Triage Survey for Infectious Disease Eligibility

Brooklyn Clinical Research10,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Vaccination; Infection HIV-1-infection Infectious Disease

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

Clinical Trial Enrollment

Proportion of the clinical trial seeking population who enroll in industry-sponsored studies in infectious diseases therapeutic area.