Gender Identity, HIV Infections, Human Immunodeficiency Virus
Conditions
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.
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).
Interventions
None listed
Sponsors
ViiV Healthcare
Chelsea and Westminster NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of virological response to antiretroviral therapy | 18 months | Proportion of cohort achieving viral suppression as measured in viral load serum assays. |
Countries
Italy, United Kingdom
Outcome results
None listed