Triage Survey for Infectious Disease Eligibility

Triage Survey for Infectious Disease Eligibility (SWIFT-ID-101)

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.

Study Overview

• Status: Recruiting
• Conditions: Infectious Disease; HIV-1-infection; Vaccination; Infection

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Ammara Mushtaq, MD; Phone Number: 9292035879; Email: amushtaq@brooklynclinicalresearch.com
• Study Contact Backup: Name: Katherine Azer, MS; Phone Number: 9293327848; Email: kazer@brooklynclinicalresearch.com

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11226
      • Recruiting
      • Brooklyn Clinical Research
      • Contact: Ammara Mushtaq, MD; Phone Number: 929-203-5879; Email: amushtaq@brooklynclinicalresearch.com
      • Principal Investigator: Ammara Mushtaq, MD
      • Contact: Katherine Azer, MS; Phone Number: 9293327848; Email: kazer@brooklynclinicalresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

- 1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.

2. Participant is at least 18 years old.

Exclusion Criteria:

1. Participants are pregnant, breast-feeding, or planning to become pregnant.
2. 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.
3. Current or recent moderate or severe substance use disorder impacting their ability to follow study related procedures.
4. Reported history of coagulopathy or bleeding disorder considered a contraindication to phlebotomy.
5. Any condition that in the investigator's opinion makes a participant unsuitable for the clinical trial study.
6. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Trial Enrollment	Proportion of the clinical trial seeking population who enroll in industry-sponsored studies in infectious diseases therapeutic area.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disqualifying conditions	Prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical research for HIV, vaccines, and other infectious diseases.	5 years

Collaborators and Investigators

• Sponsor: Brooklyn Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Estimated): January 28, 2029
• Study Completion (Estimated): January 28, 2029

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: SWIFT-ID-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No