Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 32,771
- Locations
- 1
- Primary Endpoint
- Screening Completion by Outreach Approach and Prior Screening Behavior
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 30 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care
Intervention: Usual Care (Other)
Education
Intervention: Education (Behavioral)
Direct Mail
Intervention: Direct Mail (Behavioral)
Opt-in
Intervention: Opt-in (Behavioral)
Outcomes
Primary Outcomes
Screening Completion by Outreach Approach and Prior Screening Behavior
Time Frame: Within 6 months of randomization
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.
Secondary Outcomes
- Screening Initiation by Outreach Approach and Prior Screening Behavior(Within 6 months of randomization)
- Screening Method Choice(Within 6 months of randomization)
- Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior(Within 6 months of randomization)
- Completion of Recommended Follow-up After a Positive Kit Result(Within 6 months of randomization)
- Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior(Within 6 months of randomization)
- Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior(6-12 months following study invitation)
- Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior(3-5 years (projected))