Status:
COMPLETED
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development
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
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
- HIV uninfected
- Able to provide informed consent in English
- Self-reports HIV transmission risk behavior including one or more of the following: a) condomless anal or vaginal intercourse, b) 3 or more sexual partners in the past 3 months, c) any diagnosis by self-report of a STI in the past 12 months, and e) any history of transactional sex work
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 :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04077138
Start Date
January 1 2019
End Date
November 30 2023
Last Update
April 1 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado, Denver
Denver, Colorado, United States, 80045
2
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104