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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06570733
Eligibility Criteria:
Inclusion Criteria:
1. Cisgender girls and women (16-25 years of age, inclusive)
2. Vaginal sex with a cisgender male partner in the last three months
3. CT, GC, or TV detected at screening
4. Willing to return for quarterly study visits
5. Not currently pregnant and not planning to become pregnant in the next 12 months
6. Using or willing to initiate a highly effective method of contraception\*
7. HIV-uninfected
8. Interested in initiating oral PrEP
9. No known contraindications to FTC or TDF
Exclusion Criteria:
1. At Screening or Enrollment, participant reports known adverse reaction to FTC or TDF.
2. At Screening or Enrollment, has single or dual rapid Antibody positive reactive HIV-1 test.
3. At Screening or Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
4. As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
5. Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
25 Years
Study:
NCT06570733
Study Brief:
Protocol Section:
NCT06570733