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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04077151
Eligibility Criteria:
Inclusion Criteria:
* Self-identification as a transgender individual \[As determined by the two-step process of gender identification whereby potential participants will be asked their gender identity and sex assigned at birth\]
* HIV-uninfected by EIA and viral load within 7 days of study entry
* Creatinine clearance ≥ 60 mL/min by Cockroft Gault for ages ≥18 years (Schwartz equation for those \<18)
* Willing to comply with all study procedures
* On a stable dose of cs-HT for at least 2 months verified by clinical chart review and willing to not change doses for duration of PK study
Exclusion Criteria:
* Hospitalization within 30 days of study entry (elective procedures okay with team approval)
* Condition (medical, psychological, or social) that, in the opinion of the study investigators, would preclude the participant from completing study-required procedures
* Previous participation in an HIV vaccine study, unless the participant can document placebo arm assignment
* Use of TDF/FTC in the past 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
24 Years
Study:
NCT04077151
Study Brief:
Protocol Section:
NCT04077151