CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32,771 enrolled
Drug / intervention
Usual Care +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04679675
NCT04679675N/ACompleted
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Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial

Kaiser Permanente·interventional·Posted Dec 22, 2020·Updated Sep 18, 2023

In Brief

A clinical study evaluating Usual Care, Education, and 2 other interventions for Uterine Cervical Neoplasm and 13 related conditions. Completed, enrolled 32,771 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), University of Washington, University of Texas Southwestern Medical Center

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 22, 2020
Enrollment StartNov 20, 2020
Primary CompletionJul 29, 2022
Study CompletionJul 29, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.5 years ago

Interventions

Usual Careother

Subjects will receive Kaiser Permanente Washington standard of 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.

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.

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.