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

A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 802
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Markey Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (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.	Procedure: HPV Self-Collection; Receive HPV self-testing intervention; Other Names: At-home HPV Self Collection; HPV Self Collection; Human Papillomavirus Self-Collection; Other: Informational Intervention; Receive information about cervical cancer; Behavioral: Patient Navigation Program; Receive telephone-based patient navigation; Other Names: Patient Navigator Program
Active Comparator: Group II (usual care continued); Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Informational Intervention; Receive information about cervical cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of HPV intervention	Will descriptively examine data from the patient satisfaction survey to see if women report any issues about using their HPV self-test.	Up to 5 years
Satisfaction with HPV self-testing and PN	Patient-level satisfaction data will come from the patient satisfaction surveys sent to women. Will examine satisfaction with both the HPV self-test device (appearance, usability, return process, etc.) and its instructions (appearance, readability, etc.).	Up to 5 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Uterine Cervical Neoplasms; Papillomavirus Infections; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Standard of Care; Practice Guidelines as Topic; Patient Navigation
• Other Study ID Numbers: OSU-20055; P01CA229143 (U.S. NIH Grant/Contract); NCI-2020-01228 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No