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMIS WOMAN Education Program : ImProving ceRvical Cancer preventiOn Methods Among Muslim AmerIcans WOMEN
- ClinicalTrials.gov ID
- NCT05862844
- Acronym / sponsor ID
- HM20024502_VCU
- Conditions
- Human Papilloma Virus, Cervical Cancer
- Keywords
- screening, vaccination, Muslim American women, prevention, Health disparities, Acceptability and feasibility., Behavioral intervention, Religious adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mark Dignan, PhDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Virginia Commonwealth University
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| The single-arm trial with a pre- and post-test design | Experimental | Behavioral: Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Under age 18
- Not Muslim
- Unable to provide consent
- Participated in a pilot study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )Also: Culturally tailored educational session on cervical cancer preventionThe 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. | Behavioural | The single-arm trial with a pre- and post-test design |
Primary outcome
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
1 secondary outcome
Number of Women Enrolled
Time frame: Baseline and Post Intervention (up to 1 week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Human Papilloma Virus
Active, not recruiting
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Human Papilloma Virus (HPV) Vaccine
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa L Sheppard, PhD study director
Virginia Commonwealth University
Mark B Dignan, PhD, MPH study director
University of Kentucky
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia ) in people with Human Papilloma Virus and Cervical Cancer, run by Mark Dignan, PhD at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Women Who Undergo Cervical Cancer Screening. (time frame: Baseline and Post Intervention (up to 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.