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The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) or Division of Infectious Diseases at Beth Israel Deaconess Medical Center. This general screening protocol will help to determine the eligibility of potential volunteers for any vaccine or therapeutic trials open for recruitment or soon to be opened.
The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) and Division of Infectious Diseases at Beth Israel Deaconess Medical Center. This protocol will help us to determine whether a volunteer is eligible for completing the screening process and which protocols might best be suited to the participant.
Volunteers will be adults interested in participating in a clinical trial, such as a vaccine or therapeutic study, and particularly for studies conducted as part of the HIV Vaccine Trials Network. Occasionally, the screening protocol may be used for an observational study. This general screening protocol will help to determine the eligibility of potential volunteers for any clinical trials open for recruitment or soon to be opened. No investigational products will be administered under this protocol. All main vaccine or intervention studies will be submitted as separate applications to the appropriate regulatory agency as required by the sponsor.
Prescreening of volunteers may be done via telephone using an already approved script and RedCap questionnaire. Following the prescreening, the volunteer will be scheduled for an in-person clinic visit with a study clinician (MD, NP or RN). All participants in this study will be screened for safety, including a physical exam, vital signs and laboratory testing. This is to ensure that participants meet the appropriate inclusion and exclusion criteria related to safety in a clinical trial. The following study procedures will be performed at the Clinical Research Center at BIDMC:
Laboratory tests will be checked against eligibility criteria of open or soon-to-be opened clinical trials. If a test or exam result suggest that further medical evaluation or treatment may be necessary, the participant will be notified and referred to their care provider for further treatment. A copy of test results will be provided if requested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational cohort for potential study volunteers | This is a general screening protocol to develop a registry of potential volunteers for our clinical trials. There is no intervention to be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no intervention | Other | There is no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of demographic variables | Race, ethnicity, gender and sex at birth | At enrollment |
| Number of participants who subsequently enroll in another study | The number of participants in the general screening protocol who go on to enroll in another study | From date of enrollment until the date of enrollment in a subsequent study or up to 52 weeks, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
• A condition, based on clinical judgement, which requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being
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Volunteers will be adults interested in participating in a clinical trial, such as a vaccine or therapeutic study, and particularly for studies conducted as part of the HIV Vaccine Trials Network.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn E Stephenson, MD, MPH | Contact | 617-735-4556 | kstephen@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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