Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000642886
Ethics application status
Approved
Date submitted
14/06/2012
Date registered
18/06/2012
Date last updated
28/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Positive Outlook Study: a randomised controlled trial evaluating the effectiveness of an online self management program for men living with HIV
Scientific title
A randomised controlled trial evaluating the effectiveness of 'Positive Outlook', an online self management program for men living with HIV on improving health related outcomes as measured by the heiQ compared to usual care control.
Secondary ID [1] 280510 0
Nil
Universal Trial Number (UTN)
U1111-1130-8643
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 286497 0
Condition category
Condition code
Infection 286757 286757 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Mental Health 287012 287012 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positive Outlook is a 7 week group self management program for men living with HIV. The program is delivered via a website. Participants will be required to log on to the program for at least 90minutes per week and complete relevant modules, activities and contribute to discussion boards. The intervention is guided by the theoretical framework of self management theory and self efficacy theory.
Intervention code [1] 284881 0
Behaviour
Intervention code [2] 285094 0
Lifestyle
Comparator / control treatment
Usual care: Participants will continue with their usual doctors appointments and any extra counselling or other supports they may be receiving.
Control group
Active

Outcomes
Primary outcome [1] 287143 0
Primary Outcome 1: outcomes of health education as assessed by the heiQ
Timepoint [1] 287143 0
Baseline, immediately after intervention completion and at 12 week follow up.
Primary outcome [2] 287175 0
Primary Outcome 2: domain specific self efficacy as assessed by a survey specifically designed for this study
Timepoint [2] 287175 0
Baseline, immediately after intervention completion and at 12 week follow up.
Primary outcome [3] 287627 0
Primary Outcome 3: quality of life as assessed by the PROQOL-HIV
Timepoint [3] 287627 0
Baseline, immediately after intervention completion and at 12 week follow up.
Secondary outcome [1] 297478 0
General health and quality of life as measured by the SF12
Timepoint [1] 297478 0
Baseline, immediately after intervention completion and at 12 week follow up.
Secondary outcome [2] 297479 0
Depression as measured by the Depression Anxiety and Stress Scale (DASS21)
Timepoint [2] 297479 0
Baseline, immediately after intervention completion and at 12 week follow up.
Secondary outcome [3] 297480 0
Social support as measured by the Duke Social Support Index (DSSI)
Timepoint [3] 297480 0
Baseline, immediately after intervention completion and at 12 week follow up.
Secondary outcome [4] 297481 0
Self efficacy as measured by the Generalised Self Efficacy Scale (GSE)
Timepoint [4] 297481 0
Baseline, immediately after intervention completion and at 12 week follow up.
Secondary outcome [5] 297482 0
Adjustment to HIV as measured by the Mental Adjustment to HIV Scale (MAH)
Timepoint [5] 297482 0
Baseline, immediately after intervention completion and at 12 week follow up.

Eligibility
Key inclusion criteria
HIV positive (self report)
Over 18 years old
Male
Self identifies as gay or MSM (men who have sex with men)
Ability to independently access a computer and use the internet for at least 90minutes per week for 7 weeks
Ability to read, write and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled once pre test questionnaires have been returned and allocated to either the intervention or control group by computerised central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2012
Actual
3/12/2012
Date of last participant enrolment
Anticipated
Actual
3/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285270 0
Charities/Societies/Foundations
Name [1] 285270 0
Bequest: The Western Australian AIDS Council
Country [1] 285270 0
Australia
Funding source category [2] 285271 0
Government body
Name [2] 285271 0
Department of Health: Communicable Disease Control Directorate: Sexual Health and Blood-Borne Virus Porgram
Country [2] 285271 0
Australia
Funding source category [3] 285272 0
University
Name [3] 285272 0
Edith Cowan University
Country [3] 285272 0
Australia
Funding source category [4] 285705 0
Other Collaborative groups
Name [4] 285705 0
National Association of People Living with HIV/AIDS (NAPWA)
Country [4] 285705 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Faculty of Medicine, Nursing and Health Sciences
Monash University,
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 284134 0
Individual
Name [1] 284134 0
Tanya Millard
Address [1] 284134 0
PO BOX 993
Williamstown
VIC 3016
Country [1] 284134 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287287 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 287287 0
Ethics committee country [1] 287287 0
Australia
Date submitted for ethics approval [1] 287287 0
Approval date [1] 287287 0
Ethics approval number [1] 287287 0
Ethics committee name [2] 290473 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 290473 0
Ethics committee country [2] 290473 0
Australia
Date submitted for ethics approval [2] 290473 0
Approval date [2] 290473 0
28/02/2013
Ethics approval number [2] 290473 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34193 0
Mrs Tanya Millard
Address 34193 0
Monash University
Level 5, Alfred Centre,
99 Commercial Road
Melbourne, Victoria, Australia 3004
Country 34193 0
Australia
Phone 34193 0
+61421049706
Fax 34193 0
Email 34193 0
[email protected]
Contact person for public queries
Name 17440 0
Tanya Millard
Address 17440 0
PO BOX 993
Williamstown,
VICTORIA,
3013
Country 17440 0
Australia
Phone 17440 0
+61421049706
Fax 17440 0
Email 17440 0
[email protected]
Contact person for scientific queries
Name 8368 0
Tanya Millard
Address 8368 0
PO BOX 993
Williamstown,
VICTORIA,
3013
Country 8368 0
Australia
Phone 8368 0
+61421049706
Fax 8368 0
Email 8368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.