N/A
N=392
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
HIV Prevention
Bottom Line
View on ClinicalTrials.gov: NCT04114955 ↗Enrolled (actual)
392
Serious AEs
2.0%
Results posted
Feb 2026
Primary outcome: Primary: Changes in HIV Testing — 102; 100; 87; 83 Participants — p=0.484
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manas por Manas (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in HIV Testing |
102; 100; 87; 83; 8; 11 | 0.484 |
| PRIMARY Changes in PrEP Uptake |
10; 5; 150; 143; 0; 0 | 0.096 |
| PRIMARY Changes in PrEP Persistence |
27; 35; 16; 10; 19; 19 | 0.580 |
| SECONDARY Changes in PrEP Adherence |
5; 8; 4; 2; 9; 7 | 0.62 |
| SECONDARY Changes in Condom Use |
63; 69; 87; 77; 1; 3 | 0.24 |
| SECONDARY Changes in Utilization of Sexual Health Services |
17; 23; 171; 157; 18; 19 | 0.41 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04114955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.