Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-10-11
2025-12-17
Brief Summary
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The study will collect both qualitative data on this cohort and clinical data over an 18 month period. The study will investigate the success of HIV treatment for this cohort through the primary outcome measure of HIV viral load recorded in routine blood tests.
The results from this study will assist in informing future HIV treatment guidelines on the monitoring of HIV infection in transgender and non-binary individuals and assisting in the design of future interventional studies within this population.
Detailed Description
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The primary aim is to assess the rate of virological response to antiretroviral therapy in transgender and non-binary (gender diverse) people living with HIV (TPLWH) in Europe. It's secondary outcomes are:
* To explore demographics, risk behaviours and community needs
* To explore the barriers and facilitators to adherence to cART
* To report TPLWH experiences with regard to:
* Stigma
* Quality of life
* Prevalence of opportunistic infections
* To record data on:
* Retention into care
* Clinical characteristics (e.g. drug toxicity, BMD results, hormone intake, drug interactions between hormones and antiretrovirals, cardiovascular risk, etc.)
* Implement and analyse a trans-inclusive method of gender identity data collection, in order to provide comprehensive demographic information that is acceptable at the community-level and includes a diverse spectrum of trans/non-binary genders across all study sites. People living with HIV (PLWH) who refer to themselves as transgender and non-binary (and all gender diverse people).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Transgender individual with a diagnosis of HIV
The participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth, is 18 years old or above, has a diagnosis of HIV infection and has been prescribed antiretroviral therapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* HIV infection diagnosis at any time before study consent
* Having been prescribed antiretroviral therapy at any time (including people for who antiretroviral therapy initiation is planned after study enrolment)
* Willing to sign an informed consent and take part in the study
Exclusion Criteria
* Unable to take part in the study according to the Investigator opinion (example: unable to understand the study information leaflet, unable to provide written consent, etc.)
18 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Marta Boffito, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Locations
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Servizio Sanitario Nazionale Regione Piemonte Azienda Sanitaria Locale "Citta di Torino" Department of Medical Sciences, University of Turin
Torino, , Italy
Chelsea and Westminster Hospital
London, Greater London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Elton John Centre, Brighton and Sussex University Hospitals
Brighton, Sussex, United Kingdom
Countries
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References
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Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214-22. doi: 10.1016/S1473-3099(12)70315-8. Epub 2012 Dec 21.
Suchak et al. Highly invisible, highly infectious and high risk: the hidden problem of trans people living with HIV. 23rd Annual Conference of the British HIV Association (BHIVA), 2017. Liverpool, UK.
Santos GM, Wilson EC, Rapues J, Macias O, Packer T, Raymond HF. HIV treatment cascade among transgender women in a San Francisco respondent driven sampling study. Sex Transm Infect. 2014 Aug;90(5):430-3. doi: 10.1136/sextrans-2013-051342. Epub 2014 Apr 8.
Hibbert M, Wolton A, Crenna-Jennings W, Benton L, Kirwan P, Lut I, Okala S, Ross M, Furegato M, Nambiar K, Douglas N, Roche J, Jeffries J, Reeves I, Nelson M, Weerawardhana C, Jamal Z, Hudson A, Delpech V. Experiences of stigma and discrimination in social and healthcare settings among trans people living with HIV in the UK. AIDS Care. 2018 Jul;30(7):836-843. doi: 10.1080/09540121.2018.1436687. Epub 2018 Feb 6.
Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17. doi: 10.1007/s10461-007-9299-3. Epub 2007 Aug 13.
Related Links
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HIV/AIDS surveillance in Europe 2018 - 2017 data
UNAIDS
WHO policy brief - Transgender people and HIV
Other Identifiers
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C&W19/003
Identifier Type: -
Identifier Source: org_study_id