HPTN 091
Status:
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
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
DescriptionExperimental: 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 DeliveryTablet
ARMsExperimental
Official Code:
NCT04742491
Trial Sponsors:
Gilead, HPTN
Start Date
End Date
March 21, 2021
November 30, 2024
Enrollment:0
Age range:
↔
any
Population:Cisgender Men