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Recruiting NCT06492187

Triage Survey for Infectious Disease Eligibility

Observational Vaccination; Infection HIV-1-infection Infectious Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vaccination; Infection, HIV-1-infection, Infectious Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Primary outcome measures

  • Number of participants interested in clinical research [Time frame: 5 years]
Secondary outcome measures (1)
  • Clinical Trial Enrollment [Time frame: 5 years]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Brooklyn Clinical Research — Brooklyn

Identifiers

NCT: NCT06492187 · SWIFT-ID-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗