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Phase
Open Label
Principal Investigator(s)
Tonia Poteat
Objective
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.
Last updated June 10, 2022
Prevention Option(s)
PrEP
Observational
Prospective Cohort
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Experimental: Immediate Intervention Arm Descovy in the US
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
Mode of Delivery
Tablet
Products
TAF/FTC (Descovy)
ARMs
Experimental
Description
Experimental: Deferred Intervention Arm Descovy in the US
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
Mode of Delivery
Tablet
Products
TAF/FTC (Descovy)
ARMs
Experimental
Description
Experimental: Immediate Intervention Arm Truvada in Brazil
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
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Experimental: Deferred Intervention Arm Truvada in Brazil
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
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Experimental: Immediate Intervention Arm Truvada in the US
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
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Experimental: Deferred Intervention Arm Truvada in the US
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
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Trial Sponsors
HPTN, Gilead
March 2021
November 2024
Population
Men
Sites
Bridge HIV CRS
San Francisco, California
United States of America
Harlem Prevention Center
New York, NY
United States of America
Penn Prevention CRS
Philadelphia, Pennsylvania
United States of America
Houston AIDS Research Team CRS
Houston, Texas
United States of America
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro
Brazil