Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2015-11-30
2017-03-15
Brief Summary
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Detailed Description
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I. To determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use.
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I: Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing.
ARM II: Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing.
Participants are followed up at 4 weeks for return of their HPV self-test device and then for 2 months after notification letters are sent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm I (intervention)
Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing.
Disease Screening
Complete HPV self-test
Educational Intervention
Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing
Laboratory Biomarker Analysis
Correlative studies
Survey Administration
Ancillary studies
Arm II (control)
Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing.
Disease Screening
Complete HPV self-test
Informational Intervention
Receive standard instructions and information sheet
Laboratory Biomarker Analysis
Correlative studies
Survey Administration
Ancillary studies
Interventions
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Disease Screening
Complete HPV self-test
Educational Intervention
Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing
Informational Intervention
Receive standard instructions and information sheet
Laboratory Biomarker Analysis
Correlative studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No Pap test in the last 3 years
* Resident of an Ohio Appalachia county
* Not currently pregnant or was not pregnant in the last 3 months
* No history of invasive cervical cancer
* No history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board \[IRB\] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and Health Insurance Portability and Accountability Act (HIPAA) forms
30 Years
65 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Paul Reiter
Principal Investigator
Principal Investigators
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Paul Reiter, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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Reiter PL, Shoben AB, McDonough D, Ruffin MT, Steinau M, Unger ER, Paskett ED, Katz ML. Results of a Pilot Study of a Mail-Based Human Papillomavirus Self-Testing Program for Underscreened Women From Appalachian Ohio. Sex Transm Dis. 2019 Mar;46(3):185-190. doi: 10.1097/OLQ.0000000000000944.
Related Links
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The Jamesline
Other Identifiers
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NCI-2015-00726
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-14282
Identifier Type: -
Identifier Source: org_study_id
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