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

University of Washington

Status: Completed

Conditions: Cervical Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02005510

44731

R01CA168598 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19,851 patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19,851 participants in 2 patient groups, including a placebo group

In-home HPV Screening

Experimental group

Description:

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.

Treatment:

Other: Usual care

Behavioral: Mailed in-home high-risk HPV testing kit

Usual Care

Placebo Comparator group

Description:

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.

Treatment:

Other: Usual care