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HIV PreventionPhase 2/3NCT04742491

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

A Phase 2/3 study testing Immediate Intervention Arm and Deferred Intervention Arm in people with HIV Prevention, run by HIV Prevention Trials Network at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention
What is being tested?
Immediate Intervention Arm and Deferred Intervention Arm
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
5 sitesin 2 countries
Study dates
26 Mar 2021to 16 Aug 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • Harlem Prevention Center CRS

    New York, New York, 10027

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104

  • Bridge HIV CRS

    San Francisco, California, 94102

Other trials in United States

Brazil1 site

  • Instituto de Pesquisa Clinicaq Evandro Chagas CRS

    Manguinhos, Rio de Janeiro, 221045-900

Other trials in Brazil

About this study

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

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.

Read the detailed description

entered elsewhere

Conditions
HIV Prevention
Being tested
Immediate Intervention Arm, Deferred Intervention Arm
Keywords
Transgender women, TGW

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate Intervention ArmDrug

    Also called Truvada, Descovy

    Truvada, Descovy in the United States; Truvada in Brazil

  • Deferred Intervention ArmDrug

    Also called Truvada, Descovy

    Truvada, Descovy in the United States; Truvada in Brazil

Study groups in NCT04742491
Study groupRoleWhat they receive
Immediate Intervention ArmExperimentalPrEP (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.
Receives: Drug: Immediate Intervention Arm
Deferred Intervention ArmExperimental0-6 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.
Receives: Drug: Deferred Intervention Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP Uptake

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

    Measured: 0-18 months

  2. PrEP Adherence

    Self-reported adherence to daily PrEP by study visit

    Measured: 0-18 months

  3. Acceptability and Feasibility of Co-located Services

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

    Measured: 0-18 months

  4. 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.

    Measured: Weeks 26, 52, 78

  5. Acceptability and Feasibility of Peer Health Navigation

    The average number of peer health navigator encounters.

    Measured: 0-18 months

  6. Acceptability and Feasibility of Peer Health Navigation

    Number of each type of peer health navigation encounter.

    Measured: 0-18 months

  7. Acceptability and Feasibility of Co-located Services

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

    Measured: 0-18 months

  8. PrEP Adherence

    The average number of days to first PrEP permanent discontinuation.

    Measured: 0-18 months

  9. PrEP Adherence

    The median number of days to first PrEP permanent discontinuation.

    Measured: 0-18 months

  10. PrEP Adherence

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

    Measured: 0-18 months

  11. PrEP Adherence

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

    Measured: 0-18 months

  12. 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.

    Measured: Week 26

  13. 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.

    Measured: 0-18 months

  14. 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..

    Measured: Week 26

Secondary outcomes (18)

  1. Examining Changes in Sexual Risk-taking Behavior

    Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.

    Measured: 0-18 months

  2. Examining Changes in Sexual Risk-taking Behavior

    Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.

    Measured: 0-18 months

  3. Examining Changes in Sexual Risk-taking Behavior

    Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78.

    Measured: 0-18 months

  4. Examining Changes in Sexual Risk-taking Behavior

    Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78.

    Measured: 0-18 months

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

    To determine baseline prevalence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) by study arm

    Measured: 0 months

  6. Estimate Prevalence of Baseline Laboratory Values.

    To obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions.

    Measured: 0 months

  7. Gender-Affirming Hormone Therapy by Visit

    Taken hormones for gender identity/transition

    Measured: 0-18 months

  8. Gender-Affirming Hormone Therapy by Visit

    Currently taking hormones for gender identity/transition

    Measured: 0-18 months

  9. Gender-Affirming Hormone Therapy by Visit

    Where do you currently get your hormones?

    Measured: 0-18 months

  10. Gender-Affirming Hormone Therapy by Visit

    Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly

    Measured: 0-18 months

  11. Gender-Affirming Hormone Therapy by Visit

    Ever had breast augmentation/surgery

    Measured: 0-18 months

  12. Gender-Affirming Hormone Therapy by Visit

    Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS

    Measured: 0-18 months

  13. Annual Incidence of HIV Infections

    The number of incident HIV infections at each time point by arm.

    Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39.

    Measured: 0-18 months

  14. Incidence of STI Infection (GC, CT, Syphilis)

    To determine annual incidence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm.

    Measured: 0-18 months

  15. Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake

    PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.

    Measured: 0-18 months

  16. Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.

    The number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS):

    Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch

    Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits.

    Measured: 0-18 months

  17. Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence

    PrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS):

    Truvada: TFV-DP ≥ 900 fmol/punch

    Descovy: TFV-DP ≥ 950 fmol/punch

    PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table.

    Measured: 0-18 months

  18. Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research

    An overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table.

    Measured: 0-18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start26 Mar 2021
  3. Primary completion16 Aug 2024
  4. Study completion16 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intermediate Intervention Arm vs. Deferred Intervention Arm
Masking
None (open label)
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742491
Sponsor's protocol ID
HPTN 091
Status last verified
Dec 2025
First submitted
30 Nov 2020
Last updated
17 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Immediate Intervention Arm and Deferred Intervention Arm in people with HIV Prevention, run by HIV Prevention Trials Network at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP Uptake (time frame: 0-18 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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