Trans People Living With HIV Throughout Europe (TIME)

May 3, 2023 updated by: Chelsea and Westminster NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy
        • Recruiting
        • Servizio Sanitario Nazionale Regione Piemonte Azienda Sanitaria Locale "Citta di Torino" Department of Medical Sciences, University of Turin
        • Contact:
          • Data Manager
          • Phone Number: +393886932938
        • Principal Investigator:
          • Andrea Calcagno
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
        • Recruiting
        • Chelsea And Westminster Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sally Jewsbury
    • Sussex
      • Brighton, Sussex, United Kingdom, BN2 1DH
        • Recruiting
        • Elton John Centre, Brighton and Sussex University Hospitals
        • Contact:
          • Lead Research Nurse
          • Phone Number: 01273 523079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of virological response to antiretroviral therapy
Time Frame: 18 months
Proportion of cohort achieving viral suppression as measured in viral load serum assays.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

ViiV Healthcare

Investigators

  • Principal Investigator: Marta Boffito, MD, PhD, Chelsea and Westminster NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2019

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

October 30, 2025

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C&W19/003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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