Status:
UNKNOWN
The BeT Study Intervention to Reduce Disparities in HIV Prevention and Care
Lead Sponsor:
Evandro Chagas National Institute of Infectious Disease
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
AIDS and Infections
HIV Prevention
Eligibility:
MALE
18-24 years
Phase:
NA
Brief Summary
Stigma prevents young transgender women from having access to HIV prevention and care services, despite the fact that these services are freely accessible to all Brazilians in the Unified Health Syste...
Detailed Description
Transvestites and young transsexual women in Brazil are exposed to a high risk of exposure to HIV and poor treatment of HIV infection. Brazil remains classified as a middle-income country in 2017 \[1\...
Eligibility Criteria
Inclusion
- Intervention study:
- Provision of signed and dated informed consent form
- Declaration of willingness to comply with all study procedures and availability during the study
- Age between 18 and 24 years
- Male sex designated at birth and self-reported gender identity as a transvestite, transsexual woman or other than the designated sex
- Desire to join the BeT intervention
- Access to a cell phone compatible with social networks (smartphone) to participate in a technology-based intervention
- Living in Rio de Janeiro or metropolitan area
- Potential participants living with HIV must meet the following criteria:
- Documented diagnosis of HIV infection
- No current use of HAART OR detectable CV result OR not being followed up at a health service OR having missed at least one appointment in the last six months.
- Potential HIV-negative participants must meet the following criteria:
- No current use of PrEP
- With indication of PrEP
- No contraindication to PrEP
- Intervention (pilot + expansion): 1) impossibility of consenting or not consenting to the research, 2) female sex assigned at birth, 3) self-identification other than transvestite, transgender woman or gender identity different from the male received at birth, 4) age under 18 or over 24 years old, 5) speak only a language other than Portuguese, 6) live outside the metropolitan region of Rio de Janeiro, 7) not have a cell phone, 8) not be sexually active.
- For HIV-negative volunteers, additional criteria are:
- 1\) being on PrEP. For HIV-positive volunteers, 1) having been diagnosed with HIV for more than one year, 2) being on regular antiretroviral therapy OR having an undetectable viral load (self-report), 3) being linked to a health service OR having attended to all consultations in the last six months.
- Additionally, for the expansion phase, the following will also be considered: participation in another intervention study to promote HIV prevention or care in the last year or concomitant participation in another study that prevents concomitant inclusion (co-enrollment), refusal to perform testing for HIV, and any health condition that, in the opinion of the investigator, precludes participation in the study or harms a potential participant.
Exclusion
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05299645
Start Date
February 1 2019
End Date
January 30 2023
Last Update
March 29 2022
Active Locations (1)
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1
Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360