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出境医 / 临床实验 / Prevalence and Risk Factors of HIV Infections in Transgender and Non-binary People in Flanders and Brussels (Belgium)

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

Study Description
Brief 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.


Condition or disease Intervention/treatment
HIV Infections Other: Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1322 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Transgender and non-binary people
Adult transgender and non-binary people in Flanders and Brussels (Belgium)
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)

Outcome Measures
Primary Outcome Measures :
  1. HIV infection [ Time Frame: Study duration (one year) ]
    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.


Biospecimen Retention:   Samples With DNA
Oral fluid aliquots

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender women and transgender men, as well as non-binary people are included in this study. Transvestite or crossdressing people who identify as transgender are also included.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population involves transgender (identifying more with the opposite gender than the gender which was assigned at birth) and non-binary (identifying with both or neither binary genders) people in Flanders and Brussels.
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Judith Van Schuylenbergh, Msc +32 9 332 57 25 judith.vanschuylenbergh@uzgent.be
Contact: Niels De Brier, PhD +32 15 44 34 19 niels.debrier@cebap.org

Locations
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Belgium
University Hospital, Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Judith Van Schuylenbergh, Msc    +32 9 332 57 25    judith.vanschuylenbergh@uzgent.be   
Sponsors and Collaborators
Centre for Evidence-Based Practice, Belgium
University Hospital, Ghent
Institute of Tropical Medicine, Belgium
Institute for the Equality of Women and Men, Belgium
Gilead Sciences
Belgian Red Cross
Investigators
Layout table for investigator information
Principal Investigator: Guy T'Sjoen, MD, PhD University Hospital, Ghent
Tracking Information
First Submitted Date June 11, 2021
First Posted Date June 18, 2021
Last Update Posted Date June 18, 2021
Estimated Study Start Date September 1, 2021
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2021)
HIV infection [ Time Frame: Study duration (one year) ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence and Risk Factors of HIV Infections in Transgender and Non-binary People in Flanders and Brussels (Belgium)
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
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Oral fluid aliquots
Sampling Method Probability Sample
Study Population The study population involves transgender (identifying more with the opposite gender than the gender which was assigned at birth) and non-binary (identifying with both or neither binary genders) people in Flanders and Brussels.
Condition HIV 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)
Study Groups/Cohorts Transgender and non-binary people
Adult transgender and non-binary people in Flanders and Brussels (Belgium)
Intervention: Other: Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 11, 2021)
1322
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Transgender women and transgender men, as well as non-binary people are included in this study. Transvestite or crossdressing people who identify as transgender are also included.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Judith Van Schuylenbergh, Msc +32 9 332 57 25 judith.vanschuylenbergh@uzgent.be
Contact: Niels De Brier, PhD +32 15 44 34 19 niels.debrier@cebap.org
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT04930614
Other Study ID Numbers HIV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Centre for Evidence-Based Practice, Belgium
Study Sponsor Centre for Evidence-Based Practice, Belgium
Collaborators
  • University Hospital, Ghent
  • Institute of Tropical Medicine, Belgium
  • Institute for the Equality of Women and Men, Belgium
  • Gilead Sciences
  • Belgian Red Cross
Investigators
Principal Investigator: Guy T'Sjoen, MD, PhD University Hospital, Ghent
PRS Account Centre for Evidence-Based Practice, Belgium
Verification Date June 2021