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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Behavioral: Mailed in-home high-risk HPV testing kit; Other: Usual care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19851 participants
• 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
• Official Title: Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
• Actual Study Start Date: February 2014
• Actual Primary Completion Date: February 2018
• Actual Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
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.	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.	Other: Usual care

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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.

2. 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.

3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Washington

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States, 98101

Sponsors and Collaborators

University of Washington

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

  Study Documents (Full-Text)

Documents provided by Rachel Winer, University of Washington:

Study Protocol and Statistical Analysis Plan  [PDF] March 17, 2015

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rachel Winer, Associate Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT02005510
• Other Study ID Numbers: 44731; R01CA168598 ( U.S. NIH Grant/Contract )
• First Posted: December 9, 2013
• Results First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Last Verified: August 2020

Keywords provided by Rachel Winer, University of Washington:

cervical cancer; screening; human papillomavirus; cervical intraepithelial neoplasia

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases