Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
- Conditions
- Uterine DiseasesHPV-Related Cervical CarcinomaUterine NeoplasmsNeoplasmsUterine Cervical DiseasesUterine Cervical NeoplasmNeoplasms by SiteCervical CancerHuman Papilloma VirusHPV-Related Malignancy
- Interventions
- Other: Usual CareBehavioral: Direct MailBehavioral: EducationBehavioral: Opt-in
- Registration Number
- NCT04679675
- Lead Sponsor
- Kaiser Permanente
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32771
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care - Direct Mail Direct Mail - Education Education - Opt-in Opt-in -
- Primary Outcome Measures
Name Time Method Screening Completion by Outreach Approach and Prior Screening Behavior Within 6 months of randomization 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.
- Secondary Outcome Measures
Name Time Method Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior Within 6 months of randomization 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.
Screening Initiation by Outreach Approach and Prior Screening Behavior Within 6 months of randomization Screening Initiation defined as returning the home kit or receiving in clinic cervical cancer screening.
Screening Method Choice Within 6 months of randomization 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
Completion of Recommended Follow-up After a Positive Kit Result Within 6 months of randomization 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 From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior Within 6 months of randomization 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.
Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior 6-12 months following study invitation 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.
Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior 3-5 years (projected) 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.
Trial Locations
- Locations (1)
Kaiser Permanente Washington Health Research Institute
🇺🇸Seattle, Washington, United States