NCT04679675

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32,771 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 30 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The scientific objective of the proposed research is to study whether an in-home programmatic HPV screening outreach strategy improves cervical cancer screening initiation and uptake. Identifying new, patient-centered options that motivate continued screening initiation and uptake is essential now and in the future. 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

• 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

Type	Name	Description
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.

Timeline

• Start date: 2020-11-20
• Primary completion: 2022-07-29
• Completion: 2023-07-29
• First posted: 2020-12-22
• Last updated: 2023-09-18
• Results posted: 2023-08-24

Locations

1 site across 1 country: United States