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

Study Overview
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Brief Summary
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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.

Detailed Description
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entered elsewhere

Official Title
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HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study

Conditions
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HIV Prevention

Intervention / Treatment
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* Drug: Immediate Intervention Arm Truvada in the US
* Drug: Deferred Intervention Arm Truvada in the US
* Drug: Immediate Intervention Arm Truvada in Brazil
* Drug: Deferred Intervention Arm Truvada in Brazil
* Drug: Immediate Intervention Arm Descovy in the US
* Drug: Deferred Intervention Arm Descovy in the US


Participation Criteria
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Eligibility Criteria
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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: 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. Willing to undergo all required study procedures. General good health, as evidenced by the following laboratory values: 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. 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: 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Intermediate Intervention Arm vs Deferred Intervention Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Arm Descovy in the US<br>PrEP provision, STI screening and treatment, gender affirming hormonal therapy, peer-health management using strengths-based management using Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) one tablet daily in the US | Drug: Immediate Intervention Arm Descovy in the US<br>* Descovy in the United States<br>* Other names: Descovy;|
| Experimental: Deferred Intervention Arm Descovy in the US<br>0-6 months PrEP provision, STI screening and treatment. From months 6-18 gender affirming hormonal therapy, peer-health management using strengths-based management using Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) one tablet daily in the US | Drug: Deferred Intervention Arm Descovy in the US<br>* Descovy in the United States<br>* Other names: Descovy;|
| Experimental: Immediate Intervention Arm Truvada in Brazil<br>PrEP provision, STI screening and treatment, gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in Brazil | Drug: Immediate Intervention Arm Truvada in Brazil<br>* Truvada in Brazil<br>* Other names: Truvada;|
| Experimental: Deferred Intervention Arm Truvada in Brazil<br>0-6 months PrEP provision, STI screening and treatment. From months 6-18 gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in Brazil | Drug: Deferred Intervention Arm Truvada in Brazil<br>* Truvada in Brazil<br>* Other names: Truvada;|
| Experimental: Immediate Intervention Arm Truvada in the US<br>PrEP provision, STI screening and treatment, gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in the US | Drug: Immediate Intervention Arm Truvada in the US<br>* Truvada in the United States<br>* Other names: Truvada;|
| Experimental: Deferred Intervention Arm Truvada in the US<br>0-6 months PrEP provision, STI screening and treatment. From months 6-18 gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in the US | Drug: Deferred Intervention Arm Truvada in the US<br>* Truvada in the United States<br>* Other names: Truvada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of hormonal therapy and PrEP | Strengths-based case management to measure amount of PrEP uptake and gender affirming hormonal therapy uptake | 0-36 months | 
| PrEP adherence and persistence | Measure of amount of drug taken via self reported pill count and biological markers via plasma | 0-36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence | Measured via 4th generation ELISA | 0-36 months | 
| STI incidence | GC/chlamydial and syphilis laboratory testing | 0-36 months | 
| Changes in sexual risk taking behavior | Self report number of partners, serostatus and number/type of acts | 0-36 months | 
| Measure of baseline lab data for suitability of this population for future PrEP research | Hepatitis B status via antibody, antigen and core antibody testing | 0-36 months | 
| Measure of baseline lab data for suitability of this population for future PrEP research | Hepatitis C testing via antibody testing | 0-36 months | 
| Measure of baseline lab data for suitability of this population for future PrEP research | serum creatinine | 0-36 months | 
| Measure of baseline lab data for suitability of this population for future PrEP research | urine for STI testing | 0-36 months | 
| Measure of baseline lab data for suitability of this population for future PrEP research | NAAT for rectal and pharyngeal swabs for STI testing | 0-36 months | 
| psychological factors tied to PreP uptake, adherence, persistence, interest in future HIV research | Self-administered questionnaire; o Depression via PHQ2: Scale 0-6, score 3 or higher is positive | 0-36 months | 
| behavioral alcohol use factors tied to PreP uptake, adherence, persistence, interest in future HIV research | Self-administered questionnaire; o Alcohol use via AUDIT-C: Scale 0-12 points. Score > 4 is positive | 0-36 months | 
| behavioral substance use factors tied to PreP uptake, adherence, persistence, interest in future HIV research | Self-administered questionnaire; o Substance use via CAGE-AID: Scale 0-4. Score >2 is positive. | 0-36 months | 
| PrEP uptake, adherence, persistence and interest in future HIV research | Self-administered questionnaire (no scale) | 0-36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender women, TGW