Status:
COMPLETED
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project
Lead Sponsor:
Hektoen Institute for Medical Research
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV/AIDS
Gender
Eligibility:
All Genders
15-24 years
Phase:
NA
Brief Summary
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integ...
Detailed Description
Transgender women (TW) are one of the most vulnerable populations for acquiring HIV infection, and the scant available data on transgender men (TM) suggests they are also at risk. TW have accounted fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04077151
Start Date
March 14 2022
End Date
November 30 2023
Last Update
April 2 2024
Active Locations (1)
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1
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612