Pre-Exposure Prophylaxis for Transgender Women in the US and South America
Summary
A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision. Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.
Timeline
- Start
- 2021-03-26
- Primary completion
- 2024-08-16
- Completion
- 2024-08-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Tenofovir | Small molecule | 200 mg | Oral |
| Background | Tenofovir | Small molecule | 300 mg | Oral |
| Background | tenofovir alafenamide | Small molecule | 25 mg | Oral |
| Background | tenofovir alafenamide | Small molecule | 200 mg | Oral |
Indications
No indication recorded.