Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Condition: Uterine Cervical Neoplasm; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Cervical Cancer; Cervical Dysplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma; HPV Infection; HPV-Related Malignancy
MeSH terms: Papillomavirus Infections; Neoplasms; Uterine Cervical Neoplasms; Papilloma; Uterine Cervical Dysplasia; Neoplasms by Site; Urogenital Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Uterine Cervical Diseases
Study type: Interventional

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.
    

Intervention name(s): Usual Care; Education; Direct Mail; Opt-in
Intervention type(s): Other; Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will receive Kaiser Permanente Washington standard of care.; 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 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will test interventions separately by prior cervical cancer screening behavior: Screening Adherent, Overdue, and Unknown history. Interventions will differ by screening behavior.
Previously Adherent: Previously screened for cervical cancer with a known due date within three months
Overdue: Never screened for cervical cancer; or HPV and Pap co-test >5.25 years ago [or Pap alone >3.25 years ago]; or no past Pap and continuously enrolled at Kaiser Permanente Washington for ≥3.25 years.
Unknown Prior Screening Behavior: Enrolled at Kaiser Permanente Washington for ≥6 months and <3.25 years, with no recorded cervical cancer screening history.
Cohort randomization allocation will be assigned as follows to intervention arms: Previously Adherent (Usual Care, Education, Opt-in, and Direct Mail); Overdue (Usual Care, Education, and Direct Mail); and Unknown (Usual Care, Education, and Opt-in).
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Cancer Screening