HEATHER MA

  • Research type

    Research Study

  • Full title

    HEATHER MA: HIV Reservoir targeting with Early Antiretroviral Therapy: Microbiome and Attitudes

  • IRAS ID

    250068

  • Contact name

    Julie Fox

  • Contact email

    julie.fox@kcl.ac.uk

  • Sponsor organisation

    Guy's & St. Thomas' NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 2 months, 29 days

  • Research summary

    The 'HEATHER MA' study plans to explore links between the microbiome and HIV reservoir and ask individuals about their attitudes towards treatment interruption as part of a HIV 'cure' study. This study represents one of the first evaluations of the relationship between microbiome and HIV reservoir. The former requires a rectal swab and the latter involves completing an online questionnaire which takes approximately 15 minutes to complete. The questionnaire addresses key issues in HIV cure research in order to gain an understanding of the beliefs about 'cure', motivations and concerns about taking part in 'cure' studies in this specific group of individuals.

    To do this, the HEATHER MA study will recruit individuals already participating in a ‘cure’ study, the HEATHER study. The HEATHER study is a longitudinal observational study designed to characterise the HIV reservoir in patients treated since primary HIV infection. To date 300+ individuals have been recruited and the participants have been characterised in terms of the parts of the immune system where the virus remains in a dormant (viral reservoir) and how this impacts the immune system (immune activation). The relationship of microbiome to this has had limited investigation, and neither has patient attitudes towards stopping treatment (treatment interruption). The latter is vital to design future 'cure' studies, where the amount of virus in the body does not increase, despite not taking HIV drugs. Patient concerns and opinions will be incorporated into this from the beginning. By evaluating this group of patients we aim to inform the debate regarding the factors and mechanisms that may be associated with a low viral reservoir as well as providing an ethical evidence base for future treatment interruption studies.

  • REC name

    West of Scotland REC 5

  • REC reference

    19/WS/0120

  • Date of REC Opinion

    16 Aug 2019

  • REC opinion

    Favourable Opinion