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

• ClinicalTrials.gov Identifier: NCT02005510
• Recruitment Status: Completed
• First Posted: December 9, 2013
• Results First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Sponsor: University of Washington
• Collaborators: Kaiser Permanente; University of Texas Southwestern Medical Center; National Cancer Institute (NCI); University of California, Davis
• Information provided by (Responsible Party): Rachel Winer, University of Washington

Tracking Information

• First Submitted Date: December 3, 2013
• First Posted Date: December 9, 2013
• Results First Submitted Date: January 20, 2020
• Results First Posted Date: September 16, 2020
• Last Update Posted Date: September 16, 2020
• Actual Study Start Date: February 2014
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2020)

• 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
• 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

Original Primary Outcome Measures (submitted: December 6, 2013)

• Diagnosed cervical epithelial neoplasia [ Time Frame: Assessed for 18 months post-randomization ]
  Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse.
• Treated cervical intraepithelial neoplasia [ Time Frame: Assessed for 18 months post-randomization ]
  Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse

Current Secondary Outcome Measures (submitted: August 27, 2020)

• Number of Participants That Completed Uptake of Cervical Cancer Screening [ Time Frame: Assessed for up to 6 months post-randomization ]
  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.
• Number of Participants With an Abnormal Screening Result [ Time Frame: Assessed for up to 6 months post-randomization ]
  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.
• Experiences and Attitudes Associated With In-home HPV Testing Uptake [ Time Frame: Survey invitation mailed 6 months post-randomization ]
  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.
• Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results [ Time Frame: Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization ]
  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.

Original Secondary Outcome Measures (submitted: December 6, 2013)

Uptake of cervical cancer screening [ Time Frame: Assessed for 6 months post-randomization ]

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)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
• Official Title: Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Investigator)
Primary Purpose: Screening

• Condition: Cervical Cancer

Intervention

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

Study Arms

• Experimental: In-home HPV Screening
  Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
  Interventions:

  • Behavioral: Mailed in-home high-risk HPV testing kit
  • Other: Usual care
• Placebo Comparator: Usual Care
  Usual care. "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
  Intervention: Other: Usual care

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 30, 2018): 19851
• Original Estimated Enrollment (submitted: December 6, 2013): 17600
• Actual Study Completion Date: February 2018
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 30 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02005510
• Other Study ID Numbers: 44731; R01CA168598 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rachel Winer, University of Washington
• Original Responsible Party: Rachel Winer, University of Washington, Assistant Professor
• Current Study Sponsor: University of Washington
• Original Study Sponsor: Same as current

Collaborators

• Kaiser Permanente
• University of Texas Southwestern Medical Center
• National Cancer Institute (NCI)
• University of California, Davis

Investigators

• Principal Investigator: Rachel L Winer, PhD, MPH; University of Washington

• PRS Account: University of Washington
• Verification Date: August 2020