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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005510
• Other study ID #: 44731
• Secondary ID: R01CA168598
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: February 2018

Study information

• Verified date: August 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19851
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Mailed in-home high-risk HPV testing kit

Other:
• Usual care

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Kaiser Permanente, National Cancer Institute (NCI), University of California, Davis, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse	Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse	Assessed for up to 12 months post-randomization
Primary	Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse	Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse	Assessed for up to 18 months post-randomization
Secondary	Number of Participants That Completed Uptake of Cervical Cancer Screening	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.	Assessed for up to 6 months post-randomization
Secondary	Number of Participants With an Abnormal Screening Result	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.	Assessed for up to 6 months post-randomization
Secondary	Experiences and Attitudes Associated With In-home HPV Testing Uptake	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). We will examine psychosocial factors (e.g., cervical cancer/HPV knowledge, attitudes toward screening), experiences, and reactions to kits. We will compare responses in women who do versus do not return a mailed HPV kit.	Survey invitation mailed 6 months post-randomization
Secondary	Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results	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). We will explore patient perspectives following a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality.	Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization