Cervical Carcinoma, Human Papillomavirus Infection
Conditions
Keywords
HPV
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.
Interventions
PROCEDUREDisease Screening
Complete HPV self-test
OTHEREducational 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
OTHERInformational Intervention
Receive standard instructions and information sheet
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of women who return HPV-self tests | Up to 4 weeks from kit distribution | A chi-square test will be used to test for a difference between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend) | Up to 2 months after notification letters are sent | Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm. |
| Prevalence of HPV infection | After shipping the specimen, an expected average of 6 weeks | 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) | After shipping the specimen, an expected average of 6 weeks | Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Receipt of a Pap test (received or not received) | Up to 2 months after receiving notification letters are sent | Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm. |
Countries
United States
Outcome results
None listed