Clinical trial NCT02005510: Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
Official title: Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
screening
human papillomavirus
cervical intraepithelial neoplasia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: University of Texas Southwestern Medical Center
name: National Cancer Institute (NCI)
name: University of California, Davis
First posted: 2013-12-09
Enrollment: 19851
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse
timeFrame: Assessed for up to 12 months post-randomization
measure: Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse
timeFrame: Assessed for up to 18 months post-randomization
Secondary outcomes:
measure: Number of Participants That Completed Uptake of Cervical Cancer Screening
timeFrame: Assessed for up to 6 months post-randomization
measure: Number of Participants With an Abnormal Screening Result
timeFrame: Assessed for up to 6 months post-randomization
measure: Experiences and Attitudes Associated With In-home HPV Testing Uptake
timeFrame: Survey invitation mailed 6 months post-randomization
measure: Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results
timeFrame: Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: University of Washington
name: Rachel L Winer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winer RL, Lin J, Tiro JA, Miglioretti DL, Beatty T, Gao H, Kimbel K, Thayer C, Buist DSM. Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914729. doi: 10.1001/jamanetworkopen.2019.14729.