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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00726 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (intervention) | Experimental | 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 (control) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disease Screening | Procedure | Complete HPV self-test |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of women who return HPV-self tests | A chi-square test will be used to test for a difference between the two groups. | Up to 4 weeks from kit distribution |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 months after notification letters are sent |
| Prevalence of HPV infection |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of a Pap test (received or not received) | Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm. | Up to 2 months after receiving notification letters are sent |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Reiter, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30461597 | Derived | 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. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| Educational Intervention | Other | 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 |
|
|
| Informational Intervention | Other | Receive standard instructions and information sheet |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Survey Administration | Other | Ancillary studies |
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm. |
| After shipping the specimen, an expected average of 6 weeks |
| 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. | After shipping the specimen, an expected average of 6 weeks |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |