Trans People Living With HIV Throughout Europe

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    200
  • sponsor
    Chelsea and Westminster NHS Foundation Trust
Updated on 16 August 2021
antiretroviral
HIV Infection
antiretroviral agents
antiretroviral therapy
hiv viral load
HIV Vaccine

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).

Details
Condition Immunodeficiency, HIV, HIV/AIDS, Primary Immunodeficiency Disorders, HIV infection, Gender, human immunodeficiency virus, HIV (Pediatric), hiv disease, HIV Infections
Clinical Study IdentifierNCT03922269
SponsorChelsea and Westminster NHS Foundation Trust
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

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.)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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