NCT04679675

Brief Summary

The Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based HPV kits for improving cervical cancer screening uptake and its cost-effectiveness. The investigators will compare cervical cancer screening uptake within six months among women randomized to different outreach approaches based on prior screening behavior: A) Adherent and coming due: direct mail HPV kit vs. opt-in HPV kit vs. education; B) Overdue: direct mail HPV kit vs. education; C) Unknown: opt-in HPV kit vs. education.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32,771

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2023

Completed
26 days until next milestone

Results Posted

Study results publicly available

August 24, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

December 9, 2020

Results QC Date

July 19, 2023

Last Update Submit

September 6, 2023

Conditions

Uterine Cervical NeoplasmUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesCervical CancerCervical DysplasiaHuman Papilloma VirusHPV-Related Cervical CarcinomaHPV InfectionHPV-Related Malignancy

Keywords

Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • Screening Completion by Outreach Approach and Prior Screening Behavior

    Rate of completing cervical cancer screening completion by outreach approach and prior screening behavior. Screening completion defined by returning the home kit and attending the recommended in clinic follow-up (if applicable); or receiving in clinic screening.

    Within 6 months of randomization

Secondary Outcomes (7)

  • Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior

    Within 6 months of randomization

  • Screening Initiation by Outreach Approach and Prior Screening Behavior

    Within 6 months of randomization

  • Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior

    Within 6 months of randomization

  • Completion of Recommended Follow-up After a Positive Kit Result

    Within 6 months of randomization

  • Screening Method Choice

    Within 6 months of randomization

  • +2 more secondary outcomes

Study Arms (4)

Usual Care

ACTIVE COMPARATOR
Other: Usual Care

Education

ACTIVE COMPARATOR
Behavioral: Education

Direct Mail

ACTIVE COMPARATOR
Behavioral: Direct Mail

Opt-in

ACTIVE COMPARATOR
Behavioral: Opt-in

Interventions

Usual CareOTHER

Subjects will receive Kaiser Permanente Washington standard of care.

Usual Care
EducationBEHAVIORAL

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.

Education
Direct MailBEHAVIORAL

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.

Direct Mail
Opt-inBEHAVIORAL

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.

Opt-in

Eligibility Criteria

Age30 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Currently enrolled at Kaiser Permanente Washington
  • Female sex
  • years to 64 years of age
  • An intact cervix
  • Has a primary care provider at Kaiser Permanente Washington

You may not qualify if:

  • Anyone flagged by the delivery system as being on a non-routine screening schedule
  • On "do not contact list" for research studies
  • Currently pregnant or had a pregnancy-related procedure within prior 3 months
  • Language interpreter needed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • 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. 2026 Jan;142:109374. doi: 10.1016/j.pec.2025.109374. Epub 2025 Oct 3.

    PMID: 41067140DERIVED

  • 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.

    PMID: 38015219DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesUterine Cervical DysplasiaPapillomavirus Infections

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMale Urogenital DiseasesPrecancerous ConditionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Dr. Beverly Green
Organization
Kaiser Permanente Washington Health Research Institute
bev.b.green@kp.org
206-220-2997

Study Officials

  • Beverly B Green, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

  • Rachel L Winer, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The investigators will test interventions separately by prior cervical cancer screening behavior: Screening Adherent, Overdue, and Unknown history. Interventions will differ by screening behavior. 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 22, 2020

Study Start

November 20, 2020

Primary Completion

July 29, 2022

Study Completion

July 29, 2023

Last Updated

September 18, 2023

Results First Posted

August 24, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Resources developed during the study will be made available in accordance with the NIH Data Sharing Policy to researchers in both the private and public sector free or for a nominal charge and with minimal restriction. Deidentified data will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes. Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants or to disclose Kaiser Permanente proprietary information; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by Kaiser Permanente's Human Subjects Review Committee.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)