A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 802
- Locations
- 4
- Primary Endpoint
- Effectiveness of Human Papillomavirus (HPV) Intervention
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: HPV Self-Collection (Procedure)
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.
Intervention: Informational Intervention (Other)
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.
Intervention: Patient Navigation Program (Behavioral)
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.
Intervention: Best Practice (Other)
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.
Intervention: Informational Intervention (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Paul Reiter
Principal Investigator
Ohio State University Comprehensive Cancer Center