Trans People Living With HIV Throughout Europe

NCT03922269 | Completed

• 1 other identifier: C&W19/003
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 4

Brief Summary

The project will study a European cohort of individuals identifying themselves as transgender or non-binary and living with HIV. 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.

Conditions

Gender Identity; HIV Infections; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Rate of virological response to antiretroviral therapy

  Proportion of cohort achieving viral suppression as measured in viral load serum assays.

  18 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people) They must be 18 years old or above, have a diagnosis of HIV and have been prescribed antiretroviral therapy at any time.

You may qualify if:

• Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people)
• 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

You may not qualify if:

• Age \< 18 years
• 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.)

Sponsors & Collaborators

• ViiV Healthcare: collaborator
• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (4)

Servizio Sanitario Nazionale Regione Piemonte Azienda Sanitaria Locale "Citta di Torino" Department of Medical Sciences, University of Turin

Torino, Italy

Location

Chelsea and Westminster Hospital

London, Greater London, SW10 9NH, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Location

Elton John Centre, Brighton and Sussex University Hospitals

Brighton, Sussex, BN2 1DH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23260128 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24714446 BACKGROUND

• 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.

  PMID: 29409344 BACKGROUND

• 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.

  PMID: 17694429 BACKGROUND

Related Links

• HIV/AIDS surveillance in Europe 2018 - 2017 data
• UNAIDS
• WHO policy brief - Transgender people and HIV

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Marta Boffito, MD, PhD

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: October 11, 2019
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (3)