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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT03745495
Eligibility Criteria:
Inclusion Criteria:
1. Thai nationality
2. Age 15-19 years old
3. Men or transgender women who have sex with men
4. HIV-negative at the time of screening
5. Have at least one of the following risks for HIV acquisition in the past 6 months:
1. Any unprotected receptive anal sex with a male partner
2. More than 5 male partners, regardless of condom use and serostatus
3. Has had a bacterial sexually transmitted infection (STI)
4. Any injected drug use
6. Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation
7. Alanine aminotransferase (ALT) ≤ 2.5 x ULN
8. Have signed the informed consent form
Exclusion Criteria:
1. HIV-positive
2. Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening
3. Known allergy/sensitivity to tenofovir or emtricitabine
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
15 Years
Maximum Age:
19 Years
Study:
NCT03745495
Study Brief:
Protocol Section:
NCT03745495