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

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411849
• Other study ID #: OSU-20055
• Secondary ID: NCI-2020-01228P0
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Carcinoma
• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• Best Practice
Receive usual care

Procedure:
• HPV Self-Collection
Receive HPV self-testing intervention

Other:
• Informational Intervention
Receive information about cervical cancer

Behavioral:
• Patient Navigation Program
Receive telephone-based patient navigation

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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	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
Secondary	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

External Links

•   The Jamesline