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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 : April 19, 2019
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

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.


Condition or disease
HIV Infections Gender Identity Human Immunodeficiency Virus

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).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trans People Living With HIV Throughout Europe
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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.



Primary Outcome Measures :
  1. Rate of virological response to antiretroviral therapy [ Time Frame: 18 months ]
    Proportion of cohort achieving viral suppression as measured in viral load serum assays.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people).
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people) They must be 18 years old or above, have a diagnosis of HIV and have been prescribed antiretroviral therapy at any time.
Criteria

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.)

Information from the National Library of Medicine

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


Contacts
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Contact: Research Delivery Operations Manager 020 3315 6825 research.development@chelwest.nhs.uk

Locations
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United Kingdom
Chelsea and Westminster Hospital Not yet recruiting
London, Greater London, United Kingdom, SW10 9NH
Contact: Research Delivery Operations Manager    020 3315 6825    research.development@chelwest.nhs.uk   
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
ViiV Healthcare
Investigators
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Principal Investigator: Marta Boffito, MD, PhD Chelsea and Westminster Hospital NHS Foundation Trust

Additional Information:
Publications:
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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03922269     History of Changes
Other Study ID Numbers: C&W19/003
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases