Clinical trial NCT04679675: Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Official title: Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Cancer Screening
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Washington
name: University of Texas Southwestern Medical Center
First posted: 2020-12-22
Enrollment: 32771
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Screening Completion by Outreach Approach and Prior Screening Behavior
timeFrame: Within 6 months of randomization
Secondary outcomes:
measure: Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior
timeFrame: Within 6 months of randomization
measure: Screening Initiation by Outreach Approach and Prior Screening Behavior
timeFrame: Within 6 months of randomization
measure: Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior
timeFrame: Within 6 months of randomization
measure: Completion of Recommended Follow-up After a Positive Kit Result
timeFrame: Within 6 months of randomization
measure: Screening Method Choice
timeFrame: Within 6 months of randomization
measure: Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior
timeFrame: 6-12 months following study invitation
measure: Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior
timeFrame: 3-5 years (projected)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Beverly B Green, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Rachel L Winer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: