HIV Prevention
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Changes in HIV Testing | Every 3 months through study completion, up to 12 months | Self- and clinic-based HIV testing |
| Changes in PrEP Uptake | Every 3 months through study completion, up to 12 months | Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription |
| Changes in PrEP Persistence | Every 3 months through study completion, up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PrEP Adherence | Every 3 months through study completion, up to 12 months | Drug levels in dried blood spots sufficient for protection against HIV acquisition (\>=800 TFV/FTC fmol/punch) |
| Changes in Condom Use | Every 3 months through study completion, up to 12 months | Self-reported consistent condom use with regular and occasional partners and clients |
| Changes in Utilization of Sexual Health Services | Every 3 months through study completion, up to 12 months | Self-reported and clinic-based receipt of STI care referral |
Countries
Brazil
Contacts
University of California, San Francisco; Columbia University
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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 198 | 3 / 194 |
| other Total, other adverse events | 0 / 198 | 0 / 194 |
| serious Total, serious adverse events | 1 / 198 | 7 / 194 |