NCT02460237

HPV Self-Test Intervention in Ohio Appalachia

Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Carcinoma
• Human Papillomavirus Infection

Interventions

Type	Name	Description
PROCEDURE	Disease Screening	Complete HPV self-test
OTHER	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
OTHER	Informational Intervention	Receive standard instructions and information sheet
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-06-14
• Completion: 2017-03-15
• First posted: 2015-06-02
• Last updated: 2018-02-08

Locations

1 site across 1 country: United States