This clinical trial tests the accuracy, feasibility and acceptability of HPV self collection with a community health workshop to improve cervical health screenings for underserved minority women. HPV self-collection is seen as an acceptable and feasible option for cervical cancer screening, especially for underscreened individuals. Underserved groups encounter many barriers, including financial challenges, the lack of health care access and limited knowledge about cancer and the importance of early detection of disease, low health literacy in general and language barriers. Furthermore, traditional screening by Pap smear requires a pelvic examination and cultural beliefs as well as distrust of formalized health care systems may contribute to low screening levels. The combination of self screening HPV testing kits along with a community health education workshop may improve cervical health screenings for underserved minority women.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07336134.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Thomas Jefferson University HospitalStatus: Active
Contact: Sandra D. Dayaratna
Phone: 617-834-3894
PRIMARY OBJECTIVES:
I. To validate the accuracy of Evalyn Brush self-collection kit by comparing their results with clinical Pap smear findings in a cohort of 20 patients, ensuring concordance based on pathology recommendations and Food and Drug Administration (FDA) regulatory standards for new technology assessment. (Phase I)
II. To evaluate the feasibility and acceptability of the Community Health Worker (CHW)4CervicalHealth intervention in promoting human papillomavirus (HPV) self-collection uptake among screening-eligible and under-screened ethnic minority women, assessing key implementation outcome: uptake rates and adherence to follow up if HPV positive. (Phase II)
SECONDARY OBJECTIVES:
I. Changes in participants' HPV-related knowledge, perceived comfort with self-collection and any perceived barriers and facilitators will be secondary outcomes. (Phase II)
OUTLINE: Patients are assigned to 1 of 2 phases. Patients in phase II are assigned to 1 of 2 arms.
PHASE I: Patients receive the Evalyn Brush self collection kit and complete the self swab at their standard of care Pap smear appointment.
PHASE II (ARM 1): Patients attend a community workshop on cervical health, HPV testing, and cervical cancer screening, over 30 minutes, receive the Evalyn Brush self collection kit and instructions and complete the self swab. Patients receive their test results via email or mailed letter. HPV positive patients receive a referral for and assistance in scheduling follow up with the colposcopy clinic.
PHASE II (ARM 2): Patients attend a community workshop on cervical health, HPV testing, and cervical cancer screening, over 30 minutes, receive the Copan Floqswab self collection kit and instructions and complete the self swab. Patients receive their test results via email or mailed letter. HPV positive patients receive a referral for and assistance in scheduling follow up with the colposcopy clinic.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorSandra D. Dayaratna
