Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT03996018
Eligibility Criteria:
Inclusion Criteria:
* Criteria • Participant is greater than or equal to 18 years of age.
Group 1 (HIV Uninfected) Only
* Participant is HIV negative per antibody screen conducted on premises
* Participant is enrolled on HPTN 083 study (receiving HIV-PrEP) (see Recruitment and Screening).
Group 2 (HIV Infected) Only
* Participant has initiated ART therapy as a patient at St Jude Children's Research Hospital
\*Note: participants will be allowed to continue on study and have data analyzed regardless of presence of detectable HIV or CD4+ counts.
a) Newly diagnosed HIV
* Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis within 90 days prior to enrollment
b) Prolonged HIV
* Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis more than 365 days prior to enrollment
Exclusion Criteria:
* Participant is unable or unwilling to provide informed consent.
* If female of child bearing potential, participant has a positive urine pregnancy test at screening. Note: if participant becomes pregnant while on study, they may not continue on study.
* Concurrent enrollment on a research study or receiving treatment for concurrent medical diagnosis with any of the following interventions which may impact study outcomes: high dose or prolonged steroids, chemotherapy to treat malignancy, radiation therapy, biologic pharmaceutical treatments that induce immunosuppression.
* If in the opinion of the investigator, participation in the blood draw would endanger the health of the participant.
* Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03996018
Study Brief:
Protocol Section:
NCT03996018