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