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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04679675
Other study ID # 00002344
Secondary ID R01CA240375
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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