This clinical trial aims to compare the efficacy and patient experience of telehealth based self-collected cervical cancer screening to mail based. Giving human papillomavirus (HPV) self-collection instructions via telehealth may increase self screening efforts to help diagnose and treat patients with cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05089825.
PRIMARY OBJECTIVE:
I. Compare the efficacy and patient experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan.
SECONDARY OBJECTIVE:
I. Patient perceived experience with self-collection, patient physical discomfort with self-collection, comparing role of telehealth in pre- and post- menopausal women’s comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visit, evaluating women’s experiences with receiving results through a patient portal, exploring clinical and demographic predictors for self-collection experience.
OUTLINE: Participants are randomized to 1 of 2 arms.
Arm 1: Participants receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Act (CLIA) certified collection kit.
Arm 2: Participants receive collection kit as in Arm 1 and complete a telehealth-based instructional visit.
After completion of study, participants are followed up at 1-2 weeks.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationOHSU Knight Cancer Institute
Principal InvestigatorAmanda S Bruegl