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

NCT04411849 | Completed Results DMC

• 3 other identifiers: OSU-20055NCI-2020-01228P01CA229143
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 4

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.

Conditions

Cervical Carcinoma; Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I (intervention)

EXPERIMENTAL

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; Other: Informational Intervention; Behavioral: Patient Navigation Program

Group II (usual care continued)

ACTIVE COMPARATOR

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; Other: Informational Intervention

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group II (usual care continued)

HPV Self-Collection PROCEDURE

Receive HPV self-testing intervention

Also known as: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

Group I (intervention)

Informational Intervention OTHER

Receive information about cervical cancer

Group I (intervention); Group II (usual care continued)

Patient Navigation Program BEHAVIORAL

Receive telephone-based patient navigation

Also known as: Patient Navigator Program

Group I (intervention)

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Practice Guidelines as Topic; Standard of Care; Patient Navigation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management

Results Point of Contact

• Title: Dr. Paul Reiter
• Organization: Ohio State University

reiter.36@osu.edu

614-292-4803

Study Officials

• Paul Reiter, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: August 27, 2021
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: September 10, 2025
• Results First Posted: December 4, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)