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NCT03922269 Clinical Trial

Trans People Living With HIV Throughout Europe

HIV Infections Clinical Trial

— TIME  

Official title:
Trans People Living With HIV Throughout Europe

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03922269
Other study ID # C&W19/003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 11, 2019
Est. completion date October 30, 2025

Study information
Verified date May 2023
Source Chelsea and Westminster NHS Foundation Trust
Contact Research Delivery Operations Manager
Phone 020 3315 6825
Email research.development@chelwest.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date October 30, 2025
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Servizio Sanitario Nazionale Regione Piemonte Azienda Sanitaria Locale "Citta di Torino" Department of Medical Sciences, University of Turin Torino
United Kingdom Elton John Centre, Brighton and Sussex University Hospitals Brighton Sussex
United Kingdom Chelsea and Westminster Hospital London Greater London
United Kingdom Manchester University NHS Foundation Trust Manchester Greater Manchester

Sponsors (2)
Lead Sponsor Collaborator
Chelsea and Westminster NHS Foundation Trust ViiV Healthcare

Countries where clinical trial is conducted

Italy,  United Kingdom, 

References & 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. — View 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. — View 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. — View 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. — View 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.

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of virological response to antiretroviral therapy Proportion of cohort achieving viral suppression as measured in viral load serum assays. 18 months
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