Melbourne HIV Cohort Study


Background and Rationale

Despite a dramatic improvement in life expectancy in patients living with HIV since the introduction of antiretroviral therapy there is still a significant gap compared with the general population. In Australia the majority of morbidity and mortality in the HIV positive population does not result from infectious complications but from chronic conditions such as cardiovascular disease, liver and renal disease. It is likely that these conditions result from a combination of the HIV infection itself, anti-retroviral toxicity, health behaviours and underlying risks.
The aim of this study is to establish a multi-centre cohort of HIV positive and HIV negative patients as a basis for further research into these chronic conditions that now significantly affect the lives of people living with HIV.

Objectives
1. Establish and follow a cohort of HIV treatment naïve patients with HIV negative controls, in order perform and facilitate a wide range of high quality research projects of relevance to people living with HIV.
2. To create a partnership and infrastructure that encourages high quality collaborative HIV basic, clinical and behavioural science research.

Patient Population
The study will enrol 100 HIV positive cases and 100 HIV negative controls over a 2 year period
1. Inclusion criteria for HIV positive cases are:
a) Less than 7 days of prior HIV antiretroviral treatment since HIV diagnosis and less than 1 month of anti-retroviral exposure for post-exposure prophylaxis in the year prior to enrolment if they had a negative HIV test following anti-virals.
b) Age ≥ 18 years old
c) Regularly attending and likely to continue in follow up
d) Willing and able to provide written informed consent

2. Inclusion criteria for HIV negative control group are:
a) Male
b) Identify as having male sexual partners
c) Negative HIV test within past 12 months
d) Less than 1 month of anti-retoviral exposure in form of post-exposure prophylaxis (PEP) in the year prior to enrolment. Patients that have had PEP must have a negative HIV test after completing the anti-retroviral course.
e) Age ≥ 18 years old
f) Regularly attending and likely to continue in follow up
g) Willing and able to provide written informed consent

Study Design
Prospective observational cohort study.
Patients will have major clinical visits annually which will include:
a. Clinical history of demographic and socioeconomic details, past medical history, major clinical events and medications
b. Collection of investigation results performed as routine clinical care
c. Completion of confidential questionnaires about mental health, drug and alcohol use, quality of life and sexual satisfaction
d. Height, weight and blood pressure measurements
e. Collection of blood for storage

At baseline and every 2nd annual visit this will also include:
a. Carotid intimal medial thickening assessment (cIMT)
b. Electrocardiogram (ECG)
c. DEXA bone scan
d. Neurocognitive screening

At six month intervals there will be a brief visit or telephone consult to review major clinical events, hospitalisations, and change to medications.
In the HIV positive group there will also be visits at 3 and 6 months after antiretroviral therapy is commenced. This will involve collection of clinical and laboratory results as for the annual visit but will not involve questionnaires or additional investigations.

Participating Sites

  • Alfred Hospital
  • Centre Clinic
  • Melbourne Sexual Health Centre
  • Monash Infectious Diseases
  • Northside Clinic
  • Prahran Market Clinic
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