Trans People Living With HIV Throughout Europe (TIME)

Chelsea and Westminster NHS Foundation Trust

Status: Enrolling

Conditions: Human Immunodeficiency Virus; Gender Identity; HIV Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03922269

C&W19/003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

200 participants in 1 patient group

Transgender individual with a diagnosis of HIV

Description:

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.