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

Not Applicable

Completed

• Conditions: Human Papillomavirus Infection; Cervical Carcinoma
• Interventions: Other: Best Practice; Procedure: HPV Self-Collection; Other: Informational Intervention; Behavioral: Patient Navigation Program

• Registration Number: NCT04411849
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2021-08-27
• Primary Completion: 2024-06-11
• Study Completion: 2024-06-11
• Status Verified: 2024-11
• Results First Submitted: 2024-11-05
• Results First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Results First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 802

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (usual care continued)	HPV Self-Collection	Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
Group II (usual care continued)	Patient Navigation Program	Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
Group I (intervention)	Informational Intervention	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 (usual care continued)	Best Practice	Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
Group I (intervention)	HPV Self-Collection	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 I (intervention)	Patient Navigation Program	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 (usual care continued)	Informational Intervention	Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Primary Outcome Measures

Name	Time	Method
Effectiveness of Human Papillomavirus (HPV) Intervention	Up to 1 years	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.

Trial Locations

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