General Pre-Trial Screening Protocol for Infectious Diseases Research

Healthy Volunteers Clinical Trial

Official title:

General Pre-Trial Screening Protocol for Enrollment of Volunteers Into Infectious Diseases Research Protocols

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463704
• Other study ID #: 2023P000266
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2034

Study information

• Verified date: June 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Kathryn E Stephenson, MD, MPH
• Phone: 617-735-4556
• Email: kstephen[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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:

1. Informed Consent process completed before any other study activities are conducted

2. Demographics

3. Medical history

4. Review of current medications

5. Targeted physical exam including vital signs

6. Behavioral risk assessment to determine risk of acquiring HIV

7. Contraception status

8. Blood or urine collection: on average, most safety screening laboratory tests will require no more than 60mL of blood which will be resulted in BIDMC's clinical laboratory. A urine sample may be collected for people of childbearing potential to determine pregnancy status.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 2034
• Est. primary completion date: June 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older at time of consent

• Available to participate for the planned duration of the clinical trials for which screening is being done

• Capable of giving signed informed consent

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

Related Conditions & MeSH terms

• Communicable Diseases
• Healthy Volunteers
• Infections

Intervention

Other:
• There is no intervention
There is no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of demographic variables	Race, ethnicity, gender and sex at birth	At enrollment
Primary	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