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

January 12, 2024 updated by: Paul Reiter, Ohio State University Comprehensive Cancer Center

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Mark Dingnan, PhD, MPH
        • Contact:
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Paul Reiter
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Melissa Little, PhD, MPH
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of human papillomavirus (HPV) intervention
Time Frame: Up to 5 years
The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women from year 2 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 clinic. Will examine the proportion of HPV self-test returners who returned their self-test following receipt of patient navigation (PN). Will use GLMMs with a logit link to examine potential differences in the proportion of women screened across project years within each treatment group (i.e., comparing years 2, 3, 4, and 5 for Group 1).
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of HPV intervention
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Paul Reiter, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 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)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Carcinoma

Clinical Trials on Best Practice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe