Pre-Exposure Prophylaxis for Transgender Women in the US and South America

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.

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Eligibility Criteria:
Inclusion Criteria:

* TGW (assigned male at birth, trans-feminine spectrum - as defined in the SSP Manual - by self-report) who meet all of the following criteria are eligible for inclusion in this study.
* Eighteen years or older at the time of screening.
* Willing and able to provide informed consent for the study.
* Interest in PrEP - as defined in the SSP Manual.
* Non-reactive HIV test results at Screening and Enrollment.
* Available to return for all study visits and within site catchment area, as defined per site's Standard Operating Procedures (SOP).
* At risk for sexually acquiring HIV infection based on self-report of at least one of the following:

  1. Any anal or vaginal sex with one or more serodiscordant or HIV-unknown serostatus sexual partners in the previous 3 months, regardless of condom use.
  2. Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months.
  3. History of STI(s) in the past 6 months.
* Willing to undergo all required study procedures.
* General good health, as evidenced by the following laboratory values:

  1. Calculated creatinine clearance ≥ 60 mL/minute using the Cockcroft-Gault equation.
  2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN.)
  3. HBV surface antigen (HBsAg) negative.

Note: Otherwise eligible participants with laboratory results outside the above-mentioned values, with the exception of those with reactive HIV test, can be re-tested during the screening window. Participants with reactive HIV tests will not be able to rescreen.

Note: Participants who practice receptive vaginal sex cannot be provided Descovy® as it is not approved for this indication.

Exclusion Criteria:

1. Any reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed.
2. Plans to move away from the site area within the next 18 months.
3. Co-enrollment in any other research study that may interfere with this study (as provided by self-report or other available documentation). Exceptions may be made after consultation with the Clinical Management Committee (CMC).
4. Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy).
5. History of deep vein thrombosis, pulmonary embolism, and/or clotting disorder.
6. Active or planned use of medications with significant drug interactions as described in the Package Insert for Truvada® or Descovy®, per clinician's discretion (provided by selfreport or obtained from medical history or medical records). See Section 5.8 for a full list of drug interactions.
7. Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.