Summary

for males ages 18 years and up (full criteria)
healthy people welcome
study started
estimated completion
Jae Sevelius, PhDSheri Lippman, PhD

Description

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.

Details

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 HIVST 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.

Keywords

HIV Prevention transgender women HIV testing pre-exposure prophylaxis Brazil Guerreiras

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.

You CAN'T join if...

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

Lead Scientists

  • Jae Sevelius, PhD
    I am an Associate Professor in Residence with the Center for AIDS Prevention Studies (CAPS), Division of Prevention Sciences, Department of Medicine, at the University of California, San Francisco.
  • Sheri Lippman, PhD
    Associate Professor, Medicine. Authored (or co-authored) 80 research publications. Research interests: Community engagement/ community mobilization · Social intervention for HIV prevention · Multi-level intervention programs · Implementation science · International (public health) - South Africa / Brazil · Rapid self-testing and point-of-care testing for STI/HIV

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04114955
Study Type
Interventional
Last Updated