Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia

Ohio State University Comprehensive Cancer Center802 enrolled

Overview

This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.

PRIMARY OBJECTIVES: Determine the effectiveness of the intervention in increasing cervical cancer screening. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

802

Conditions

Cervical Carcinoma Human Papillomavirus Infection

Interventions

Best PracticeOTHER

Receive usual care

HPV Self-CollectionPROCEDURE

Receive HPV self-testing intervention

Informational InterventionOTHER

Receive information about cervical cancer

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou \[Pap\] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years) * Resident of an Appalachian county * Not currently pregnant * Intact cervix * No history of invasive cervical cancer * Seen in a participating clinic/health system in last 2 years (i.e., active patient) * Have a working telephone

Locations (4)

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Virginia

Charlottesville, Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

Effectiveness of Human Papillomavirus (HPV) Intervention

The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system.

Time frame: Up to 1 years

Data from ClinicalTrials.gov

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