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Completed

NCT Number: NCT04411849

Multilevel HPV Self-Testing Intervention for the Increase of 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.

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Key information

Conditions

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

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

HPV Self-Collection

Procedure

Receive HPV self-testing intervention

Other names: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

Informational intervention

Other

Receive information about cervical cancer

Patient Navigation Program

Behavioral

Receive telephone-based patient navigation

Other names: Patient Navigator Program

Primary outcomes

  1. Effectiveness of Human Papillomavirus (HPV) Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2020
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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