Clinical trial NCT02460237: HPV Self-Test Intervention in Ohio Appalachia
Official title: Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Carcinoma
Human Papillomavirus Infection
Keywords: HPV
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 103
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of women who return HPV-self tests
timeFrame: Up to 4 weeks from kit distribution
Secondary outcomes:
measure: Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)
timeFrame: Up to 2 months after notification letters are sent
measure: Prevalence of HPV infection
timeFrame: After shipping the specimen, an expected average of 6 weeks
measure: Specimen adequacy (whether participants self-collected an adequate specimen [yes or no] to allow for HPV testing)
timeFrame: After shipping the specimen, an expected average of 6 weeks
Other outcomes:
measure: Receipt of a Pap test (received or not received)
timeFrame: Up to 2 months after receiving notification letters are sent
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Paul Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.