N/A
N=32,771
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Uterine Cervical Neoplasm · Uterine Neoplasms · Genital Neoplasms, Female · Urogenital Neoplasms · Neoplasms by Site
Bottom Line
View on ClinicalTrials.gov: NCT04679675 ↗Enrolled (actual)
32,771
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Screening Completion by Outreach Approach and Prior Screening Behavior — 3671; 3960; 1482; 3956 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care (Other); Education (Behavioral); Direct Mail (Behavioral); Opt-in (Behavioral)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Screening Completion by Outreach Approach and Prior Screening Behavior |
3671; 3960; 1482; 3956; 5488; 1408 | 0.05 |
| SECONDARY Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior |
— | — |
| SECONDARY Screening Initiation by Outreach Approach and Prior Screening Behavior |
— | — |
| SECONDARY Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior |
— | — |
| SECONDARY Completion of Recommended Follow-up After a Positive Kit Result |
— | — |
| SECONDARY Screening Method Choice |
— | — |
| SECONDARY Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior |
— | — |
| SECONDARY Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04679675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.