This clinical trial tests how well a patient navigation for the prevention of cervical cancer intervention (PINPOINT) works to improve cervical cancer screening among women living with chronic conditions. Each year in the United States, 4,000 women unnecessarily die of cervical cancer. Cervical cancer is preventable via screening. Screening includes testing for human papillomavirus (HPV), the leading risk factor for cervical cancer, or a cervical cytology test (pap smear) that allows for examining the cervix for abnormalities or precancerous cells. To achieve the goal of eliminating cervical cancer in the United States by 2050, it is imperative to address barriers to cervical cancer screening through the implementation of evidence-based strategies that have been shown to improve screening. Cervical cancer screening self-collection tests allow women to collect their own samples to be tested and have been shown to yield results comparable to clinician collected samples completed in the clinic, increase screening rates, and are preferred among under-screened women.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07351110.
Locations matching your search criteria
United States
Florida
Gainesville
UF Health Cancer Institute - GainesvilleStatus: Active
Contact: Rahma S. Mkuu
Phone: 352-294-8419
PRIMARY OBJECTIVE:
I. Pilot test the PINPOINT intervention and assess the appropriateness, feasibility, and acceptability of the PINPOINT intervention.
SECONDARY OBJECTIVE:
I. Characterize the health and sociodemographic characteristics and reasons for non-participation for patients who do not choose to participate in the pilot study and do not complete the intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a brief educational session, an option to either conduct HPV self-collection or provider administered cervical cancer screening (pap smear, HPV test, or both) and receive follow-up reminder text message and telephone call or email for up to 6 months on study.
ARM II: Patients receive standard of care reminders for in-person cervical cancer screening (pap smear, HPV test, or both) on study.
After completion of study intervention, patients are followed up to 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorRahma S. Mkuu