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Trial registered on ANZCTR


Registration number
ACTRN12613000265774
Ethics application status
Approved
Date submitted
27/02/2013
Date registered
6/03/2013
Date last updated
23/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The SMART Study: Can a Smartphone Application Improve Adherence to Antiretroviral Therapy?
Scientific title
In patients with HIV infection can a smartphone application designed to enhance patients' understanding of their illness (compared to a reminder device), increase rates of adherence to antiretroviral therapy?
Secondary ID [1] 281816 0
Nil known
Universal Trial Number (UTN)
U1111-1137-4579
Trial acronym
The SMART Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV infection 288166 0
Condition category
Condition code
Infection 288529 288529 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (patients with HIV infection attending the Auckland City Hospital Infectious Diseases Unit) in the intervention group will receive an augmented smartphone application to use for three months (in addition to standard care).

The application contains three components designed to facilitate adherence to antiretroviral therapy (ART);
(a) 24 hour timer reminding the participant when to take their medications
(b) predicted blood concentrations of medications based on medication-taking as entered into the application by the patient
c) graphical representation of HIV & CD4 cell activity based on predicted medication concentrations and blood tests.

1. Standard care for patients with HIV infection at Auckland City Hospital is an appointment at the Infectious Diseases outpatient clinic once every six months (with either an Infectious Diseases consultant or specialist nurse) and a blood test once every three months (to determine CD4 count and HIV viral load). There is no additional care for participants taking part in the study.

2. Participants will be only asked to enter their medication use into the application. Thus, the frequency of use will depend on the complexity of their treatment regimen. Any use of the application in addition to entering medication use is completely at the participant’s discretion.
Intervention code [1] 286368 0
Treatment: Other
Comparator / control treatment
Participants in the control group will also receive a smartphone application to use for three months (in addition to standard care). However this application will only contain component (a) - the 24 hour timer reminding the participant when to take their medications.
Control group
Active

Outcomes
Primary outcome [1] 288686 0
HIV viral load (copies/ml)

The HIV viral load will be measured in the Virology Laboratory (Lab Plus, Auckland City Hospital) by the COBAS AmpliPrep/Taqman HIV-1 Test. This is a RT/PCR based assay that effectively detects all HIV-1 group M subtypes. It can quantitate HIV-1 RNA over the range of 20 - 10,000,000 copies/ml.
Timepoint [1] 288686 0
at three months after randomisation
Primary outcome [2] 288688 0
Medication Adherence Report Scale score
Timepoint [2] 288688 0
at three months after randomisation
Primary outcome [3] 292189 0
Pharmacy dispensings (the number and dates of dispensings of ART for each participant from 01 January 2012 to 01
September 2013, and the dates of any missed collections, were obtained from local pharmacy
records).
Timepoint [3] 292189 0
three months after randomisation
Secondary outcome [1] 300764 0
Brief Illness Perception Questionnaire (BIPQ) score
Timepoint [1] 300764 0
at three months after randomisation
Secondary outcome [2] 300765 0
CD4 count (cells/mm3)

The total and percentage of CD3, CD4 and CD8 positive cells will be measured by flow cytometry in the Cell Markers section of the Haematology Laboratory, (Lab Plus, Auckland City Hospital).
Timepoint [2] 300765 0
at three months after randomisation
Secondary outcome [3] 308396 0
Smartphone application usage
(i.e. the number of times that each participant viewed each particular component of their application, and
the amount of time spent on each component). Data were recorded on the smartphone application and analysed using Google analytics software.
Timepoint [3] 308396 0
one and two weeks after randomisation
one and three months after randomisation
Secondary outcome [4] 308397 0
Evaluation of smartphone application

Participants were asked how satisfied they were with the application and how useful they found each particular component for reminding them to take their medications. The questionnaire enquired about specific properties of the application, namely; ease of use, visual appeal, discretion, information provision, and an overall rating. Each item was rated on an 11-point scale (0 to 10) with relevant anchors.

Each participant was also asked whether they would recommend the application to other patients on ART, and (in an open-ended question format) which features of the application worked well, which features did not work well, and any improvements they would make to the application.
Timepoint [4] 308397 0
one and three months after randomisation

Eligibility
Key inclusion criteria
Every participant must be:
-on antiretroviral therapy for at least 6 months
-a patient at the Auckland City Hospital Infectious Diseases clinic
-over 18 years of age
-have a smartphone
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they:
-are under 18 years of age
-do not have a smartphone
-are unable to give informed consent
-are unable to speak, write and read English

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Sample Size Calculation: Previous randomised controlled trials of adherence-promoting mobile technologies for people living with HIV have found large effect sizes for differences between control and intervention groups (Lewis et al., 2013; Moore, Hardy, Skolnik, & Moss, 2011). A total sample size of 52 participants was estimated to be required, in order to detect a large effect size (f = 0.40) for a difference in self-reported adherence to ART between the active control group and intervention group. This calculation was on the basis of a power of .80 and an alpha level of .05, using a one-way between groups analysis of covariance (ANCOVA). To account for participant attrition, a total sample of 60 was deemed an appropriate target for recruitment.

Statistical Analysis: The data were analysed using the SPSS version 20.0 software (Chicago, Illinois). Data were assessed for normality, and non-parametric testing was employed for analysis of variables which did not have a normal distribution. One-way analyses of covariance (ANCOVAs), controlling for baseline measures of the outcome variable, were used to examine the effects of the intervention on adherence to treatment, perceptions of HIV infection, and beliefs about ART.

McNemar’s tests were conducted to ascertain if there were any differences in the proportion of non-adherent participants (as classified using the composite adherence measure) at baseline and three month follow-up, in the intervention and active control group. Correlational analyses were used to explore the relationships between application use, changes in illness perceptions and medication beliefs, and changes in adherence to ART. Independent samples t-tests were carried out to assess the effect of group allocation on application usage and evaluations of the smartphone application.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4818 0
New Zealand
State/province [1] 4818 0
Auckland

Funding & Sponsors
Funding source category [1] 286603 0
University
Name [1] 286603 0
The University of Auckland
Address [1] 286603 0
Private Bag 92019
Auckland
New Zealand

Postcode: 1010
Country [1] 286603 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland
New Zealand

Postcode: 1010
Country
New Zealand
Secondary sponsor category [1] 285390 0
None
Name [1] 285390 0
Address [1] 285390 0
Country [1] 285390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288677 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 288677 0
Private Bag 92019
Auckland 1010
New Zealand

Level 10
49 Symonds Street
Auckland 1010
Ethics committee country [1] 288677 0
New Zealand
Date submitted for ethics approval [1] 288677 0
19/11/2012
Approval date [1] 288677 0
05/02/2013
Ethics approval number [1] 288677 0

Summary
Brief summary
The aim of the study is to determine whether a smartphone application is a useful tool to help patients with HIV remember and manage their medications. Specifically, we intend to compare the effectiveness of two smartphone apps with different capabilities.

To do this, people who are currently living with HIV, attending the Auckland City Hospital Infectious Diseases clinic and use a smartphone are being asked to participate in this study.

Participants will then be randomly allocated to one of two smartphone application groups. All participants will be asked to use their respective app for three months.

It is hypothesised that participants in both groups will become more adherent to their ART medication. Specifically, it is aniticipated that the smartphone application designed to enhance patients' understanding of their HIV infection will be more effective in improving/maintaining adherence to ART.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37226 0
Prof Keith Petrie
Address 37226 0
Private Bag 92019
Auckland 1010
New Zealand

OR

Room 12.003
Level 12
Hospital Support Building
Auckland City Hospital
Auckland 1148
Country 37226 0
New Zealand
Phone 37226 0
+64 9 373 7599 extn 86564
Fax 37226 0
Email 37226 0
kj.petrie@auckland.ac.nz
Contact person for public queries
Name 37227 0
Prof Keith Petrie
Address 37227 0
Private Bag 92019
Auckland 1010
New Zealand

OR

Room 12.003
Level 12
Hospital Support Building
Auckland City Hospital
Auckland 1148
Country 37227 0
New Zealand
Phone 37227 0
+64 9 373 7599 extn 86564
Fax 37227 0
Email 37227 0
kj.petrie@auckland.ac.nz
Contact person for scientific queries
Name 37228 0
Prof Keith Petrie
Address 37228 0
Private Bag 92019
Auckland 1010
New Zealand

OR

Room 12.003
Level 12
Hospital Support Building
Auckland City Hospital
Auckland 1148
Country 37228 0
New Zealand
Phone 37228 0
+64 9 373 7599 extn 86564
Fax 37228 0
Email 37228 0
kj.petrie@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary