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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Trial Enrollment | Proportion of the clinical trial seeking population who enroll in industry-sponsored studies in infectious diseases therapeutic area. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disqualifying conditions | Prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical research for HIV, vaccines, and other infectious diseases. | 5 years |
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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ammara Mushtaq, MD | Contact | 9292035879 | amushtaq@brooklynclinicalresearch.com | |
| Katherine Azer, MS | Contact | 9293327848 | kazer@brooklynclinicalresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooklyn Clinical Research | Recruiting | Brooklyn | New York | 11226 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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