Cervical Cancer Clinical Trial
— STEPOfficial title:
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial
Verified date | September 2023 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Washington Health Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Cancer Institute (NCI), University of Texas Southwestern Medical Center, University of Washington |
United States,
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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