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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU IRB 23478 | Other Identifier | OHSU Institutional Review Board |
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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
| Oregon Health and Science University | OTHER |
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This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.
This will be a prospective, randomized study of women ages 25 and older, stratified by menopausal status (defined as 12 months or greater without menses or time at which both ovaries have been surgically removed), who are eligible for cervical cancer screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive routine instructions | Active Comparator | Participants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit |
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| Telehealth Visit | Active Comparator | Participants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receive routine instructions | Other | Study subjects randomized to this arm will receive a mailed myLab Box kit with instructions on HPV self-collection and postage to be shipped directly to the commercial lab. It should take less than 5 minutes to collect the sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants preferring self-collection to provider collection | In follow-up survey, participants will indicate how the would prefer to have their next cervical cancer screening performed: by their healthcare provider or by self-testing. | Post-intervention: 2 weeks after receipt of test results |
| Measure | Description | Time Frame |
|---|---|---|
| Median perceived difficulty understanding self-collection instructions | In follow-up survey, participants will indicate how difficult the self-collection instructions were to understand, on a 10-point Likert scale. | Post-intervention: 2 weeks after receipt of test results |
| Median discomfort level with self-collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Bruegl, MD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| Telehealth-based instructional visit and receive routine instructions | Other | Study subjects randomized to this arm will similarly receive a mailed myLab Box kit and also undergo a brief 5-10" telehealth instructional visit via video conference. |
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In follow-up survey, participants will indicate how much discomfort their experienced during self-collection, on a 10-point Likert scale. |
| Post-intervention: 2 weeks after receipt of test results |