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:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT03142256
Eligibility Criteria:
Inclusion Criteria:
* Female at birth
* HIV uninfected at screening and enrollment
* Age 16-25 years old at screening, inclusive
* Per participant report, sexually active, defined as having vaginal or anal intercourse with a male partner at least once in the month prior to screening
* Willing and able to provide informed consent
* Able and willing to provide adequate locator information
Exclusion Criteria:
* Not planning to be in the area for periods longer than a month in the first three months and longer than 3 months from Month 3 - 12
* A positive HIV test at Enrollment, even if subsequent testing indicates that the person is HIV-1 uninfected
* Renal dysfunction (Creatinine Clearance \<60 mL/min, Cockroft Gault equation)
* Previous participation in an oral PrEP study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
25 Years
Study:
NCT03142256
Study Brief:
Protocol Section:
NCT03142256