The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community

Exclusion Criteria

• •Individuals with any of the following will be excluded:
• •* confirmed HIV infection by laboratory testing
• •* clinical symptoms consistent with possible acute HIV infection \[fatigue, fever, rash, night sweats, and adenopathy\];
• •* underlying bone disease (osteopenia or osteoporosis)
• •* Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid)
• •* No prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity.
• •* Unwilling to attend quarterly follow-up visits, which will include risk reduction/adherence counseling and repeat laboratory testing
• •* Has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives.