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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02178930




Registration number
NCT02178930
Ethics application status
Date submitted
29/06/2014
Date registered
1/07/2014
Date last updated
30/08/2017

Titles & IDs
Public title
HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV
Scientific title
HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV
Secondary ID [1] 0 0
U1111-1150-6489
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Integrated self management support

Other: Integrated self management support - The intervention involves the introduction of an interactive chronic disease support platform into doctor-patient consultations, in addition to a self-management support program. Specifically, the intervention comprises the following interlinked components: within consultation engagement; at home exploration; phone and web-based health coaching.

No Intervention: Usual care - The control group will receive usual care from study sites until all study participants have completed 12 months of follow up from their Baseline Visits. At this point access to the study intervention will be expanded to include control sites.


Other interventions: Integrated self management support
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Cardiovascular risk as estimated by an HIV-specific risk score
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Fasting total cholesterol and total cholesterol:HDL ratio
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Systolic blood pressure
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Body mass index and waist circumference
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Proportion of patients achieving Australian cardiovascular risk factor management targets
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Quality of life as measured by the AQoL-4D instrument
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Mental health status as measured by the DASS instrument
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Self-management capacity as measured by the heiQ instrument
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Proportion of patients with HIV virological suppression
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Proportion of patients achieving HIV quality of care measures
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Evaluation of the intervention program (intervention arm only)
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Health care provider related: Evaluation of the intervention program intervention arm only)
Timepoint [14] 0 0
12 months

Eligibility
Key inclusion criteria
- •HIV infected adults aged 30 years or over.

- Receiving ongoing primary HIV and general care at a study site and likely to
remain in follow up at that site for 12 months.

- Willing and able to provide written informed consent.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- •Diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or
transient ischaemia attack, or peripheral arterial disease.

- Previous participation in a self-management or coaching program.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2017
Sample size
Target
Accrual to date
Final
731
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Fountain Street General Practice - Alexandra
Recruitment hospital [2] 0 0
Coffs Central Medical Centre - Coffs Harbour
Recruitment hospital [3] 0 0
CPC Medical Practice - Port Macquarie
Recruitment hospital [4] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [5] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [6] 0 0
Riverside Family Medical Practice - Adelaide
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment hospital [9] 0 0
Northside Clinic - Melbourne
Recruitment hospital [10] 0 0
Richmond Hill Medical Centre - Melbourne
Recruitment hospital [11] 0 0
Recreation Medical Centre - Melbourne
Recruitment hospital [12] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [13] 0 0
Prahran Market Clinic - Melbourne
Recruitment hospital [14] 0 0
Centre Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
2015 - Alexandra
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
5042 - Adelaide
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3053 - Melbourne
Recruitment postcode(s) [8] 0 0
3068 - Melbourne
Recruitment postcode(s) [9] 0 0
3121 - Melbourne
Recruitment postcode(s) [10] 0 0
3143 - Melbourne
Recruitment postcode(s) [11] 0 0
3168 - Melbourne
Recruitment postcode(s) [12] 0 0
3181 - Melbourne
Recruitment postcode(s) [13] 0 0
3182 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Karen Klassen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National Association of People with HIV Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
National Health and Medical Research Council, Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Victorian AIDS Council
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Department of Health & Human Services, State Government of Victoria, Australia
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Flinders University
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Living Positive Victoria
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
NSW Ministry of Health
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University of Melbourne
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Deakin University
Address [12] 0 0
Country [12] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to improve the health status of people living with HIV in
Australia. The overall goal is to rigorously evaluate the impact of interactive health plans
and self-management support on chronic condition outcomes in people with HIV.

The specific aims are to:

Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive
health plans and self-management support on coronary heart disease risk and other chronic
condition outcomes in people living with HIV.

Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive
health plans and self-management support.

Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02178930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julian Elliott
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02178930