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

NCT04679675CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Kaiser Permanente

Enrollment

32771

Start Date

2020-11-20

Completion Date

2022-07-29

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Usual CareEducationDirect MailOpt-in

Conditions

Uterine Cervical NeoplasmUterine NeoplasmsGenital NeoplasmsFemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesCervical CancerCervical DysplasiaHuman Papilloma VirusHPV-Related Cervical CarcinomaHPV InfectionHPV-Related Malignancy

Eligibility

Age Range

30 Years – 64 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Screening Completion by Outreach Approach and Prior Screening Behavior

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.

Time frame: Within 6 months of randomization

Secondary Outcomes

Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior

Incremental cost-effectiveness ratio, which will be defined for each outreach approach within each screening behavior subgroup. Also, comparisons across screening behavior subgroups of usual care plus education to usual care.

Time frame: Within 6 months of randomization

Screening Initiation by Outreach Approach and Prior Screening Behavior

Screening Initiation defined as returning the home kit or receiving in clinic cervical cancer screening.

Time frame: Within 6 months of randomization

Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior

Time from randomization to 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.

Time frame: Within 6 months of randomization

Completion of Recommended Follow-up After a Positive Kit Result

Proportion of intervention group women who complete recommended follow-up after a positive kit result by outreach approach and prior screening behavior. Per current guidelines, in-clinic Pap after other-HR HPV positive; or colposcopy after HPV 16/18+ HPV self-collection

Time frame: Within 6 months of randomization

Screening Method Choice

Proportion of intervention group women who do not screen, return the home kit or receive in-clinic screening by outreach approach and prior screening behavior. Screening uptake outcome (no screen, home kit, or in-clinic) by outreach approach and by prior screening behavior

Time frame: Within 6 months of randomization

Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior

Through focus groups, the investigators will explore patient preference for, and satisfaction with, home HPV screening and barriers to follow-up of abnormal screening results.

Time frame: 6-12 months following study invitation

Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior

Economic assessment of system-level financial consequences of adopting home-based HPV screening for cervical cancer. These analyses will evaluate the needed time to follow-up for the next cervical cancer screening to reduce gaps in cervical cancer screening HEDIS metrics, which also addresses program affordability.

Time frame: 3-5 years (projected)

Locations

Kaiser Permanente Washington Health Research Institute, Seattle, United States

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.

Linked Papers

Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits

ImportanceOptimal strategies for increasing cervical cancer screening may differ by patient screening history and health care setting. Mailing human papillomavirus (HPV) self-sampling kits to individuals who are overdue for screening increases adherence; however, offering self-sampling kits to screening-adherent individuals has not been evaluated in the US.ObjectiveTo evaluate the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (screening-adherent and currently due, overdue, or unknown).Design, Setting, and ParticipantsRandomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Individuals aged 30 to 64 years with female sex, a primary care clinician, and no hysterectomy were identified through electronic health records (EHRs) and enrolled between November 20, 2020, and January 28, 2022, with follow-up through July 29, 2022.InterventionsIndividuals stratified as due (eg, at the time of randomization, these individuals have been previously screened and are due for their next screening in ≤3 months) were randomized to receive usual care (patient reminders and clinician EHR alerts [n = 3671]), education (usual care plus educational materials about screening [n = 3960]), direct mail (usual care plus educational materials and a mailed self-sampling kit [n = 1482]), or to opt in (usual care plus educational materials and the option to request a kit [n = 3956]). Individuals who were overdue for screening were randomized to receive usual care (n = 5488), education (n = 1408), or direct mail (n = 1415). Individuals with unknown history for screening were randomized to receive usual care (n = 2983), education (n = 3486), or to opt in (n = 3506).Main Outcomes and MeasuresThe primary outcome was screening completion within 6 months. Primary analyses compared direct-mail or opt-in participants with individuals randomized to the education group.ResultsThe intention-to-treat analyses included 31 355 randomized individuals (mean [SD] age, 45.9 [10.4] years). Among those who were due for screening, compared with receiving education alone (1885 [47.6%]), screening completion was 14.1% (95% CI, 11.2%-16.9%) higher in the direct-mail group (914 [61.7%]) and 3.5% (95% CI, 1.2%-5.7%) higher in the opt-in group (2020 [51.1%]). Among individuals who were overdue, screening completion was 16.9% (95% CI, 13.8%-20.0%) higher in the direct-mail group (505 [35.7%]) compared with education alone (264 [18.8%]). Among those with unknown history, screening was 2.2% (95% CI, 0.5%-3.9%) higher in the opt-in group (634 [18.1%]) compared with education alone (555 [15.9%]).Conclusions and RelevanceWithin a US health care system, direct-mail self-sampling increased cervical cancer screening by more than 14% in individuals who were due or overdue for cervical cancer screening. The opt-in approach minimally increased screening. To increase screening adherence, systems implementing HPV self-sampling should prioritize direct-mail outreach for individuals who are due or overdue for screening. For individuals with unknown screening history, testing alternative outreach approaches and additional efforts to document screening history are warranted.Trial RegistrationClinicalTrials.gov Identifier: NCT04679675

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