HPV Self-Test Intervention in Ohio Appalachia

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.

Inclusion Criteria:

- 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