Trans People Living With HIV Throughout Europe (TIME)
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|ClinicalTrials.gov Identifier: NCT03922269|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : August 12, 2019
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.
|Condition or disease|
|HIV Infections Gender Identity Human Immunodeficiency Virus|
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:
- 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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Trans People Living With HIV Throughout Europe|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
- Rate of virological response to antiretroviral therapy [ Time Frame: 18 months ]Proportion of cohort achieving viral suppression as measured in viral load serum assays.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922269
|Contact: Research Delivery Operations Manager||020 3315 firstname.lastname@example.org|
|Chelsea and Westminster Hospital||Not yet recruiting|
|London, Greater London, United Kingdom, SW10 9NH|
|Contact: Research Delivery Operations Manager 020 3315 6825 email@example.com|
|Principal Investigator:||Marta Boffito, MD, PhD||Chelsea and Westminster Hospital NHS Foundation Trust|