The BeT Study Intervention to Reduce Disparities in HIV Prevention and Care

NCT05299645 | Unknown DMC

• 2 other identifiers: 050188180000052625UG3HD096914
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 System (ie, SUS). Levels of HIV testing and access to care for young people are uneven. The purpose of this proposal is to generate data to address stigma in the public health system and intervene to overcome the challenges of youth with the navigation of health systems. The Brilhar e Transcender (BeT) study will include young trans women, aged 18 to 24, in Rio de Janeiro, Brazil. The BeT intervention has been found to be preliminarily efficacious in a pilot study. This proposal is for a study to test the effectiveness of an intervention to improve HIV prevention and care engagement among young trans women (N=150) at risk of HIV in Brazil.

Conditions

AIDS and Infections; HIV Prevention; Stigma, Social; Hiv

Keywords

Transvestites; Transsexual women; Assistance; Prevention

Outcome Measures

Primary Outcomes (1)

• Engagment on HIV prevention or care (for trans women)

  Data from these surveys will be used to verify the primary outcomes of HIV testing, PrEP adoption, and attachment to HIV care. The results of this proposal could determine the preliminary effectiveness of the intervention in ensuring that trans youth undergo frequent HIV testing, engage in PrEP use and in HIV care.

  10 months

Study Arms (1)

Arm 1 - Transvestites and young transsexual women

EXPERIMENTAL

Qualitative interviews

Behavioral: Interview

Interventions

Interview BEHAVIORAL

Pilot study with digital browsers

Also known as: Queries

Arm 1 - Transvestites and young transsexual women

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: transvestites and young transsexual women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Intervention study: 1. Provision of signed and dated informed consent form 2. Declaration of willingness to comply with all study procedures and availability during the study 3. Age between 18 and 24 years 4. Male sex designated at birth and self-reported gender identity as a transvestite, transsexual woman or other than the designated sex 5. Desire to join the BeT intervention 6. Access to a cell phone compatible with social networks (smartphone) to participate in a technology-based intervention 7. Living in Rio de Janeiro or metropolitan area Potential participants living with HIV must meet the following criteria: 1. Documented diagnosis of HIV infection 2. 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: 1. No current use of PrEP 2. With indication of PrEP 3. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Evandro Chagas National Institute of Infectious Disease: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

RECRUITING

Related Publications (1)

• Jalil EM, Wilson E, Monteiro L, Varggas T, Moura I, Torres TS, Hoagland B, Cardoso SW, Ismerio Moreira R, Goncalves Veloso Dos Santos V, Grinsztejn B; BeT Team. A Peer-Led Digital Intervention to Reduce HIV Prevention and Care Disparities Among Young Brazilian Transgender Women (The BeT Study): Protocol for an Intervention Study. JMIR Res Protoc. 2023 Feb 3;12:e44157. doi: 10.2196/44157.

  PMID: 36735296 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Social Stigma; Helping Behavior

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regulatory Affairs Associate

Model Details: With this study, it is expected to evaluate the modification associated with the BeT intervention in prevention (engagement and adherence to PrEP) and in HIV treatment (attachment to care). Clinical trials are a powerful tool for the evaluation of health interventions, whether drug or not. Through this study, it will be possible to assess the effectiveness of a digital intervention based on peer browsing in HIV prevention and care. As this is a study with only one arm, this can interfere with obtaining measurements or verifying outcomes. To minimize the possibility of bias, the assessment of outcomes will be performed by people other than those administering the intervention. In addition, we will benchmark against an outside group, with information from the Ministry of Health's national registry systems, to determine the effect of our intervention on engagement and adherence to PrEP and linkage to HIV care.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 29, 2022
• Study Start: February 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: January 30, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)