Human Papillomavirus Infection Clinical Trial
Official title:
Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
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.
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.
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