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Trans People Living With HIV Throughout Europe — TIME  

HIV Infections Clinical Trial

Official title:
Trans People Living With HIV Throughout Europe

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03922269
Study type Observational
Source Chelsea and Westminster NHS Foundation Trust
Contact Research Delivery Operations Manager
Phone 020 3315 6825
Email research.development@chelwest.nhs.uk
Status Recruiting
Phase
Start date October 11, 2019
Completion date October 30, 2025
View Details
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