CClinicalTrials.gg
CompletedNCT04114955PRISM BrazilUpdated Feb 25, 2026Results posted

Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP

An interventional study of Manas por Manas in HIV Prevention, sponsored by University of California, San Francisco. Completed at 2 sites in Brazil. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
392
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil. The intervention will be evaluated using a randomized wait-list controlled trial to compare uptake of HIV testing (self-testing and clinic-based) (Aim 1), PrEP initiation and persistence (Aim 2), and other prevention services (e.g. harm reduction) among trans women in the intervention arm compared to those in the control arm with data collection scheduled every three-months. Investigators will assess changes in intersectional stigma (Aim 3), including reductions in internalized stigma and increased resilience to anticipated and enacted stigma, among those assigned to intervention compared to those assigned to the control arm, and assess how changes in stigma result in prevention uptake.

Read the detailed description

Globally, transgender ('trans') women experience extreme social and economic marginalization due to intersectional stigma, defined as the confluence of stigma that results from the intersection of social identities and positions among those who are multiply oppressed. Among trans women, gender-based stigma intersects with social positions such as engagement in sex work and substance use, generating a social context of vulnerability and increased risk of HIV acquisition. In Brazil, trans women are the 'most-at-risk' group for HIV, with 55 times higher estimated odds of HIV infection than the general population; further, uptake of HIV testing and pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups, despite availability in the public sector and documented interest in the community. Through extensive formative work, the investigators have developed a suite of evidence-informed interventions and HIV prevention strategies, all of which have demonstrated feasibility and acceptability by trans women in Brazil, to address intersectional stigma and increase engagement of trans women in the HIV prevention continuum. We propose to test a multi-level intervention, 'Guerreiras' ('warrior women', as named by trans women participants in Brazil), comprised of two intervention components designed to address intersectional stigma: 1) a group-level, peer-led intervention and 2) an individual-level peer navigation program to increase uptake of HIV testing and PrEP. Guerreiras is informed by a trans-specific conceptual model, gender affirmation theory, that describes intersectional stigma faced by trans women and frames investigations of how intersectional stigma results in health disparities, providing a framework for the development and testing of interventions to address intersectional stigma among trans women. The study team will recruit trans women (N=400) from clinical sites, outreach events, and an ongoing observational cohort in São Paulo, Brazil. Guerreiras will be evaluated using a randomized wait-list controlled trial to compare uptake of HIV testing (self-testing and clinic-based) (Aim 1), PrEP initiation and persistence (Aim 2), and other prevention services (e.g. harm reduction) among trans women in the intervention arm compared to those in the control arm with data collection scheduled every three-months. Investigators will assess changes in intersectional stigma (Aim 3), including reductions in internalized stigma and increased resilience to anticipated and enacted stigma, among those assigned to intervention compared to those assigned to the control arm, and assess how changes in stigma result in prevention uptake. Outcomes will be monitored through the national medications dispensing system (PrEP initiation and persistence), through clinical records and self-report (HIV testing), and through comprehensive surveys (intersectional stigma). The proposed research leverages a productive multi-disciplinary HIV research partnership with extensive experience working with trans women in Brazil, multi-level intervention components, and a context where PrEP and HIV Self Tests are available publicly, providing an opportunity to evaluate and scale-up an HIV prevention initiative in a key health disparity population, while contributing to nascent research in intersectional stigma.

02

Conditions studied

  • HIV Prevention

Keywords

  • transgender women
  • HIV prevention
  • HIV testing
  • pre-exposure prophylaxis
  • Brazil
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years or older;
  • assigned 'male' at birth but currently identify as female, transgender, transsexual, or travesti (a common identity term among trans women in Brazil);
  • not be known to be HIV positive;
  • be a resident of the São Paulo area; and
  • consent to study procedures, including consent to review their clinical records.

Exclusion criteria

Exclusion Criteria:

  • currently psychotic, suicidal, or manic;
  • known to be HIV-positive at enrollment.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
392 participants (actual)

Study arms

  • Active comparator
    Intervention

    Intervention condition comprised of two components designed to address intersectional stigma: 1) a group-level, peer-led intervention and 2) an individual-level peer navigation program to increase uptake of HIV testing and PrEP.

    Behavioral: Manas por Manas

  • Other
    Wait-list control

    Control participants will receive the intervention after a one-year waiting period.

    Behavioral: Manas por Manas

Interventions

  • BehavioralManas por Manas

    Manas for Manas works at both the group- and individual-levels to increase self-care and reduce the negative health impacts of stigma, including: 1) a group-level, peer-led intervention, which first demonstrated efficacy with trans women in the US as 'Sheroes' and has been successfully adapted for Brazil, and 2) an individual-level peer navigation program.

06

What researchers measure

Primary outcomes

  1. Changes in HIV Testing

    Self- and clinic-based HIV testing

    Time frame: Every 3 months through study completion, up to 12 months

  2. Changes in PrEP Uptake

    Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription

    Time frame: Every 3 months through study completion, up to 12 months

  3. Changes in PrEP Persistence

    Persistence of pre-exposure prophylaxis, measured as sufficient pill dispensation for complete 3-month coverage with no more than 10 days uncovered in the period

    Time frame: Every 3 months through study completion, up to 12 months

Secondary outcomes

  1. Changes in PrEP Adherence

    Drug levels in dried blood spots sufficient for protection against HIV acquisition (\>=800 TFV/FTC fmol/punch)

    Time frame: Every 3 months through study completion, up to 12 months

  2. Changes in Condom Use

    Self-reported consistent condom use with regular and occasional partners and clients

    Time frame: Every 3 months through study completion, up to 12 months

  3. Changes in Utilization of Sexual Health Services

    Self-reported and clinic-based receipt of STI care referral

    Time frame: Every 3 months through study completion, up to 12 months

07

Results

Posted Feb 25, 2026

Participant flow

Participants assessed for eligibility (n=653) Ineligible (n=60): Living outside São Paulo (35); Less than 18 years of age (1); HIV+ (24) Declined (n=69): Too busy (n=33); Not interested (n=23); Objected to study protocol (n=8); Not emotionally stable (n=1); Moving from the city (n=4) Never scheduled or missed enrollment visit: 132

Participant flow — Overall Study
MilestoneImmediate InterventionDelayed Intervention
Started198194
Completed179178
Not completed1916

Outcome measures

PrimaryChanges in HIV Testing

Self- and clinic-based HIV testing

Time frame:
Every 3 months through study completion, up to 12 months
Reported as:
Count of participants · Participants
Changes in HIV Testing
ParticipantsImmediate InterventionDelayed Intervention
Interval 1: 0-3 months — Tested102100
Interval 1: 0-3 months — Not tested8783
Interval 1: 0-3 months — Missing811
Interval 2: 3-6 months — Tested102105
Interval 2: 3-6 months — Not tested7468
Interval 2: 3-6 months — Missing2119
Interval 3: 6-9 months — Tested8888
Interval 3: 6-9 months — Not tested9484
Interval 3: 6-9 months — Missing1418
Interval 4: 9-12 months — Tested100102
Interval 4: 9-12 months — Not tested7170
Interval 4: 9-12 months — Missing2518
Statistical analysis
  • Immediate Intervention vs Delayed Intervention · Logistic generalized estimating equation · p = 0.484 · Odds ratio (or): 0.91 · 95% CI 0.69 to 1.19Baseline covariates adjusted: age (3 cat.), race = Black, marital status = single, education = secondary +, sex work, housing, HIV test past 12 months
PrimaryChanges in PrEP Uptake

Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription

Time frame:
Every 3 months through study completion, up to 12 months
Reported as:
Count of participants · Participants
Changes in PrEP Uptake
ParticipantsImmediate InterventionDelayed Intervention
Interval 1: 0-3 months — Initiated PrEP105
Interval 1: 0-3 months — Did not initiate PrEP150143
Interval 1: 0-3 months — Lost to follow up00
Interval 2: 3-6 months — Initiated PrEP1412
Interval 2: 3-6 months — Did not initiate PrEP136129
Interval 2: 3-6 months — Lost to follow up02
Interval 3: 6-9 months — Initiated PrEP84
Interval 3: 6-9 months — Did not initiate PrEP127124
Interval 3: 6-9 months — Lost to follow up13
Interval 4: 9-12 months — Initiated PrEP52
Interval 4: 9-12 months — Did not initiate PrEP122122
Interval 4: 9-12 months — Lost to follow up00
Statistical analysis
  • Immediate Intervention vs Delayed Intervention · Logistic generalized estimating equation · p = 0.096 · Odds ratio (or): 1.61 · 95% CI 0.92 to 2.81Baseline covariates adjusted: age (3 categories), race = Black, marital status = single, education = secondary +, sex work, housing, past use of PrEP
PrimaryChanges in PrEP Persistence

Persistence of pre-exposure prophylaxis, measured as sufficient pill dispensation for complete 3-month coverage with no more than 10 days uncovered in the period

Time frame:
Every 3 months through study completion, up to 12 months
Reported as:
Count of participants · Participants
Changes in PrEP Persistence
ParticipantsImmediate InterventionDelayed Intervention
Interval 1: 0-3 months — PrEP persistence2735
Interval 1: 0-3 months — No persistence1610
Interval 2: 3-6 months — PrEP persistence1919
Interval 2: 3-6 months — No persistence3838
Interval 3: 6-9 months — PrEP persistence2321
Interval 3: 6-9 months — No persistence4240
Interval 4: 9-12 months — PrEP persistence1824
Interval 4: 9-12 months — No persistence5239
Statistical analysis
  • Immediate Intervention vs Delayed Intervention · Logistic generalized estimating equation · p = 0.580 · Odds ratio (or): 0.86 · 95% CI 0.50 to 1.47Baseline covariates adjusted: age (3 categories), race = Black, marital status = single, education = secondary +, sex work, housing, past use of PrEP
SecondaryChanges in PrEP Adherence

Drug levels in dried blood spots sufficient for protection against HIV acquisition (\>=800 TFV/FTC fmol/punch)

Time frame:
Every 3 months through study completion, up to 12 months
Reported as:
Count of participants · Participants
Changes in PrEP Adherence
ParticipantsImmediate InterventionDelayed Intervention
Interval 1: 0-3 months — Sufficient PrEP level58
Interval 1: 0-3 months — Insufficient PrEP level42
Interval 2: 3-6 months — Sufficient PrEP level97
Interval 2: 3-6 months — Insufficient PrEP level39
Interval 3: 6-9 months — Sufficient PrEP level910
Interval 3: 6-9 months — Insufficient PrEP level96
Interval 4: 9-12 months — Sufficient PrEP level119
Interval 4: 9-12 months — Insufficient PrEP level76
Statistical analysis
  • Immediate Intervention vs Delayed Intervention · Logistic generalized estimating equation · p = 0.62 (The a priori threshold for statistical significance was 0.05.) · Odds ratio (or): 1.38 · 95% CI 0.39 to 4.88
SecondaryChanges in Condom Use

Self-reported consistent condom use with regular and occasional partners and clients

Time frame:
Every 3 months through study completion, up to 12 months
Reported as:
Count of participants · Participants
Changes in Condom Use
ParticipantsImmediate InterventionDelayed Intervention
Interval 1: 0-3 months — Consistent condom use6369
Interval 1: 0-3 months — No consistent condom use8777
Interval 1: 0-3 months — Missing13
Interval 2: 3-6 months — Consistent condom use5968
Interval 2: 3-6 months — No consistent condom use8374
Interval 2: 3-6 months — Missing30
Interval 3: 6-9 months — Consistent condom use5764
Interval 3: 6-9 months — No consistent condom use8378
Interval 3: 6-9 months — Missing02
Interval 4: 9-12 months — Consistent condom use5672
Interval 4: 9-12 months — No consistent condom use8877
Interval 4: 9-12 months — Missing01
Statistical analysis
  • Immediate Intervention vs Delayed Intervention · Logistic generalized estimating equation · p = 0.24 (The a priori threshold for statistical significance was set at 0.05.) · Odds ratio (or): 0.81 · 95% CI 0.57 to 1.15Baseline covariates adjusted: age (3 cat.), race = Black, marital status = single, education = secondary +, sex work, housing = unstable
SecondaryChanges in Utilization of Sexual Health Services

Self-reported and clinic-based receipt of STI care referral

Time frame:
Every 3 months through study completion, up to 12 months
Reported as:
Count of participants · Participants
Changes in Utilization of Sexual Health Services
ParticipantsImmediate InterventionDelayed Intervention
Interval 1: 0-3 months — Received referral for STI services1723
Interval 1: 0-3 months — Did not receive referral for STI services171157
Interval 2: 3-6 months — Received referral for STI services1819
Interval 2: 3-6 months — Did not receive referral for STI services154151
Interval 3: 6-9 months — Received referral for STI services1720
Interval 3: 6-9 months — Did not receive referral for STI services162154
Interval 4: 9-12 months — Received referral for STI services2525
Interval 4: 9-12 months — Did not receive referral for STI services148150
Statistical analysis
  • Immediate Intervention vs Delayed Intervention · Logistic generalized estimating equation · p = 0.41 · Odds ratio (or): 0.86 · 95% CI 0.61 to 1.22

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Immediate Intervention1/198 (0.5%)1/198 (0.5%)0/198 (0%)
Delayed Intervention3/194 (1.5%)7/194 (3.6%)0/194 (0%)
Most frequent serious events
Most frequent serious events
EventImmediate InterventionDelayed Intervention
First positive test for Human Immunodeficiency VirusImmune system disorders1/1987/194

Baseline characteristics

Age, Customized
Age, Customized(Participants)Immediate InterventionDelayed InterventionTotal
Age — 18-29 years7590165
Age — 30-39 years7252124
Age — 40-49 years384482
Age — 50 years and over13821
Sex: Female, Male
Sex: Female, Male(Participants)Immediate InterventionDelayed InterventionTotal
Female198194392
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Immediate InterventionDelayed InterventionTotal
Race — Black524799
Race — White5255107
Race — More than 1 race8791178
Race — Indigenous, Asian, or Other718
Marital status
Marital status(Participants)Immediate InterventionDelayed InterventionTotal
Single142147289
In a relationship281442
Married or living with partner283361
Education
Education(Participants)Immediate InterventionDelayed InterventionTotal
Primary or less313162
Incomplete secondary494796
Secondary or more118116234
Sex work past 30 days
Sex work past 30 days(Participants)Immediate InterventionDelayed InterventionTotal
No122121243
Yes7673149
Housing status
Housing status(Participants)Immediate InterventionDelayed InterventionTotal
Stable housing146142288
Unstable housing5252104
HIV test in prior 12 months
HIV test in prior 12 months(Participants)Immediate InterventionDelayed InterventionTotal
No4957106
Yes149137286

1 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • CRT - Centro de Referência e Treinamento DST/AIDS
    São Paulo, Brazil
  • SAE - Serviço de Assistência Especializada Campos Elíseos
    São Paulo, Brazil
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 23, 2019
  • Informed consent form · Jul 14, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04114955
Lead sponsor
University of California, San Francisco
Collaborators
Santa Casa Medical School, National Institute of Mental Health (NIMH), Columbia University
Responsible party
Sponsor
First posted
Oct 3, 2019
Start date
Dec 1, 2020
Primary completion
Jul 3, 2024
Completion
Oct 3, 2024
Results posted
Feb 25, 2026
Last update
Feb 25, 2026

Study contacts

Jae Sevelius, PhD
principal investigator · University of California, San Francisco; Columbia University
Sheri Lippman, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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