Vaccination; InfectionNCT06492187
Triage Survey for Infectious Disease Eligibility
An observational study of Vaccination; Infection and HIV-1-infection, run by Brooklyn Clinical Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection, HIV-1-infection, Infectious Disease
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2024to 28 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooklyn Clinical Research
Brooklyn, New York, 11226
Ammara Mushtaq, MD, 929-203-5879, amushtaq@brooklynclinicalresearch.com
Katherine Azer, MS, 9293327848, kazer@brooklynclinicalresearch.com
About this study
Official title: 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.
- Conditions
- Vaccination; Infection, HIV-1-infection, Infectious Disease
- Medical subject headings
- Infections, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Clinical Trial Enrollment
Proportion of the clinical trial seeking population who enroll in industry-sponsored studies in infectious diseases therapeutic area.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start28 Jun 2024
- Primary completion28 Jan 2029 (estimated)
- Study completion28 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooklyn Clinical Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492187
- Sponsor's protocol ID
- SWIFT-ID-101
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage Survey for Infectious Disease Eligibility (SWIFT-ID-101)
- ClinicalTrials.gov ID
- NCT06492187
- Acronym / sponsor ID
- SWIFT-ID-101
- Conditions
- Vaccination; Infection, HIV-1-infection, Infectious Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Brooklyn Clinical ResearchResearch network
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 28 Jan 2029 (estimated)
- Study completion
- 28 Jan 2029 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Clinical Trial Enrollment
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination; Infection and HIV-1-infection, run by Brooklyn Clinical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ammara Mushtaq, MD (9292035879, amushtaq@brooklynclinicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants interested in clinical research (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.