HPV Self-Test Intervention in Ohio Appalachia

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.

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.

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.

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

Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)

Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.

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)

Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.

Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.

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

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.