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

NCT04742491 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HPTN 091
• Study Type: interventional
• Target: 304
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

HIV Prevention

Keywords

Transgender women; TGW

Outcome Measures

Primary Outcomes (14)

• PrEP Uptake

  Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.

  0-18 months

• PrEP Adherence

  Self-reported adherence to daily PrEP by study visit

  0-18 months

• Acceptability and Feasibility of Co-located Services

  Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.

  0-18 months

• Participant Retention at Weeks 26, 52 and 78

  Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.

  Weeks 26, 52, 78

• Acceptability and Feasibility of Peer Health Navigation

  The average number of peer health navigator encounters.

  0-18 months

• Acceptability and Feasibility of Peer Health Navigation

  Number of each type of peer health navigation encounter.

  0-18 months

• Acceptability and Feasibility of Co-located Services

  Percentage of participants who report desire for co-located services at the end of the study

  0-18 months

• PrEP Adherence

  The average number of days to first PrEP permanent discontinuation.

  0-18 months

• PrEP Adherence

  The median number of days to first PrEP permanent discontinuation.

  0-18 months

• PrEP Adherence

  Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

  0-18 months

• PrEP Adherence

  Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

  0-18 months

• PrEP Adherence

  The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample.

  Week 26

• PrEP Persistent

  PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.

  0-18 months

• PrEP Uptake

  Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic..

  Week 26

Secondary Outcomes (18)

• Examining Changes in Sexual Risk-taking Behavior

  0-18 months

• Examining Changes in Sexual Risk-taking Behavior

  0-18 months

• Examining Changes in Sexual Risk-taking Behavior

  0-18 months

• Examining Changes in Sexual Risk-taking Behavior

  0-18 months

• Prevalence of STI Infection (GC, CT, Syphilis) at Baseline

  0 months

Study Arms (2)

Immediate Intervention Arm

EXPERIMENTAL

PrEP (pre-exposure prophylaxis) provision, STI screening and treatment, GAHT (gender-affirming hormonal therapy), peer-health management using strengths-based management. PrEP provision includes using one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil.

Drug: Immediate Intervention Arm

Deferred Intervention Arm

EXPERIMENTAL

0-6 months PrEP (pre-exposure prophylaxis) provision and STI screening and treatment. From months 6-18, GAHT (gender-affirming hormonal therapy) and peer-health management using strengths-based management. PrEP provision includes one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily table of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil.

Drug: Deferred Intervention Arm

Interventions

Immediate Intervention Arm DRUG

Truvada, Descovy in the United States; Truvada in Brazil

Also known as: Truvada, Descovy

Immediate Intervention Arm

Deferred Intervention Arm DRUG

Truvada, Descovy in the United States; Truvada in Brazil

Also known as: Truvada, Descovy

Deferred Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• Gilead Sciences: collaborator

Study Sites (5)

Bridge HIV CRS

San Francisco, California, 94102, United States

Location

Harlem Prevention Center CRS

New York, New York, 10027, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Houston AIDS Research Team CRS

Houston, Texas, 77030, United States

Location

Instituto de Pesquisa Clinicaq Evandro Chagas CRS

Manguinhos, Rio de Janeiro, 221045-900, Brazil

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; emtricitabine tenofovir alafenamide

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: HPTN Statistical Manager
• Organization: HPTN Statistical & Data Management Center

HPTN-Data-Access@scharp.org

206-667-4004

Study Officials

• Tonia Poteat, PhD, MPH

  UNC Chapel Hill

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Intermediate Intervention Arm vs. Deferred Intervention Arm

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: February 8, 2021
• Study Start: March 26, 2021
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); US (4)