Uterine Cervical NeoplasmSTEPNCT04679675

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

A study testing Education, Direct Mail and Opt-in in people with Uterine Cervical Neoplasm and Uterine Neoplasms, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 64 years, women only
Conditions the study is for: Uterine Cervical Neoplasm, Uterine Neoplasms, Genital Neoplasms, Female
What is being tested?: Education, Direct Mail and Opt-in
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32,771 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2020to 29 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 64 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

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

Read the 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.

Conditions: Uterine Cervical Neoplasm, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms, Neoplasms by Site, Neoplasms
Being tested: Usual Care, Education, Direct Mail, Opt-in
Keywords: Cancer Screening
Medical subject headings: Uterine Cervical Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Uterine Cervical Diseases, Uterine Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Usual CareOther
Subjects will receive Kaiser Permanente Washington standard of care.
EducationBehavioural
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.
Direct MailBehavioural
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.
Opt-inBehavioural
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.

Study groups in NCT04679675
Study group	Role	What they receive
Usual Care	Active comparator	Not described Receives: Other: Usual Care
Education	Active comparator	Not described Receives: Behavioral: Education
Direct Mail	Active comparator	Not described Receives: Behavioral: Direct Mail
Opt-in	Active comparator	Not described Receives: Behavioral: Opt-in

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 6 months of randomization

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3-5 years (projected)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202029 Jul 2023

First posted22 Dec 2020
Study start20 Nov 2020
Primary completion29 Jul 2022
Study completion29 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Investigator
Enrolment: 32,771 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04679675
Sponsor's protocol ID: 00002344
Other IDs: R01CA240375
Acronym: STEP
Status last verified: Sep 2023
First submitted: 9 Dec 2020
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Resources developed during the study will be made available in accordance with the NIH Data Sharing Policy to researchers in both the private and public sector free or for a nominal charge and with minimal restriction. Deidentified data will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes. Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants or to disclose Kaiser Permanente proprietary information; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by Kaiser Permanente's Human Subjects Review Committee.

Publications

Tiro JA, Metcalfe S, Muthukrishnan M, Jose A, Hansen K, Lin J, Dorsey CN, Gao H, Lacey C, Anderson ML, Meenan RT, Green BB, Buist DSM, Sparks A, Winer RL. Promoting cervical cancer screening via a mailed HPV self-collection kit: Reactions from screeners and non-screeners. Patient Educ Couns. 2026 Jan;142:109374. doi: 10.1016/j.pec.2025.109374. Epub 2025 Oct 3.
PubMed 41067140
Winer RL, Lin J, Anderson ML, Tiro JA, Green BB, Gao H, Meenan RT, Hansen K, Sparks A, Buist DSM. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1971-1981. doi: 10.1001/jama.2023.21471.
PubMed 38015219

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial
ClinicalTrials.gov ID: NCT04679675
Acronym / sponsor ID: STEP / 00002344
Conditions: Uterine Cervical Neoplasm, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms, Neoplasms by Site, Neoplasms
Keywords: Cancer Screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 32,771 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), University of Washington, University of Texas Southwestern Medical Center
Study start: 20 Nov 2020 (actual)
Primary completion: 29 Jul 2022 (actual)
Study completion: 29 Jul 2023 (actual)
First posted: 22 Dec 2020 (actual)
Results: Posted 24 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4
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).

Arm	Type	Receives
Usual Care	Active comparator	Other: Usual Care
Education	Active comparator	Behavioral: Education
Direct Mail	Active comparator	Behavioral: Direct Mail
Opt-in	Active comparator	Behavioral: Opt-in

Who may qualify

Ages: 30 to 64 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Usual CareSubjects will receive Kaiser Permanente Washington standard of care.	Other	Usual Care
EducationParticipants 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.	Behavioural	Education
Direct MailParticipants 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.	Behavioural	Direct Mail
Opt-inParticipants 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.	Behavioural	Opt-in

Primary outcome

Screening Completion by Outreach Approach and Prior Screening Behavior
Time frame: 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.

7 secondary outcomes

Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior
Time frame: Within 6 months of randomization
Screening Initiation by Outreach Approach and Prior Screening Behavior
Time frame: Within 6 months of randomization
Time From Randomization to Screening Completion by Outreach Approach and Prior Screening Behavior
Time frame: Within 6 months of randomization
Completion of Recommended Follow-up After a Positive Kit Result
Time frame: Within 6 months of randomization
Screening Method Choice
Time frame: Within 6 months of randomization
Qualitative Information From Focus Groups on Patient Preferences by Prior Screening Behavior
Time frame: 6-12 months following study invitation
Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior
Time frame: 3-5 years (projected)

Results and safety

Results posted to the registry on 24 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	12,709	12,142
Education	9,279	8,854
Direct Mail	2,974	2,897
Opt-in	7,809	7,462

Primary outcome: Screening Completion by Outreach Approach and Prior Screening Behavior

Time frame: Within 6 months of randomization. Count of participants. Unit: Participants

Measure	Usual Care n = 12142	Education n = 8854	Direct Mail n = 2897	Opt-in n = 7462
Screening-Adherent	3671	3960	1482	3956
Overdue	5488	1408	1415	0
Unknown	2983	3486	0	3506

Education vs Direct Mail: Risk Ratio (RR): 1.30 (95% CI 1.23 to 1.36), p = 0.05, Poisson Regression with GEE
Education vs Opt-in: Risk Ratio (RR): 1.07 (95% CI 1.02 to 1.12), p = .05, Poisson Regression with GEE
Education vs Direct Mail: Risk Ratio (RR): 1.90 (95% CI 1.68 to 2.16), p = .05, Poisson Regression with GEE

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected within 6 months of randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 12,142 (0%)	0 of 12,142 (0%)	0 of 12,142
Education	0 of 8,854 (0%)	0 of 8,854 (0%)	0 of 8,854
Direct Mail	0 of 2,897 (0%)	4 of 2,897 (0.1%)	0 of 2,897
Opt-in	0 of 7,462 (0%)	3 of 7,462 (0%)	0 of 7,462

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41067140Tiro JA, Metcalfe S, Muthukrishnan M, Jose A, Hansen K, Lin J, Dorsey CN, Gao H, Lacey C, Anderson ML, Meenan RT, Green BB, Buist DSM, Sparks A, Winer RL. Promoting cervical cancer screening via a mailed HPV self-collection kit: Reactions from screeners and non-screeners. Patient Educ Couns. 2026 Jan;142:109374. doi: 10.1016/j.pec.2025.109374. Epub 2025 Oct 3.
Derived from this study: PubMed 38015219Winer RL, Lin J, Anderson ML, Tiro JA, Green BB, Gao H, Meenan RT, Hansen K, Sparks A, Buist DSM. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1971-1981. doi: 10.1001/jama.2023.21471.
Individual participant dataSharing planned: Yes. Resources developed during the study will be made available in accordance with the NIH Data Sharing Policy to researchers in both the private and public sector free or for a nominal charge and with minimal restriction. Deidentified data will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes. Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants or to disclose Kaiser Permanente proprietary information; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by Kaiser Permanente's Human Subjects Review Committee.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beverly B Green, MD, MPH principal investigator

Kaiser Permanente

Rachel L Winer, PhD, MPH principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Education, Direct Mail and Opt-in in people with Uterine Cervical Neoplasm and Uterine Neoplasms, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Screening Completion by Outreach Approach and Prior Screening Behavior (time frame: Within 6 months of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04679675, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.