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

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

  • Cervical Carcinoma
  • Human Papillomavirus Infection

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.