Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
NCT ID: NCT04679675
Last Updated: 2023-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
32771 participants
INTERVENTIONAL
2020-11-20
2023-07-29
Brief Summary
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Detailed Description
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In August 2018, the US Preventive Services Task Force released updated cervical cancer screening guidelines that include human papillomavirus (HPV) testing alone (ie, primary HPV screening) as a newly recommended strategy for women aged 30-65 years. With primary HPV screening, home-based screening is an emerging option, because HPV tests (unlike Pap tests) can be performed on clinician- or self-collected samples. Self-collected samples are as sensitive as clinician-collected samples in detecting HPV and mailing HPV self-sampling kits increases screening participation. As US healthcare systems prepare to implement primary HPV screening, they will need to consider a variety of strategies. To date, HPV self-sampling randomized clinical trials have included only overdue women; no study has evaluated uptake and acceptance of HPV self-sampling kits as an alternative to in-clinic screening in a screening-adherent population.
Based on our Home-based Options to Make cervical cancer screening Easy (HOME) trial (ClinicalTrials.gov, NCT02005510), most women will test negative (88%) and can continue routine screening; 11% will require in-clinic follow-up: 3% directly to colposcopy (HPV-16/18+ results) and 8% to Pap because of "HPV+ other" results or an unsatisfactory result (\<1%). For home-based HPV screening strategies to be successful, ensuring high follow-up compliance in the minority of women who test positive is critical.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Previously Adherent: Previously screened for cervical cancer with a known due date within three months
Overdue: Never screened for cervical cancer; or HPV and Pap co-test \>5.25 years ago \[or Pap alone \>3.25 years ago\]; or no past Pap and continuously enrolled at Kaiser Permanente Washington for ≥3.25 years.
Unknown Prior Screening Behavior: Enrolled at Kaiser Permanente Washington for ≥6 months and \<3.25 years, with no recorded cervical cancer screening history.
Cohort randomization allocation will be assigned as follows to intervention arms: Previously Adherent (Usual Care, Education, Opt-in, and Direct Mail); Overdue (Usual Care, Education, and Direct Mail); and Unknown (Usual Care, Education, and Opt-in).
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Usual Care
Usual Care
Subjects will receive Kaiser Permanente Washington standard of care.
Education
Education
Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
Direct Mail
Direct Mail
Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
Opt-in
Opt-in
Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
Interventions
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Usual Care
Subjects will receive Kaiser Permanente Washington standard of care.
Education
Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
Direct Mail
Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
Opt-in
Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
Eligibility Criteria
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Inclusion Criteria
* Female sex
* 30 years to 64 years of age
* An intact cervix
* Has a primary care provider at Kaiser Permanente Washington
Exclusion Criteria
* Previously randomized to the intervention arm of the HOME trial or invited to the PATH study (Participants from the PATH study and individuals randomized to the intervention arm in the HOME Study are excluded from STEP because their prior inclusion in a STEP-related research study could influence their screening uptake and affect the outcome of this trial.)
* On "do not contact list" for research studies
* Currently pregnant or had a pregnancy-related procedure within prior 3 months
* Language interpreter needed
30 Years
64 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
University of Texas Southwestern Medical Center
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Beverly B Green, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Rachel L Winer, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Countries
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References
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Tiro JA, Metcalfe S, Muthukrishnan M, Jose A, Hansen K, Lin J, Dorsey CN, Gao H, Lacey C, Anderson ML, Meenan RT, Green BB, Buist DSM, Sparks A, Winer RL. Promoting cervical cancer screening via a mailed HPV self-collection kit: Reactions from screeners and non-screeners. Patient Educ Couns. 2025 Oct 3;142:109374. doi: 10.1016/j.pec.2025.109374. Online ahead of print.
Winer RL, Lin J, Anderson ML, Tiro JA, Green BB, Gao H, Meenan RT, Hansen K, Sparks A, Buist DSM. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1971-1981. doi: 10.1001/jama.2023.21471.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00002344
Identifier Type: -
Identifier Source: org_study_id
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