A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Carcinoma
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 802
- Locations
- 4
- Primary Endpoint
- Effectiveness of Human Papillomavirus (HPV) Intervention
- Status
- Completed
- Last Updated
- 7 months ago
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.
Investigators
Paul Reiter
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility 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
Exclusion Criteria
- Not provided
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.