Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- University of Washington
- Enrollment
- 19851
- Locations
- 1
- Primary Endpoint
- Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
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.
Investigators
Rachel Winer
Associate Professor
University of Washington
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse
Time Frame: Assessed for up to 18 months post-randomization
Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse
Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse
Time Frame: Assessed for up to 12 months post-randomization
Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse
Secondary Outcomes
- Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results(Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization)
- Number of Participants That Completed Uptake of Cervical Cancer Screening(Assessed for up to 6 months post-randomization)
- Number of Participants With an Abnormal Screening Result(Assessed for up to 6 months post-randomization)
- Experiences and Attitudes Associated With In-home HPV Testing Uptake(Survey invitation mailed 6 months post-randomization)