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

NCT04114955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2026-02-25

Study results available
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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.

Conditions

  • HIV Prevention

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jae Sevelius, PhD · University of California, San Francisco; Columbia University

  • Sheri Lippman, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-07-03
Completion
2024-10-03

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114955 on ClinicalTrials.gov