Clinical trial NCT04114955: Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Official title: Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: transgender women
HIV prevention
HIV testing
pre-exposure prophylaxis
Brazil
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Santa Casa Medical School
name: National Institute of Mental Health (NIMH)
name: Columbia University
First posted: 2019-10-03
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in HIV testing
timeFrame: Every 3 months through study completion, up to 12 months
measure: Changes in PrEP uptake
timeFrame: Every 3 months through study completion, up to 12 months
measure: Changes in PrEP persistence
timeFrame: Every 3 months through study completion, up to 12 months
Secondary outcomes:
measure: Changes in PrEP adherence
timeFrame: Every 3 months through study completion, up to 12 months
measure: Changes in condom use
timeFrame: Every 3 months through study completion, up to 12 months
measure: Changes in utilization of sexual health services
timeFrame: Every 3 months through study completion, up to 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: CRT - Centro de Referência e Treinamento DST/AIDS
city: São Paulo
country: Brazil
facility: SAE - Serviço de Assistência Especializada Campos Elíseos
Study officials:
affiliation: University of California, San Francisco; Columbia University
name: Jae Sevelius, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sheri Lippman, PhD
role: PRINCIPAL_INVESTIGATOR
References: