Skip to main content
OpenTrials
Completed

NCT Number: NCT02005510

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mailed in-home high-risk HPV testing kit

Behavioral

Usual Care

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2013
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.