HPV Self-Test Intervention in Ohio Appalachia
- Conditions
- Cervical CarcinomaHuman Papillomavirus Infection
- Interventions
- Procedure: Disease ScreeningOther: Educational InterventionOther: Informational InterventionOther: Laboratory Biomarker AnalysisOther: Survey Administration
- Registration Number
- NCT02460237
- Brief Summary
This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy. The intervention group will receive culturally appropriate materials and the control group will receive standard materials with their HPV self-test device.
- Detailed Description
PRIMARY OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
- Ages 30-65
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (intervention) Educational 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. Arm II (control) Disease Screening 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. Arm I (intervention) Disease Screening 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 (control) Survey Administration 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. Arm I (intervention) Laboratory Biomarker Analysis 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 I (intervention) Survey Administration 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 (control) Informational Intervention 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. Arm II (control) Laboratory Biomarker Analysis 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.
- Primary Outcome Measures
Name Time Method The proportion of women who return HPV-self tests Up to 4 weeks from kit distribution A chi-square test will be used to test for a difference between the two groups.
- Secondary Outcome Measures
Name Time Method Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend) Up to 2 months after notification letters are sent Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
Specimen adequacy (whether participants self-collected an adequate specimen [yes or no] to allow for HPV testing) After shipping the specimen, an expected average of 6 weeks Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
Prevalence of HPV infection After shipping the specimen, an expected average of 6 weeks Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States