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 |
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HIV Infections | Other: Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour |
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 |
Group/Cohort | Intervention/treatment |
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Transgender and non-binary people
Adult transgender and non-binary people in Flanders and Brussels (Belgium)
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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)
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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 |
Inclusion Criteria:
Exclusion Criteria:
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 |
Belgium | |
University Hospital, Ghent | |
Ghent, Oost-Vlaanderen, Belgium, 9000 | |
Contact: Judith Van Schuylenbergh, Msc +32 9 332 57 25 judith.vanschuylenbergh@uzgent.be |
Principal Investigator: | Guy T'Sjoen, MD, PhD | University Hospital, Ghent |
Tracking Information | |||||||||
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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 |
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.
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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. |
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Detailed Description | Not Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description:
Oral fluid aliquots
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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)
|
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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
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Centre for Evidence-Based Practice, Belgium | ||||||||
Study Sponsor | Centre for Evidence-Based Practice, Belgium | ||||||||
Collaborators |
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Investigators |
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PRS Account | Centre for Evidence-Based Practice, Belgium | ||||||||
Verification Date | June 2021 |