Triage Survey for Infectious Disease Eligibility

NCT06492187 | Recruiting

• 1 other identifier: SWIFT-ID-101
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

SWIFT-ID-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials for diagnosis, treatment, or prevention of infectious diseases such as in the areas of HIV, vaccines, and other infectious-diseases areas. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical/surgical history, physical examination, comorbidities, and any current symptoms. Informed consent will be done electronically (preferable) or on paper. Informed consent may be done in-person or remotely, depending on patient preference. Information related to HIV, hepatitis B and C, other infectious diseases, or substance use disorder will also be obtained if applicable. Site staff may collect vital signs, fingerpick testing, urine drug screens, blood draws, EKG, and pregnancy tests. Some testing may be recommended in a fasting condition. A doctor will review medical history and results of the above evaluations with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians, other providers, and pharmacies to determine eligibility for clinical trials. A follow-up phone call may be needed to discuss testing results and/or trial eligibility. If a participant is deemed eligible for future trials and if the participant remains interested, counseling on contraception requirements for trials will be discussed.

Conditions

Vaccination; Infection; HIV-1-infection; Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants interested in clinical research

  Number of participants for whom an industry-sponsored clinical research clinical research is clinically appropriate for HIV, vaccines, and other infectious diseases

  5 years

Secondary Outcomes (1)

• Clinical Trial Enrollment

  5 years

Other Outcomes (1)

• Disqualifying conditions

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In total of the program, we anticipate 10,000 participants of any sex, gender, age 18+, who have expressed interest in participating in a clinical trial of an investigational product such as device or drug, for indications in infectious diseases related therapeutic areas will be screened for clinical appropriateness for a study trial.

You may qualify if:

• \- 1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
• \. Participant is at least 18 years old.

You may not qualify if:

• Participants are pregnant, breast-feeding, or planning to become pregnant.
• History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results or makes them unsuitable for the study for another reason.
• Current or recent moderate or severe substance use disorder impacting their ability to follow study related procedures.
• Reported history of coagulopathy or bleeding disorder considered a contraindication to phlebotomy.
• Any condition that in the investigator's opinion makes a participant unsuitable for the clinical trial study.
• Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.

Sponsors & Collaborators

• Brooklyn Clinical Research: lead

Study Sites (1)

Brooklyn Clinical Research

Brooklyn, New York, 11226, United States

RECRUITING

MeSH Terms

Conditions

Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ammara Mushtaq, MD

CONTACT

9292035879; amushtaq@brooklynclinicalresearch.com

Katherine Azer, MS

CONTACT

9293327848; kazer@brooklynclinicalresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: June 28, 2024
• Primary Completion (Estimated): January 28, 2029
• Study Completion (Estimated): January 28, 2029
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

US (1)