Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months

Study Overview
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Brief Summary
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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

Official Title
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Effectiveness of Team Intervention Over 12 Months in Reducing Modifiable CVD Risk Factors on Framingham 10yr Risk Scores Outcomes in HIV-1 Subjects on Antiretroviral Therapy

Conditions
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HIV-1 Infection, Cardiovascular Disease

Intervention / Treatment
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* Other: Control
* Other: Intervention Group


Participation Criteria
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Eligibility Criteria
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intervention study intervention arm Inclusion criteria: Documented HIV-1 infection Age 50 years or older Stable on ART ≥ 3/12 Undetectable plasma HIV RNA (< 50 copies/ml) Moderate or high Framingham CVD risk score Life expectancy > 12 months Regular patient under care of non-director physician Willing to adhere to pharmacological CVD risk reduction intervention Willing to participate in lifestyle change advice intervention Exclusion criteria for intervention study Life expectancy < 1yr Unable to undertake exercise Drug dependency Cognitive impairment affecting ability to participate in study 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) 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) Documented HIV-1 infection Age 50 years or older Stable on ART ≥3/12 Undetectable plasma HIV RNA (<50 copies/ml) Moderate or high Framingham risk score (>10%) Life expectancy > 12 months Regular patient under care of non-director physician

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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. | Other: Control<br>* 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.<br>|
| Active Comparator: Usual care (control) group<br>Within the context of an open, cohort study, 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. | Other: Intervention Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. | The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease, HIV, Antiretroviral treatment, team interventions, Framingham risk score