HIV InfectionsNCT04930614
Prevalence and Risk Factors of HIV Infections in Transgender and Non-binary People in Flanders and Brussels (Belgium)
An observational study of HIV Infections, run by Centre for Evidence-Based Practice, Belgium at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour
- How many people
- 1,068 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2021to 11 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cisgender people
- People who have no understanding of the multilingual survey
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- HIV Infections
- Being tested
- Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour
- Keywords
- HIV, Transgender and non-binary people, LGBT+, time-location sampling, risk factor
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviourOther
Digital survey to estimate the associated risk factors for HIV infections in transgender and non-binary people in Flanders and Brussels (Belgium)
| Study group | Role | What they receive |
|---|---|---|
| Transgender and non-binary people | Adult transgender and non-binary people in Flanders and Brussels (Belgium) Receives: Other: Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study duration (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Dec 2021
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Evidence-Based Practice, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Institute of Tropical Medicine, Belgium, Institute for the Equality of Women and Men, Belgium, Gilead Sciences, Belgian Red Cross
- Responsible party
- Sponsor
- Investigators
- Guy T'Sjoen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930614
- Sponsor's protocol ID
- HIV-001
- Status last verified
- Aug 2023
- First submitted
- 11 Jun 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Brier N, Van Schuylenbergh J, Van Remoortel H, Van den Bossche D, Fieuws S, Molenberghs G, De Buck E, T'Sjoen G, Compernolle V, Platteau T, Motmans J. Prevalence and associated risk factors of HIV infections in a representative transgender and non-binary population in Flanders and Brussels (Belgium): Protocol for a community-based, cross-sectional study using time-location sampling. PLoS One. 2022 Apr 11;17(4):e0266078. doi: 10.1371/journal.pone.0266078. eCollection 2022.
PubMed 35404977
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04930614
- Acronym / sponsor ID
- HIV-001
- Conditions
- HIV Infections
- Keywords
- HIV, Transgender and non-binary people, LGBT+, time-location sampling, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,068 participants (actual)
- Lead sponsor
- Centre for Evidence-Based Practice, BelgiumUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Institute of Tropical Medicine, Belgium, Institute for the Equality of Women and Men, Belgium, Gilead Sciences, Belgian Red Cross
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender and non-binary people | – | Other: Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviourAdult transgender and non-binary people in Flanders and Brussels (Belgium) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cisgender people
- People who have no understanding of the multilingual survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviourDigital survey to estimate the associated risk factors for HIV infections in transgender and non-binary people in Flanders and Brussels (Belgium) | Other | Transgender and non-binary people |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 35404977De Brier N, Van Schuylenbergh J, Van Remoortel H, Van den Bossche D, Fieuws S, Molenberghs G, De Buck E, T'Sjoen G, Compernolle V, Platteau T, Motmans J. Prevalence and associated risk factors of HIV infections in a representative transgender and non-binary population in Flanders and Brussels (Belgium): Protocol for a community-based, cross-sectional study using time-location sampling. PLoS One. 2022 Apr 11;17(4):e0266078. doi: 10.1371/journal.pone.0266078. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy T'Sjoen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Centre for Evidence-Based Practice, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV infection (time frame: Study duration (one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04930614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.