Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women

Research project

Description

The proposed study will investigate whether cervical cancer screening coverage among under-screened women could be improved through the use of at-home human papillomavirus (HPV) self-collection kits delivered by mail. Invasive cervical cancer (ICC) is highly preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals or at all. Insufficient screening is the largest risk factor for ICC .More than half of ICC cases occur in these under-screened women. Infection with high-risk (oncogenic) HPV is the primary cause of ICC; the USPSTF recommends physician-collected HPV testing with Pap smears (co-testing) for women 30 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection and has comparable sensitivity and specificity for the detection of high-grade cervical lesions as physician-collection.
This 2-arm randomized control trial of 870 women will investigate whether offering HPV testing by at-home self-collection to women overdue for cervical cancer screening by mail will increase their likelihood of completing screening. Those randomized to the intervention arm will be mailed kits to self-collect cervico-vaginal samples and return the samples by mail. The self-collected samples will be tested for oncogenic HPV and results reported by phone to participants. HPV self-test negative women will be considered screening complete. All women in the trial will receive education on cervical cancer, and an opportunity to receive assistance to schedule a needed appointment for free screening at a study-affiliated community clinic. Screening completion will be defined as in-clinic co-testing or receipt of negative HPV self-collection results.
StatusActive
Effective start/end date4/9/153/31/20

Funding

  • NIH National Cancer Institute (NCI)

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Early Detection of Cancer
Uterine Cervical Neoplasms
Postal Service
Appointments and Schedules
Physicians
Papanicolaou Test
Papillomavirus Infections
Education
Sensitivity and Specificity
Infection