Pre-Exposure Prophylaxis for Transgender Women in the US and South America (NCT04742491) | Clinical Trial Compass
CompletedPhase 2/3
Pre-Exposure Prophylaxis for Transgender Women in the US and South America
United States, Brazil304 participantsStarted 2021-03-26
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months.
✓. History of STI(s) in the past 6 months.
✓. Calculated creatinine clearance ≥ 60 mL/minute using the Cockcroft-Gault equation.
✓. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN.)
✓. HBV surface antigen (HBsAg) negative.
Exclusion criteria
✕. Any reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed.
✕. Plans to move away from the site area within the next 18 months.
✕. 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).
What they're measuring
1
PrEP Uptake
Timeframe: 0-18 months
2
PrEP Adherence
Timeframe: 0-18 months
3
Acceptability and Feasibility of Co-located Services
Timeframe: 0-18 months
4
Participant Retention at Weeks 26, 52 and 78
Timeframe: Weeks 26, 52, 78
5
Acceptability and Feasibility of Peer Health Navigation
Timeframe: 0-18 months
6
Acceptability and Feasibility of Peer Health Navigation
Timeframe: 0-18 months
7
Acceptability and Feasibility of Co-located Services
✕. 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).
✕. History of deep vein thrombosis, pulmonary embolism, and/or clotting disorder.
✕. 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.
✕. 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.