This clinical trial compares the impact of high-risk human papillomavirus (hrHPV) self-sampling in the emergency department (ED) to a historical control cohort that received a referral for clinic-based testing on cervical cancer (CC) screening. CC is among the most preventable forms of cancer and screening is recommended for all persons with a cervix that are 21-65 years old, however, less than 75% of these women in the United States are up to date with screening. In addition, the very lowest rates of CC screening are among people using the ED as their usual source of care. HrHPV testing is an effective method to detect precancerous cervical tissue and testing every 5 years is recommended as an effective CC screening method. Unlike clinic-based testing, hrHPV testing offers the possibility of self-sampling. Self-sampling does not require a pelvic examination and the specimen is collected by the individual. Self-sampling for hrHPV in the ED may be an effective method compared to a referral for clinic-based testing to increase CC screening.
Additional locations may be listed on ClinicalTrials.gov for NCT06796738.
Locations matching your search criteria
United States
New York
Rochester
University of RochesterStatus: Active
Contact: David H. Adler
Phone: 585-275-1233
PRIMARY OBJECTIVES:
I. Compare uptake of CC screening through use of an hrHPV self-sampling kit for in-ED use to CC screening uptake among individuals in an historical control cohort (National Cancer Institute [NCI] return on investiment [ROI] project with enrollment from 2020-2023; N=544) who only received a recommendation for clinic-based screening.
II. Evaluate the impact of hrHPV self-sampling on the completion of subsequent clinic-based CC screening.
III. Examine participant acceptability and operational feasibility of the intervention.
OUTLINE:
Patients receive self-sampling instruction and undergo hrHPV swab self-sample collection during emergency department visit. Patients and their primary care provider receive HPV test results with recommendations for the timing of their next screening and, if necessary, any additional screening or testing. After follow-up, patients who have not completed the CC screening process or who are lost to follow-up receive a call to arrange completion of follow-up testing.
After completion of study intervention, patients are followed up at 150 days.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Rochester
Principal InvestigatorDavid H. Adler
