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

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ClinicalTrials.gov Identifier: NCT04114955
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Santa Casa Medical School
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV Prevention Behavioral: Manas por Manas Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: 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.
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.

Wait-list control
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.




Primary Outcome Measures :
  1. Changes in HIV testing [ Time Frame: Every 3 months through study completion, up to 12 months ]
    Self- and clinic-based HIV testing

  2. Changes in PrEP uptake [ Time Frame: Every 3 months through study completion, up to 12 months ]
    Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription

  3. Changes in PrEP persistence [ Time Frame: 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 Outcome Measures :
  1. Changes in PrEP adherence [ Time Frame: Every 3 months through study completion, up to 12 months ]
    Drug levels; Dried blood spots

  2. Changes in condom use [ Time Frame: Every 3 months through study completion, up to 12 months ]
    Self-reported consistent condom use with regular and occasional partners and clients

  3. Changes in utilization of sexual health services [ Time Frame: Every 3 months through study completion, up to 12 months ]
    Clinical data extraction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Assigned 'male' at birth but currently identify as female, transgender, transsexual, or travesti (a common term for trans women in Brazil)
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114955


Contacts
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Contact: Gustavo Saggese, PhD 4154766358 Gustavo.Saggese@ucsf.edu

Locations
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Brazil
CRT - Centro de Referência e Treinamento DST/AIDS Recruiting
São Paulo, Brazil
Contact: Ricardo Barbosa Martins, PhD    +5511 99904-1491    ricardo.martins@crt.saude.sp.gov.br   
Principal Investigator: Maria Amelia Veras, MD, PhD         
SAE - Serviço de Assistência Especializada Campos Elíseos Recruiting
São Paulo, Brazil
Contact: Thiago Pestana Pinto, MPH    +5511 95273-4093    thiago_pestana@yahoo.com.br   
Principal Investigator: Maria Amelia Veras, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Mental Health (NIMH)
Santa Casa Medical School
Investigators
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Principal Investigator: Jae Sevelius, PhD University of California, San Francisco
Principal Investigator: Sheri Lippman, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04114955    
Other Study ID Numbers: R01MH121308 ( U.S. NIH Grant/Contract )
R01MH121308 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
transgender women
HIV prevention
HIV testing
pre-exposure prophylaxis
Brazil