Clinical trial NCT03922269: Trans People Living With HIV Throughout Europe
Official title: Trans People Living With HIV Throughout Europe
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Gender Identity
Human Immunodeficiency Virus
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2019-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The TIME Study is a multi-centre cohort study, combined with a cross-sectional survey.The study will comprise recording clinical data from up to three visits over an 18-month period. The study visits will happen at the same time of routine clinical care, and all clinical data will be collected in the study database. At the screening/baseline study visit (following written consent), a survey will be administered to all study participants. The overall recruitment target is 200 participants.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Rate of virological response to antiretroviral therapy
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Servizio Sanitario Nazionale Regione Piemonte Azienda Sanitaria Locale "Citta di Torino" Department of Medical Sciences, University of Turin
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
state: Greater London
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
city: Brighton
country: United Kingdom
facility: Elton John Centre, Brighton and Sussex University Hospitals
state: Sussex
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Marta Boffito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.