Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001755123
Ethics application status
Approved
Date submitted
4/12/2019
Date registered
10/12/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using behavioural economics to improve testing for HIV and other sexually transmitted infections among men who have sex with men
Scientific title
Using behavioural economics to improve testing for HIV and other sexually transmitted infections among men who have sex with men
Secondary ID [1] 300006 0
none
Universal Trial Number (UTN)
U1111-1244-9478
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human immunodeficiency virus (HIV) 315491 0
sexually transmitted infection 315492 0
Condition category
Condition code
Infection 313778 313778 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Infection 313779 313779 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reframing the content of SMS message to remind someone to get tested for HIV or other sexually transmitted infections (STIs).
Participants will receive a SMS message e.g. Positive frame: "To stay healthy, regular testing is recommended. Phone for an appointment"; Negative frame: "Not testing regularly might harm your health. Phone for an appointment"; Social norm frame: "The majority of people receiving this message will attend for STI. Phone for an appointment". This message will be administered according to the client's predetermined frequency of reminders (i.e. every 3 or 6 or 12 months). Melbourne Sexual Health Centre (MSHC) will send out the SMS. We will monitor whether clients are returning to MSHC within a month of receiving the message. If clients don't return to MSHC, they will receive a short SMS to see if they tested for STIs elsewhere.

The framing of the message will be changed every month - so all individuals scheduled to receive a reminder in that month will receive that framed message. We will run the trial over 6 months with rotating messages (e.g. month 1 = social norm, month 2 = positive framing, month 3 = negative framing, month 4 = social norm, month 5 = positive framing, month 6 = negative framing).
Intervention code [1] 316273 0
Early detection / Screening
Comparator / control treatment
Historical control group who have received traditional reminder SMS message (i.e. neutral frame: "Your next check-up is now due. Phone for an appointment") using Melbourne Sexual Health Centre records from Oct 2018 to October 2019.
Control group
Historical

Outcomes
Primary outcome [1] 322191 0
Testing for HIV/STI within one month of receiving the SMS message.
This will be through an audit of our clinic's medical record system to see if the person had re-attended for an STI test.
Timepoint [1] 322191 0
Within one month post-reminder.
Secondary outcome [1] 377633 0
HIV and/or STI positivity rate (composite outcome)
Audit of medical records
Timepoint [1] 377633 0
within 1 month of receiving SMS reminder
Secondary outcome [2] 377794 0
HIV positivity rate
Audit of medical records
Timepoint [2] 377794 0
within 1 month of receiving the SMS reminder
Secondary outcome [3] 377795 0
STI positivity rate (i.e. chlamydia or gonorrhoea or syphilis or mycoplasma genitalium or lymphogranuloma venereum or herpes)
Each STI will be evaluated separately.
Audit of medical records
Timepoint [3] 377795 0
within one month of SMS reminder

Eligibility
Key inclusion criteria
Men who have sex with men
age 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics to evaluate the proportion of men who were tested for STI/HIV following receipt of SMS message. Logistic regression models to identify factors associated with likelihood to test for STI/HIV e.g. age, educational level, location of residence, etc...

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
5/04/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
2000
Accrual to date
600
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304457 0
University
Name [1] 304457 0
Monash University
Country [1] 304457 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 304727 0
None
Name [1] 304727 0
none
Address [1] 304727 0
none
Country [1] 304727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304892 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 304892 0
Ethics committee country [1] 304892 0
Australia
Date submitted for ethics approval [1] 304892 0
05/11/2019
Approval date [1] 304892 0
11/11/2019
Ethics approval number [1] 304892 0
703/19

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

Contacts
Principal investigator
Name 98550 0
A/Prof Jason Ong
Address 98550 0
Melbourne Sexual Health Centre
580 Swanston Street, Carlton Victoria 3053
Country 98550 0
Australia
Phone 98550 0
+61 393416263
Fax 98550 0
Email 98550 0
[email protected]
Contact person for public queries
Name 98551 0
Jason Ong
Address 98551 0
Melbourne Sexual Health Centre
580 Swanston Street, Carlton Victoria 3053
Country 98551 0
Australia
Phone 98551 0
+61 393416263
Fax 98551 0
Email 98551 0
[email protected]
Contact person for scientific queries
Name 98552 0
Jason Ong
Address 98552 0
Melbourne Sexual Health Centre
580 Swanston Street, Carlton Victoria 3053
Country 98552 0
Australia
Phone 98552 0
+61 393416263
Fax 98552 0
Email 98552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will provide aggregate/summary results to avoid identifying clients of our clinic.


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.