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临床试验/NCT04114955
NCT04114955
已完成
不适用

Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 392 人2020年12月1日
干预措施Manas por Manas

概览

阶段
不适用
干预措施
Manas por Manas
疾病 / 适应症
HIV Prevention
发起方
University of California, San Francisco
入组人数
392
试验地点
2
主要终点
Changes in HIV Testing
状态
已完成
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2020年12月1日
结束日期
2024年10月3日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
Male

研究者

入排标准

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Intervention

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.

干预措施: Manas por Manas

Wait-list control

Control participants will receive the intervention after a one-year waiting period.

干预措施: Manas por Manas

结局指标

主要结局

Changes in HIV Testing

时间窗: Every 3 months through study completion, up to 12 months

Self- and clinic-based HIV testing

Changes in PrEP Uptake

时间窗: 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

时间窗: 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

次要结局

  • Changes in PrEP Adherence(Every 3 months through study completion, up to 12 months)
  • Changes in Condom Use(Every 3 months through study completion, up to 12 months)
  • Changes in Utilization of Sexual Health Services(Every 3 months through study completion, up to 12 months)

研究点 (2)

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