This clinical trial studies whether a community based intervention improves cervical cancer screening (CCS) among women in the Hispanic and East African immigrant community. Previous research has shown that CCS remains low among women of the Hispanic and East African immigrant community due to lack of awareness about cervical cancer as well as recommended screening guidelines. The community based intervention in this trial will offer CCS in the Hispanic and East African immigrant community using a test that can be completed by the individual. The test uses a brush that is placed inside the vagina to collect a sample. The self-collected sample is then tested for a virus called human papillomavirus (HPV). Because some types of HPV can cause cervical cancer, checking for HPV, may lower a woman's chance of getting cervical cancer. A community based intervention may be an effective way to improve CCS among women in the Hispanic and East African immigrant community.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07890402.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Jissy Cyriac
PRIMARY OBJECTIVES:
I. Pilot a community based cervical cancer screening intervention using the recently Food and Drug Administration (FDA) approved vaginal HPV self-collection brush.
II. Refine and tailor the proposed intervention based on research participant experience and provider, research coordinator, and community partner feedback.
III. Ensure participants have access to the screening continuum—those who have completed CCS in a community-based setting receive their results and the information/tools to follow-up as needed, especially in the setting of abnormal results.
OUTLINE:
Participants receive written and video self-collection instructions and complete vaginal HPV sample collection using self-collection brush with or without clinician assistance during screening appointment. Participants then receive testing results via phone call and mailed letter. Participants with abnormal test results also receive recommended next steps as well as communication to primary care team on study. Approximately 14-28 days after screening appointment, participants receive a phone call to verify receipt of results and/or outcomes of abnormal testing result follow-up.
After completion of study intervention, participants with abnormal results are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorJissy Cyriac
