Triage Survey for Infectious Disease Eligibility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrooklyn Clinical Research
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
5 yearsSecondary outcomes
1
Clinical Trial Enrollment
Proportion of the clinical trial seeking population who enroll in industry-sponsored studies in infectious diseases therapeutic area.
Time frame
5 yearsOther outcomes
1
Disqualifying conditions
Prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical research for HIV, vaccines, and other infectious diseases.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov