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Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Group Health Cooperative
University of Texas Southwestern Medical Center
National Cancer Institute (NCI)
University of California, Davis
Information provided by (Responsible Party):
Rachel Winer, University of Washington
ClinicalTrials.gov Identifier:
NCT02005510
First received: December 3, 2013
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women.

Condition Intervention
Cervical Cancer Behavioral: Mailed in-home high-risk HPV testing kit Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligibility is assessed weekly over 2.5 years. Study participants are assigned to the control arm or to the intervention arm. After follow-up is complete, control arm participants are re-assessed for eligibility and re-randomization.
Masking: Investigator
Primary Purpose: Screening
Official Title: Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women

Resource links provided by NLM:


Further study details as provided by Rachel Winer, University of Washington:

Primary Outcome Measures:
  • Diagnosed cervical epithelial neoplasia [ Time Frame: Assessed for up to 12 months post-randomization ]

    Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse

    Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for diagnosed cervical intraepithelial neoplasia grade 2 or worse for the in-home HPV screening arm versus the usual care arm.


  • Treated cervical intraepithelial neoplasia [ Time Frame: Assessed for up to 18 months post-randomization ]

    Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse

    Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for treated cervical intraepithelial neoplasia grade 2 or worse for the in-home HPV screening arm versus the usual care arm.



Secondary Outcome Measures:
  • Uptake of cervical cancer screening [ Time Frame: Assessed for up to 6 months post-randomization ]

    Uptake of cervical cancer screening is defined as either: [1] receipt of a Pap or co-test; [2] self-sample hrHPV-positive (16/18-negative) OR unsatisfactory AND receipt of follow-up diagnostic testing (Pap or co-test or colposcopy); [3] self-sample HPV16/18-positive; or [4] self-sample hrHPV-negative)

    Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for cervical cancer screening uptake for the in-home HPV screening arm versus the usual care arm.

    We will also use log-binomial regression to estimate the effects of EMR-derived patient characteristics (e.g. age, race/ethnicity, geocoded socioeconomic status, geocoded distance form primary care clinic, insurance type, time since last Pap test, tobacco use, obesity, and Charlson comorbidity score) on cervical cancer screening uptake, stratified subdivided by randomization arm.


  • Abnormal screening result [ Time Frame: Assessed for up to 6 months post-randomization ]

    Screening result that warrants repeat testing, surveillance, or immediate colposcopy (per current guidelines) before returning to a routine screening schedule

    Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for an abnormal screening result for the in-home HPV screening arm versus the usual care arm.


  • Experiences and attitudes associated with in-home HPV testing uptake [ Time Frame: Survey invitation mailed 6 months post-randomization ]
    Experiences and attitudes will be measured with online surveys. A subset of intervention arm participants who do and do not return the in-home HPV kit will be invited to complete a survey (target n=200)

  • Experiences and attitudes associated with follow-up of positive in-home HPV testing results [ Time Frame: Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization ]
    Intervention arm participants who return in-home HPV kits and test positive for HPV will be invited to complete an in-depth semi-structured interview (target n=50)


Estimated Enrollment: 17600
Actual Study Start Date: February 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: In-home HPV Screening
Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
Behavioral: Mailed in-home high-risk HPV testing kit Other: Usual care
Placebo Comparator: Usual Care
Usual care. "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
Other: Usual care

Detailed Description:
Over half of all cervical cancers in the U.S. are diagnosed in unscreened or underscreened women. New national guidelines identify increasing screening uptake as the number one priority for reducing cervical cancer-related morbidity and mortality. Innovative screening strategies that eliminate the need for clinic-based screening could be highly effective in improving screening compliance while maintaining high-quality care. We propose a large, pragmatic randomized controlled trial within Group Health (a large integrated health care delivery system in Washington State) to compare effectiveness of two programmatic approaches to increasing cervical cancer screening among overdue women. The first approach (control arm) is usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening, and the second approach (intervention arm) includes usual care plus a mailed in-home high-risk human papillomavirus (hrHPV) screening kit. We will randomize eligible women to the in-home hrHPV screening arm or the usual care arm. Compared to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and treatment of cervical neoplasia and improve compliance with screening. The trial will provide definitive evidence-based data on the impact of an in-home hrHPV screening program in a real-world clinical setting.
  Eligibility

Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 30 to 64 years of age
  • Have a primary care provider at Group Health
  • Received annual "birthday letter" with Pap screening reminder 5 months earlier
  • No Pap test in the past 3.4 years
  • Continuously enrolled at Group Health for at least 3.4 years
  • No hysterectomy

Exclusion Criteria:

  • Currently pregnant
  • Language interpreter needed
  • On "do not contact list" for research studies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005510

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Washington
Group Health Cooperative
University of Texas Southwestern Medical Center
National Cancer Institute (NCI)
University of California, Davis
Investigators
Principal Investigator: Rachel L Winer, PhD, MPH University of Washington
  More Information

Responsible Party: Rachel Winer, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02005510     History of Changes
Other Study ID Numbers: 44731-K
R01CA168598 ( US NIH Grant/Contract Award Number )
Study First Received: December 3, 2013
Last Updated: February 21, 2017

Keywords provided by Rachel Winer, University of Washington:
cervical cancer
screening
human papillomavirus
cervical intraepithelial neoplasia

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 28, 2017