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Purpose

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

Eligibility

Eligible Ages
Between 30 Years and 64 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Criteria


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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Mark Dingnan, PhD, MPH
859-323-4708
mbdign2@uky.edu

More Details

NCT ID
NCT04411849
Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.