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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Mailed in-home high-risk HPV testing kit
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-home HPV Screening<br>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<br> <br> Other: Usual care<br> <br> |
| Placebo Comparator: Usual Care<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, screening, human papillomavirus, cervical intraepithelial neoplasia