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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH121308 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Santa Casa Medical School | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| Columbia University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
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| Wait-list control | Other | Control participants will receive the intervention after a one-year waiting period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manas por Manas | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HIV Testing | Self- and clinic-based HIV testing | Every 3 months through study completion, up to 12 months |
| Changes in PrEP Uptake | Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription | Every 3 months through study completion, up to 12 months |
| 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 | Every 3 months through study completion, up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PrEP Adherence | Drug levels in dried blood spots sufficient for protection against HIV acquisition (>=800 TFV/FTC fmol/punch) | Every 3 months through study completion, up to 12 months |
| Changes in Condom Use |
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Inclusion Criteria:
Exclusion Criteria:
Assigned 'male' at birth but currently identify as female, transgender, transsexual, or travesti (a common term for trans women in Brazil)
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| Name | Affiliation | Role |
|---|---|---|
| Jae Sevelius, PhD | University of California, San Francisco; Columbia University | Principal Investigator |
| Sheri Lippman, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRT - Centro de Referência e Treinamento DST/AIDS | São Paulo | Brazil | ||||
| SAE - Serviço de Assistência Especializada Campos ElÃseos |
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392 Randomized on day of enrollment
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention | Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study |
| FG001 | Delayed Intervention | Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention | Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study |
| BG001 | Delayed Intervention | Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age (categorical) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in HIV Testing | Self- and clinic-based HIV testing | 1 participant died prior to accruing any follow up data. Most participants contributed 4 intervals; participants newly diagnosed with HIV and participants who passed away during the study contributed fewer. | Posted | Count of Participants | Participants | Every 3 months through study completion, up to 12 months |
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2 years
All-Cause Mortality: Clinicaltrials.gov definition.
Serious Adverse Events: Clinicaltrials.gov definition. Note that we have included HIV seroconversion as HIV can be life-threatening if not properly treated and it does require medical intervention.
Other (Not Including Serious) Adverse Events: Clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Intervention | Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| First positive test for Human Immunodeficiency Virus | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheri A Lippman | University of California, San Francisco | 4154762300 | sheri.lippman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2019 | Dec 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2022 | Jul 31, 2025 | ICF_000.pdf |
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Self-reported consistent condom use with regular and occasional partners and clients
| Every 3 months through study completion, up to 12 months |
| Changes in Utilization of Sexual Health Services | Self-reported and clinic-based receipt of STI care referral | Every 3 months through study completion, up to 12 months |
| São Paulo |
| Brazil |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race, custom categories | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Sex work past 30 days | Earned income from sex work in the 30 days prior to enrollment | Count of Participants | Participants |
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| Housing status | Count of Participants | Participants |
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| HIV test in prior 12 months | Self-report of testing for HIV at a clinic or through a community-based organization at least once in past 12 months | Count of Participants | Participants |
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| Prior use of PrEP | Count of Participants | Participants |
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| Primary | Changes in PrEP Uptake | Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription | Ineligible individuals include:
Participant intervals are censored after PrEP initiation or on loss to follow up, as tabulated below. | Posted | Count of Participants | Participants | Every 3 months through study completion, up to 12 months |
|
|
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| Primary | 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 | Individuals on PrEP at start of each interval | Posted | Count of Participants | Participants | Every 3 months through study completion, up to 12 months |
|
|
|
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| Secondary | Changes in PrEP Adherence | Drug levels in dried blood spots sufficient for protection against HIV acquisition (>=800 TFV/FTC fmol/punch) | Participants contributed data for intervals in which they reported current PrEP use and presented to have a dried blood spot taken. | Posted | Count of Participants | Participants | Every 3 months through study completion, up to 12 months |
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| Secondary | Changes in Condom Use | Self-reported consistent condom use with regular and occasional partners and clients | 12 participants did not complete a follow-up visit during Year 1; 32 participants had no reported sex partners during Year 1 and were excluded from the analysis. | Posted | Count of Participants | Participants | Every 3 months through study completion, up to 12 months |
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| Secondary | Changes in Utilization of Sexual Health Services | Self-reported and clinic-based receipt of STI care referral | 1 participant died prior to completing on follow-up data; 9 additional participants contributed no follow-up data in Year 1. | Posted | Count of Participants | Participants | Every 3 months through study completion, up to 12 months |
|
|
|
|
| 1 |
| 198 |
| 1 |
| 198 |
| 0 |
| 198 |
| EG001 | Delayed Intervention | Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study | 3 | 194 | 7 | 194 | 0 | 194 |
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| Not tested |
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| Missing |
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| Not tested |
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| Missing |
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| Not tested |
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| Missing |
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| Did not initiate PrEP |
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| Lost to follow up |
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| Interval 2: 3-6 months |
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| Interval 3: 6-9 months |
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| Interval 4: 9-12 months |
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| No persistence |
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| Interval 2: 3-6 months |
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| Interval 3: 6-9 months |
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| Interval 4: 9-12 months |
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| Insufficient PrEP level |
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| Interval 2: 3-6 months |
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| Interval 3: 6-9 months |
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| Interval 4: 9-12 months |
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| No consistent condom use |
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| Missing |
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| Interval 2: 3-6 months |
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| Interval 3: 6-9 months |
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| Interval 4: 9-12 months |
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| Did not receive referral for STI services |
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| Interval 2: 3-6 months |
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| Interval 3: 6-9 months |
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| Interval 4: 9-12 months |
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