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Gender-Affirmative Medical Care to Improve HIV Treatment Cascade Among Transgender Women
NCT03757117Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2016
- Primary completion
- Mar 2018
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 4, open-label, single-arm trial of estradiol valerate and spironolactone in human immunodeficiency virus type 1 infection (HIV-1), sponsored by Asociación Civil Impacta Salud y Educación. Primary endpoints: HIV viral suppression at 12 months and Knowledge of HIV serostatus at 12 months. Started Oct 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Intervention
Feminizing hormone therapy and peer navigation integrated with HIV care.
03
Who it enrols
Transgender women (assigned male at birth) aged 18 or older, residing in Lima, who are unaware of their HIV status or living with HIV but not engaged in care. Exclusion criteria include active tuberculosis, history of pancreatitis, and medical contraindications to hormone therapy.
04
Endpoints
Primary
HIV viral suppression
Knowledge of HIV serostatus
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