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
Information provided by (Responsible Party):
Rachel Winer, University of Washington
ClinicalTrials.gov Identifier:
NCT02005510
First received: December 3, 2013
Last updated: March 6, 2014
Last verified: March 2014
  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: In-home HPV Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 University of Washington:

Primary Outcome Measures:
  • Diagnosed cervical epithelial neoplasia [ Time Frame: Assessed for 18 months post-randomization ] [ Designated as safety issue: No ]
    Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse.

  • Treated cervical intraepithelial neoplasia [ Time Frame: Assessed for 18 months post-randomization ] [ Designated as safety issue: No ]
    Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse


Secondary Outcome Measures:
  • Uptake of cervical cancer screening [ Time Frame: Assessed for 6 months post-randomization ] [ Designated as safety issue: No ]
    Uptake of cervical cancer screening is defined as either: receipt of a Pap test; [2] self-sample hrHPV-positive AND receipt of follow-up diagnostic testing (Pap test or colposcopy); or [3] self-sample hrHPV-negative)


Estimated Enrollment: 17600
Study Start Date: March 2014
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: In-home HPV Screening
Usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening PLUS a mailed in-home high-risk HPV testing kit.
Behavioral: In-home HPV Screening
Placebo Comparator: Usual Care
Usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening.

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 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 30 to 65 years of age
  • Have a primary care provider at Group Health
  • Received annual "birthday letter" with screening reminders 5 months earlier
  • No Pap test in the past 3.4 years
  • Continuously enrolled at Group Health for at least 3.4 years

Exclusion Criteria:

  • Hysterectomy
  • Currently pregnant
  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
Investigators
Principal Investigator: Rachel L Winer, PhD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Rachel Winer, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02005510     History of Changes
Other Study ID Numbers: 44731-K
Study First Received: December 3, 2013
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014