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

NCT04114955 | Completed Results DMC

• 1 other identifier: R01MH121308
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Prevention

Keywords

transgender women; HIV prevention; HIV testing; pre-exposure prophylaxis; Brazil

Outcome Measures

Primary Outcomes (3)

• Changes in HIV Testing

  Self- and clinic-based HIV testing

  Every 3 months through study completion, up to 12 months

• Changes in PrEP Uptake

  Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription

  Every 3 months through study completion, up to 12 months

• Changes in PrEP Persistence

  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

  Every 3 months through study completion, up to 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Wait-list control

OTHER

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

Behavioral: Manas por Manas

Interventions

Manas por Manas BEHAVIORAL

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.

Intervention; Wait-list control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Assigned 'male' at birth but currently identify as female, transgender, transsexual, or travesti (a common term for trans women in Brazil)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of California, San Francisco: lead
• Columbia University: collaborator
• Santa Casa Medical School: collaborator

Study Sites (2)

CRT - Centro de Referência e Treinamento DST/AIDS

São Paulo, Brazil

Location

SAE - Serviço de Assistência Especializada Campos Elíseos

São Paulo, Brazil

Location

Results Point of Contact

• Title: Dr. Sheri A Lippman
• Organization: University of California, San Francisco

sheri.lippman@ucsf.edu

4154762300

Study Officials

• Jae Sevelius, PhD

  University of California, San Francisco; Columbia University

  PRINCIPAL INVESTIGATOR

• Sheri Lippman, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 3, 2019
• Study Start: December 1, 2020
• Primary Completion: July 3, 2024
• Study Completion: October 3, 2024
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)