Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial

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.

Conditions

• Uterine Cervical Neoplasm
• Uterine Neoplasms
• Genital Neoplasms, Female
• Urogenital Neoplasms
• Neoplasms by Site
• Neoplasms
• Uterine Cervical Diseases
• Uterine Diseases
• Cervical Cancer
• Cervical Dysplasia
• Human Papilloma Virus
• HPV-Related Cervical Carcinoma
• HPV Infection
• HPV-Related Malignancy

Interventions

OTHER

Usual Care

Subjects will receive Kaiser Permanente Washington standard of care.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Washington

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Beverly B Green, MD, MPH · Kaiser Permanente

• Rachel L Winer, PhD, MPH · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

64 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-20

Primary Completion

2022-07-29

Completion

2023-07-29

Countries

• United States

Study Locations