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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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 11, 2019
Primary Completion Date
December 17, 2025
Completion Date
December 17, 2025
Last Updated
December 23, 2025
200
ACTUAL participants
Lead Sponsor
Chelsea and Westminster NHS Foundation Trust
Collaborators
NCT07071623
NCT07115901
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07236905