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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19851 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-02-28

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.

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Mailed in-home high-risk HPV testing kit

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

Interventions

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Mailed in-home high-risk HPV testing kit

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

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