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

The Ohio State University

Status: Completed

Conditions: Human Papillomavirus Infection; Cervical Carcinoma

Treatments: Procedure: HPV Self-Collection; Other: Informational Intervention; Behavioral: Patient Navigation Program; Other: Best Practice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04411849

NCI-2020-01228 (Registry Identifier)

OSU-20055

P01CA229143 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 802 patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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802 participants in 2 patient groups

Group I (intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Patient Navigation Program

Other: Informational Intervention

Procedure: HPV Self-Collection

Group II (usual care continued)

Active Comparator group

Description:

Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Treatment:

Other: Best Practice

Other: Informational Intervention