Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months - Full Text View

Purpose

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

Condition	Intervention
HIV-1 Infection Cardiovascular Disease	Other: Control Other: Intervention Group


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Dr. Mark Bloch, Holdsworth House Medical Practice:

Primary Outcome Measures:

The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52. [ Time Frame: 12 months ]
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.


Enrollment:	92
Study Start Date:	October 2011
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intervention 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.	Other: Control 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.
Active Comparator: Usual care (control) group 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 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.

Arms

Assigned Interventions

Active Comparator: Intervention 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.

Other: Control

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.

Active Comparator: Usual care (control) group

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

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.

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436136

Locations


Australia, New South Wales
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010

Sponsors and Collaborators

Holdsworth House Medical Practice

Investigators


Principal Investigator:	Mark T Bloch	Australian Health Practitioner Regulation Agency

More Information


Responsible Party:	Dr. Mark Bloch, Doctor, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:	NCT01436136 History of Changes
Other Study ID Numbers:	Reducing CVD risk in HIV
Study First Received:	September 14, 2011
Last Updated:	May 10, 2015

Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:


Cardiovascular disease HIV Antiretroviral treatment team interventions Framingham risk score

Additional relevant MeSH terms:


Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 17, 2017

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