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NCT Number: NCT06492187

Triage Survey for Infectious Disease Eligibility

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.

Recruiting

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Key information

Conditions

Vaccination; Infection Communicable Diseases Disease Attributes HIV-1-infection Infections Infectious Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of participants interested in clinical research

    Time frame: 5 years

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

Secondary outcomes

  1. Clinical Trial Enrollment

    Time frame: 5 years

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

Other outcomes

  1. Disqualifying conditions

    Time frame: 5 years

    Prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical research for HIV, vaccines, and other infectious diseases.

Study contacts

Contact information is provided by the study sponsor or research team.

Ammara Mushtaq, MD

CONTACT

[email protected]

9292035879

Katherine Azer, MS

CONTACT

[email protected]

9293327848

Sponsors and collaborators

Lead sponsor

Brooklyn Clinical Research

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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