Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
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.
|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|
- 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
- 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;  self-sample hrHPV-positive AND receipt of follow-up diagnostic testing (Pap test or colposcopy); or  self-sample hrHPV-negative)
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005510
|United States, Washington|
|Group Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Rachel L Winer, PhD, MPH||University of Washington|