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| ID | Type | Description | Link |
|---|---|---|---|
| MISP# 101971 | Other Grant/Funding Number | Merck Investigator Studies Program (MISP) |
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Slow pace of recruitment
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Under-immunized Emergency Department adult patients | Adults attending the Emergency Department who are aged 18-45, without previous HPV vaccination history and without previously known infection from HPV high-risk strain, and in good functional capacity. Eligible participants will receive Gardasil 9 (HPV) vaccination if interested. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil 9 | Biological | Prevent HPV-associated diseases and cancers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of study participants who receive HPV vaccination at baseline | HPV vaccination will be administered at the time of the study participant's initial visit (baseline) | Baseline |
| Number of study participants who receive HPV vaccination at 2 months | Number of study participants receiving dose 2 of the HPV vaccination series 2 months after initial study visit | 2 months |
| Number of study participants who receive HPV vaccinations at 6 months | Number of study participants receiving dose 3 of the HPV vaccination series 6 months after initial study visit | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Pre-existing ED-patients in the waiting room who fit the eligibility criteria, as per the chart review which will indicate the participant's age, and if the participant is in good functional capacity, as determined by the ED-attending clinician, and if the participant has no known infection with HPV high risk strain types 6, 11, 16 and 18. Participants running fever or in pain at the time of the initial ED visit and still interested in receiving HPV vaccination, will be offered to come back for HPV vaccination when in good health at a later date.
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| Name | Affiliation | Role |
|---|---|---|
| Andrzej Kulczycki, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0022 | United States |
All Study data and results will be owned by the University of Alabama at Birmingham (UAB). UAB agrees that all Study data and results generated during the course of the Study may be used fully by Merck for any legitimate business purpose without any additional payments being made to UAB or the PI. Merck agrees not to publish the research data and results generated during the Study until the PI's publication or presentation of the Study results in accordance with Article 9, or 18 months following study completion or termination of this Agreement, whichever occurs first. Merck may disclose the research data and results to health authorities if such disclosure is prior to publication. Merck shall use reasonable efforts to disclose such research data and results confidentially. UAB agrees not to provide any commercial third party with access to or with the right to use the unpublished data or results for any purpose without Merck's permission which shall not be unreasonably withheld.
Article 9, or eighteen (18) months following completion of the Study or termination of this Agreement, whichever occurs first.
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| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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