Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing a… (NCT04114955) | Clinical Trial Compass
CompletedNot Applicable
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Brazil392 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in HIV Testing
Timeframe: Every 3 months through study completion, up to 12 months
2
Changes in PrEP Uptake
Timeframe: Every 3 months through study completion, up to 12 months
3
Changes in PrEP Persistence
Timeframe: Every 3 months through study completion, up to 12 months