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

Cervical Cancer Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679675
• Other study ID #: 00002344
• Secondary ID: R01CA240375
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: July 29, 2023

Study information

• Verified date: September 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32771
• Est. completion date: July 29, 2023
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Anyone flagged by the delivery system as being on a non-routine screening schedule
• 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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	National Cancer Institute (NCI), University of Texas Southwestern Medical Center, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior	Incremental cost-effectiveness ratio, which will be defined for each outreach approach within each screening behavior subgroup. Also, comparisons across screening behavior subgroups of usual care plus education to usual care.	Within 6 months of randomization
Secondary	Screening Initiation by Outreach Approach and Prior Screening Behavior	Screening Initiation defined as returning the home kit or receiving in clinic cervical cancer screening.	Within 6 months of randomization
Secondary	Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior	Time from randomization to 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	Completion of Recommended Follow-up After a Positive Kit Result	Proportion of intervention group women who complete recommended follow-up after a positive kit result by outreach approach and prior screening behavior. Per current guidelines, in-clinic Pap after other-HR HPV positive; or colposcopy after HPV 16/18+ HPV self-collection	Within 6 months of randomization
Secondary	Screening Method Choice	Proportion of intervention group women who do not screen, return the home kit or receive in-clinic screening by outreach approach and prior screening behavior. Screening uptake outcome (no screen, home kit, or in-clinic) by outreach approach and by prior screening behavior	Within 6 months of randomization
Secondary	Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior	Through focus groups, the investigators will explore patient preference for, and satisfaction with, home HPV screening and barriers to follow-up of abnormal screening results.	6-12 months following study invitation
Secondary	Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior	Economic assessment of system-level financial consequences of adopting home-based HPV screening for cervical cancer. These analyses will evaluate the needed time to follow-up for the next cervical cancer screening to reduce gaps in cervical cancer screening HEDIS metrics, which also addresses program affordability.	3-5 years (projected)