This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04411849.
PRIMARY OBJECTIVES:
I. Determine the effectiveness of the intervention in increasing cervical cancer screening (primary outcome).
II. Assess the fidelity, sustainability, and cost-effectiveness of the intervention (implementation outcome).
III. Determine satisfaction with the intervention at the patient- and provider-levels (client outcome).
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: During year 1, participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an informational sheet about cervical cancer. Participants who do not return their self-test within 2 weeks receive telephone-based patient navigation. During years 2-5, participants complete a satisfaction survey and have their medical record reviewed. During years 3-5, participants who remain unscreened/underscreened may again receive the HPV self-testing intervention.
GROUP II: During year 1, participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and an informational sheet about cervical cancer. During years 2-5, participants complete a satisfaction survey and have their medical record reviewed. During year 3, participants receive the HPV self-testing intervention and patient navigation as in Group I. During years 4-5, participants who remain unscreened/underscreened may again receive the HPV self-testing intervention.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorPaul Reiter
