Prevalence and Risk Factors of HIV Infections in Transgender and Non-binary People in Flanders and Brussels (Belgium)

HIV Infections Clinical Trial

Official title:

Prevalence and Associated Risk Factors of HIV Infections in a Representative Transgender and Non-binary Population in Flanders and Brussels (Belgium): A Community-based, Cross-sectional Study Using Time-location Sampling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930614
• Other study ID #: HIV-001
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: July 11, 2023

Study information

• Verified date: August 2023
• Source: Centre for Evidence-Based Practice, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: HIV prevalence and sexual risk have been estimated very high for transgender people. However, the limited sampling and data collection methods used in current research on transgender people potentially led to overrepresentation and generalisation of people at risk for HIV. Current HIV prevalence estimates in transgender populations are generalised from studies mainly focusing on transgender women who engage in sex work. Moreover, current research remains cisnormative, and studies focusing on non-binary people, who identify with a broad range of identities beyond the traditional male and female gender identities, are scarce. Objective: This study aims to estimate the HIV prevalence rate in the Flemish and Brussels (Belgium) transgender population, including transgender women as well as transgender men and non-binary people, and identifying the associated individual and community-level risk factors. Methods: In this community-based cross-sectional study, self-identified transgender and non-binary (TGNB) people will be recruited through a two-stage time-location sampling approach to minimize selection bias. In a first part, community settings in which TGNB people gather will be mapped using qualitative and ethnographic research methods, to reveal how the TGNB community in Flanders and Brussels is structured and to develop an accurate sampling frame. In a second part, to select the respondents, a multistage sampling design is applied involving a stratification based on setting type (healthcare facilities vs outreach events), a selection of clusters by systematic sampling and a simple random selection of TGNB people within each cluster. Participants will complete an electronic self-reported survey to measure sociological, sexual and drug-using behaviors (risk factors) and, at the same time, oral fluid aliquots will be collected and tested for HIV antibodies. Logistic regression models will be used to evaluate risk factors independently associated with HIV infection. Conclusion: To the best of our knowledge, this study will be the first to investigate the HIV prevalence rates and behaviors that increase risk and vulnerability for HIV infection in an accurate representation of the TGNB population in a West European country. The findings of this study will globally serve as a knowledge base for identifying subgroups at risk for becoming infected with HIV within TGNB people and to set up targeted prevention programs on sexual health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1068
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (= 18 years) self-identified transgender and non-binary people
• Able to read, write and understand the survey
• Consent to participate in the survey and to self-collect an oral fluid sample

Exclusion Criteria:

• Cisgender people
• People who have no understanding of the multilingual survey

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

Intervention

Other:
• Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour
Digital survey to estimate the associated risk factors for HIV infections in transgender and non-binary people in Flanders and Brussels (Belgium)

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent	Ghent	Oost-Vlaanderen

Sponsors (6)

Lead Sponsor	Collaborator
Centre for Evidence-Based Practice, Belgium	Belgian Red Cross, Gilead Sciences, Institute for the Equality of Women and Men, Belgium, Institute of Tropical Medicine, Belgium, University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV infection	Oral fluid samples will be self-collected by the participants through swabbing and tested for the presence of HIV antibodies with the DPP HIV1/2 Assay (Chembio Diagnostic Systems, Inc) at the Institute of Tropical Medicine.	Study duration (one year)