Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 9:02 PM
Study NCT ID:
NCT03922269
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans People Living With HIV Throughout Europe
Sponsor:
Chelsea and Westminster NHS Foundation Trust
Organization:
Study Overview
Official Title:
Trans People Living With HIV Throughout Europe
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: