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
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.
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.
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Exclusion Criteria:
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
Control participants will receive the intervention after a one-year waiting period.
Behavioral: Manas 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.
Changes in HIV Testing
Self- and clinic-based HIV testing
Time frame: 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
Time frame: 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
Time frame: Every 3 months through study completion, up to 12 months
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
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
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
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
| Milestone | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Started | 198 | 194 |
| Completed | 179 | 178 |
| Not completed | 19 | 16 |
Self- and clinic-based HIV testing
| Participants | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Interval 1: 0-3 months — Tested | 102 | 100 |
| Interval 1: 0-3 months — Not tested | 87 | 83 |
| Interval 1: 0-3 months — Missing | 8 | 11 |
| Interval 2: 3-6 months — Tested | 102 | 105 |
| Interval 2: 3-6 months — Not tested | 74 | 68 |
| Interval 2: 3-6 months — Missing | 21 | 19 |
| Interval 3: 6-9 months — Tested | 88 | 88 |
| Interval 3: 6-9 months — Not tested | 94 | 84 |
| Interval 3: 6-9 months — Missing | 14 | 18 |
| Interval 4: 9-12 months — Tested | 100 | 102 |
| Interval 4: 9-12 months — Not tested | 71 | 70 |
| Interval 4: 9-12 months — Missing | 25 | 18 |
Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription
| Participants | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Interval 1: 0-3 months — Initiated PrEP | 10 | 5 |
| Interval 1: 0-3 months — Did not initiate PrEP | 150 | 143 |
| Interval 1: 0-3 months — Lost to follow up | 0 | 0 |
| Interval 2: 3-6 months — Initiated PrEP | 14 | 12 |
| Interval 2: 3-6 months — Did not initiate PrEP | 136 | 129 |
| Interval 2: 3-6 months — Lost to follow up | 0 | 2 |
| Interval 3: 6-9 months — Initiated PrEP | 8 | 4 |
| Interval 3: 6-9 months — Did not initiate PrEP | 127 | 124 |
| Interval 3: 6-9 months — Lost to follow up | 1 | 3 |
| Interval 4: 9-12 months — Initiated PrEP | 5 | 2 |
| Interval 4: 9-12 months — Did not initiate PrEP | 122 | 122 |
| Interval 4: 9-12 months — Lost to follow up | 0 | 0 |
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
| Participants | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Interval 1: 0-3 months — PrEP persistence | 27 | 35 |
| Interval 1: 0-3 months — No persistence | 16 | 10 |
| Interval 2: 3-6 months — PrEP persistence | 19 | 19 |
| Interval 2: 3-6 months — No persistence | 38 | 38 |
| Interval 3: 6-9 months — PrEP persistence | 23 | 21 |
| Interval 3: 6-9 months — No persistence | 42 | 40 |
| Interval 4: 9-12 months — PrEP persistence | 18 | 24 |
| Interval 4: 9-12 months — No persistence | 52 | 39 |
Drug levels in dried blood spots sufficient for protection against HIV acquisition (\>=800 TFV/FTC fmol/punch)
| Participants | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Interval 1: 0-3 months — Sufficient PrEP level | 5 | 8 |
| Interval 1: 0-3 months — Insufficient PrEP level | 4 | 2 |
| Interval 2: 3-6 months — Sufficient PrEP level | 9 | 7 |
| Interval 2: 3-6 months — Insufficient PrEP level | 3 | 9 |
| Interval 3: 6-9 months — Sufficient PrEP level | 9 | 10 |
| Interval 3: 6-9 months — Insufficient PrEP level | 9 | 6 |
| Interval 4: 9-12 months — Sufficient PrEP level | 11 | 9 |
| Interval 4: 9-12 months — Insufficient PrEP level | 7 | 6 |
Self-reported consistent condom use with regular and occasional partners and clients
| Participants | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Interval 1: 0-3 months — Consistent condom use | 63 | 69 |
| Interval 1: 0-3 months — No consistent condom use | 87 | 77 |
| Interval 1: 0-3 months — Missing | 1 | 3 |
| Interval 2: 3-6 months — Consistent condom use | 59 | 68 |
| Interval 2: 3-6 months — No consistent condom use | 83 | 74 |
| Interval 2: 3-6 months — Missing | 3 | 0 |
| Interval 3: 6-9 months — Consistent condom use | 57 | 64 |
| Interval 3: 6-9 months — No consistent condom use | 83 | 78 |
| Interval 3: 6-9 months — Missing | 0 | 2 |
| Interval 4: 9-12 months — Consistent condom use | 56 | 72 |
| Interval 4: 9-12 months — No consistent condom use | 88 | 77 |
| Interval 4: 9-12 months — Missing | 0 | 1 |
Self-reported and clinic-based receipt of STI care referral
| Participants | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Interval 1: 0-3 months — Received referral for STI services | 17 | 23 |
| Interval 1: 0-3 months — Did not receive referral for STI services | 171 | 157 |
| Interval 2: 3-6 months — Received referral for STI services | 18 | 19 |
| Interval 2: 3-6 months — Did not receive referral for STI services | 154 | 151 |
| Interval 3: 6-9 months — Received referral for STI services | 17 | 20 |
| Interval 3: 6-9 months — Did not receive referral for STI services | 162 | 154 |
| Interval 4: 9-12 months — Received referral for STI services | 25 | 25 |
| Interval 4: 9-12 months — Did not receive referral for STI services | 148 | 150 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Intervention | 1/198 (0.5%) | 1/198 (0.5%) | 0/198 (0%) |
| Delayed Intervention | 3/194 (1.5%) | 7/194 (3.6%) | 0/194 (0%) |
| Event | Immediate Intervention | Delayed Intervention |
|---|---|---|
| First positive test for Human Immunodeficiency VirusImmune system disorders | 1/198 | 7/194 |
| Age, Customized(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Age — 18-29 years | 75 | 90 | 165 |
| Age — 30-39 years | 72 | 52 | 124 |
| Age — 40-49 years | 38 | 44 | 82 |
| Age — 50 years and over | 13 | 8 | 21 |
| Sex: Female, Male(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Female | 198 | 194 | 392 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Race — Black | 52 | 47 | 99 |
| Race — White | 52 | 55 | 107 |
| Race — More than 1 race | 87 | 91 | 178 |
| Race — Indigenous, Asian, or Other | 7 | 1 | 8 |
| Marital status(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Single | 142 | 147 | 289 |
| In a relationship | 28 | 14 | 42 |
| Married or living with partner | 28 | 33 | 61 |
| Education(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Primary or less | 31 | 31 | 62 |
| Incomplete secondary | 49 | 47 | 96 |
| Secondary or more | 118 | 116 | 234 |
| Sex work past 30 days(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| No | 122 | 121 | 243 |
| Yes | 76 | 73 | 149 |
| Housing status(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Stable housing | 146 | 142 | 288 |
| Unstable housing | 52 | 52 | 104 |
| HIV test in prior 12 months(Participants) | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| No | 49 | 57 | 106 |
| Yes | 149 | 137 | 286 |
1 further baseline measures are reported on the registry.
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