Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Communicable Diseases

Papillomavirus Infections

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Papilloma

Virus Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Precancerous Conditions

Male Urogenital Diseases

Cervical Intraepithelial Neoplasia

Subjects will receive Kaiser Permanente Washington standard of care.

Usual 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.

Education

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.

Direct Mail

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.

Opt-in

Beverly B Green, MD, MPH

Rachel L Winer, PhD, MPH

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.

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.

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).

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

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

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.

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.

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

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.

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

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

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.

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.

National Cancer Institute (NCI)

University of Washington

University of Texas Southwestern Medical Center

Kaiser Permanente

Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.

Usual Care: Subjects will receive Kaiser Permanente Washington standard of care.

Education: 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 Mail: 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-in: 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.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Beverly Green

Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Direct-Mail versus Education analysis.

Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Opt-In versus Education analysis.

Primary analysis stratified by screening history. These results are for Screening-Overdue (population):Direct-Mail versus Education analysis.

Primary analysis stratified by screening history. These results are for Screening-Unknown (population):Opt-In versus Education analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial	NCT04679675	Uterine Cervica... Uterine Neoplas... Genital Neoplas... Urogenital Neop... Neoplasms by Si... Neoplasms Uterine Cervica... Uterine Disease... Cervical Cancer Cervical Dyspla... Human Papilloma... HPV-Related Cer... HPV Infection HPV-Related Mal...	Usual Care Education Direct Mail Opt-in	30 Years - 64 Years	Kaiser Permanente
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial	NCT04679675	Uterine Cervica... Uterine Neoplas... Genital Neoplas... Urogenital Neop... Neoplasms by Si... Neoplasms Uterine Cervica... Uterine Disease... Cervical Cancer Cervical Dyspla... Human Papilloma... HPV-Related Cer... HPV Infection HPV-Related Mal...	Usual Care Education Direct Mail Opt-in	30 Years - 64 Years	Kaiser Permanente
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial	NCT04679675	Uterine Cervica... Uterine Neoplas... Genital Neoplas... Urogenital Neop... Neoplasms by Si... Neoplasms Uterine Cervica... Uterine Disease... Cervical Cancer Cervical Dyspla... Human Papilloma... HPV-Related Cer... HPV Infection HPV-Related Mal...	Usual Care Education Direct Mail Opt-in	30 Years - 64 Years	Kaiser Permanente

Spots Global Cancer Trial Database for direct mail

Every month we try and update this database with for direct mail cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for direct mail

Every month we try and update this database with for direct mail cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for direct mail cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.