Cardiovascular Disease, HIV-1 Infection
Conditions
Keywords
Cardiovascular disease, HIV, Antiretroviral treatment, team interventions, Framingham risk score
Brief summary
This is a cohort study which follows two groups of participants over a 12 months period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period. The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterol levels
Interventions
OTHERControl
GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
OTHERIntervention Group
Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
Sponsors
Holdsworth House Medical Practice
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
intervention study intervention arm Inclusion criteria: 1. Documented HIV-1 infection 2. Age 50 years or older 3. Stable on ART ≥ 3/12 4. Undetectable plasma HIV RNA (\< 50 copies/ml) 5. Moderate or high Framingham CVD risk score 6. Life expectancy \> 12 months 7. Regular patient under care of non-director physician 8. Willing to adhere to pharmacological CVD risk reduction intervention 9. Willing to participate in lifestyle change advice intervention
Exclusion criteria
for intervention study 1. Life expectancy \< 1yr 2. Unable to undertake exercise 3. Drug dependency 4. Cognitive impairment affecting ability to participate in study 5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5mI U/ml) 6. Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study Inclusion criteria for intervention study control arm (Group 2) 1. Documented HIV-1 infection 2. Age 50 years or older 3. Stable on ART ≥3/12 4. Undetectable plasma HIV RNA (\<50 copies/ml) 5. Moderate or high Framingham risk score (\>10%) 6. Life expectancy \> 12 months 7. Regular patient under care of non-director physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. | 12 months | The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. |
Countries
Australia
Outcome results
None listed