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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04114955
Acronym
PRISM Brazil
Enrollment
392
Registered
2019-10-03
Start date
2020-12-01
Completion date
2024-10-03
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Keywords

transgender women, HIV prevention, HIV testing, pre-exposure prophylaxis, Brazil

Brief 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.

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.

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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Santa Casa Medical School
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Columbia University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in HIV TestingEvery 3 months through study completion, up to 12 monthsSelf- and clinic-based HIV testing
Changes in PrEP UptakeEvery 3 months through study completion, up to 12 monthsInitiation of pre-exposure prophylaxis, measured as first filled PrEP prescription
Changes in PrEP PersistenceEvery 3 months through study completion, up to 12 monthsPersistence of pre-exposure prophylaxis, measured as sufficient pill dispensation for complete 3-month coverage with no more than 10 days uncovered in the period

Secondary

MeasureTime frameDescription
Changes in PrEP AdherenceEvery 3 months through study completion, up to 12 monthsDrug levels in dried blood spots sufficient for protection against HIV acquisition (\>=800 TFV/FTC fmol/punch)
Changes in Condom UseEvery 3 months through study completion, up to 12 monthsSelf-reported consistent condom use with regular and occasional partners and clients
Changes in Utilization of Sexual Health ServicesEvery 3 months through study completion, up to 12 monthsSelf-reported and clinic-based receipt of STI care referral

Countries

Brazil

Contacts

PRINCIPAL_INVESTIGATORJae Sevelius, PhD

University of California, San Francisco; Columbia University

PRINCIPAL_INVESTIGATORSheri Lippman, PhD

University of California, San Francisco

Participant flow

Recruitment details

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

Pre-assignment details

392 Randomized on day of enrollment

Baseline characteristics

Characteristic
Age, Customized
Age
18-29 years
75 Participants
Age, Customized
Age
30-39 years
124 Participants
Age, Customized
Age
40-49 years
82 Participants
Age, Customized
Age
50 years and over
21 Participants
Education
Incomplete secondary
96 Participants
Education
Primary or less
31 Participants
Education
Secondary or more
234 Participants
HIV test in prior 12 months
No
106 Participants
HIV test in prior 12 months
Yes
286 Participants
Housing status
Stable housing
288 Participants
Housing status
Unstable housing
52 Participants
Marital status
In a relationship
42 Participants
Marital status
Married or living with partner
61 Participants
Marital status
Single
289 Participants
Prior use of PrEP
No
135 Participants
Prior use of PrEP
Yes
59 Participants
Race/Ethnicity, Customized
Race
Black
52 Participants
Race/Ethnicity, Customized
Race
Indigenous, Asian, or Other
7 Participants
Race/Ethnicity, Customized
Race
More than 1 race
87 Participants
Race/Ethnicity, Customized
Race
White
52 Participants
Sex: Female, Male
Female
194 Participants
Sex: Female, Male
Male
0 Participants
Sex work past 30 days
No
121 Participants
Sex work past 30 days
Yes
76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1983 / 194
other
Total, other adverse events
0 / 1980 / 194
serious
Total, serious adverse events
1 / 1987 / 194

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026