Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001361695
Ethics application status
Approved
Date submitted
8/12/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of online media on the awareness and uptake of pre-exposure prophylaxis among Asian-born men who have sex with men in Australia
Scientific title
The impact of online media on the awareness and uptake of pre-exposure prophylaxis among Asian-born men who have sex with men in Australia: An open-two arm pilot randomised controlled trial
Secondary ID [1] 311113 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV prevention 332268 0
Condition category
Condition code
Infection 328983 328983 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After potential participants see the trial ads, they can click on the link or scan the QR code that links to the trial information and consent online page, where participants will be provided with information about eligibility, the trial process and compensation, and instructions to complete the trial. After participants consent to participate in the trial, they will answer questions to confirm their eligibility. Once Qualtrics confirms that they are eligible, they will enter the trial. In the first part of the trial, participants will answer questions regarding their demographic characteristics, contact information including an email address and phone number, questionnaires related to HIV- and PrEP knowledge, attitudes toward PrEP and intention-to-use PrEP. Subsequently, they will be randomised to receive either the audio drama or written information page (Pan.org.au). The survey platform (Qualtrics) will randomly assign participants to either arm. In the intervention arm, participants will watch the audio drama developed by the local community for this study. The audio drama is composed of six episodes of an audio drama (podcast style). The length of each episode is about 3-5 minutes, and the total length is about 20-30 minutes. The audio drama’s script is written by the Asian-born MSM living in Australia with the assistance of scriptwriters and then reviewed by the research team. There are three main queer Asian-born MSM characters, including a newly-arrived MSM who is a naïve pre-exposure prophylaxis for HIV (PrEP) user, an experienced PrEP user who is vulnerable to HIV infection and an experienced PrEP user who is at low risk of HIV infection. The audio drama, which was designed by community members to tackle common misconceptions and barriers to PrEP implementation in this group, will show self-growth within the newly-arrived MSM to increase relatability to Asian-born MSM who come to Australia while delivering health messages to the audience in a fun and easy-to-follow manner. Examples of the health messages are ‘enjoy safe sex, get PrEP’ and ‘PrEP is for everyone, being on PrEP doesn’t mean saying goodbye to your culture’.
Participants have the flexibility to consume the drama at their own discretion and they can leave the survey, return, continue watching the audio drama and finish this survey within the next 2 weeks by simply reopening the same link in the same browser. We will track how many episodes participants complete. We will track the total time participants spend to finish watching each episodes. They should spend between 2 to 10 minutes for watching each episode of the audio drama.
Intervention code [1] 327563 0
Prevention
Comparator / control treatment
Participants in this arm will receive links to read PrEP-related information on PAN.org.au, which is the common approach suggested by clinicians in Victoria to gain PrEP-related information. Participant will click five links on the survey to read five articles on PAN.org.au. Those articles includes how to initiate, purchase and use PrEP in Australia, with or without Medicare.

Participants have the flexibility to read the article at their own discretion and they can leave the survey, return, continue reading the articles and finish this survey within the next 2 weeks by simply reopening the same link in the same browser. We will track how many episodes/articles participants complete. We will track the total time participants spend to finish reading all pages. The time from the first click and last click should be between 10-20 minutes for reading the PAN website.
Control group
Active

Outcomes
Primary outcome [1] 336777 0
Acceptability of online media
Timepoint [1] 336777 0
Baseline- immediately after they finished watching the audio drama or reading the articles.
Primary outcome [2] 336778 0
Engagement towards online media
Timepoint [2] 336778 0
Baseline- immediately after they finished watching the audio drama or reading the articles.
Primary outcome [3] 336779 0
Intention-to-use and attitudes toward PrEP
Timepoint [3] 336779 0
Baseline- right before and immediately after they finished watching the audio drama or reading the articles.
Secondary outcome [1] 429656 0
Uptake of PrEP at one- and two-month after the intervention/control
Timepoint [1] 429656 0
one and two months after receiving the intervention/control
Secondary outcome [2] 429657 0
Adherence to PrEP (if participants initiate PrEP after receiving the intervention/control)
Timepoint [2] 429657 0
one and two months after receiving the intervention/control
Secondary outcome [3] 429658 0
Knowledge of PrEP
Timepoint [3] 429658 0
Baseline- right before and immediately after they finished watching the audio drama or reading the articles.
Secondary outcome [4] 430260 0
(Primary outcome) Attitudes toward PrEP
Timepoint [4] 430260 0
Baseline- right before and immediately after they finished watching the audio drama or reading the articles.

Eligibility
Key inclusion criteria
1 Self-identify as gay, bisexual men, queers or other men who have sex with men
2 Born in countries in Southeast-, East- and South Asia
3 At least 18 years old at the time of recruitment
4 No prior HIV diagnosis or a positive HIV test result (Unknown is acceptable)
5 Never used on-demand or daily HIV PrEP
6 Sufficient English to provide informed consent
7 Willing to consent to the study
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1 Ever used on-demand or daily HIV PrEP
2 Prior HIV diagnosis
3 Born in countries other than Southeast-, East- and South Asian countries
4 Self-identify as women, transgender men or women

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)
Participants will be randomised using a randomiser integrated within Qualtrics, which is a web-based online management service. Allocation concealment will be ensured, as the service will not release the randomisation code until the respondent has been recruited into the trial, which takes place after the respondents’ eligibility has been confirmed and all baseline measurements have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either the intervention or control arm, with a 1:1 allocation as per a Qualtrics-generated randomisation. Stratification will be performed based on length of stay in Australia, with participants being stratified into newly-arrived MSM (<=4 years) and long-term stay MSM (> 4 years).
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 315371 0
Government body
Name [1] 315371 0
National Health and Medical Research Council
Country [1] 315371 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jason J. Ong
Address
Melbourne Sexual Health Centre, Central Clinical School, Monash University, 580 Swanston st, Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 317431 0
None
Name [1] 317431 0
Address [1] 317431 0
Country [1] 317431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314288 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 314288 0
Ethics committee country [1] 314288 0
Australia
Date submitted for ethics approval [1] 314288 0
24/10/2023
Approval date [1] 314288 0
30/11/2023
Ethics approval number [1] 314288 0
685/23

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

Contacts
Principal investigator
Name 131070 0
A/Prof Jason J. Ong
Address 131070 0
Melbourne Sexual Health Centre, Central Clinical School Monash University, 580 Swanston st, Carlton VIC 3053
Country 131070 0
Australia
Phone 131070 0
+61 401660753
Fax 131070 0
Email 131070 0
[email protected]
Contact person for public queries
Name 131071 0
Jason J. Ong
Address 131071 0
Melbourne Sexual Health Centre, Central Clinical School Monash University, 580 Swanston st, Carlton VIC 3053
Country 131071 0
Australia
Phone 131071 0
+61 401660753
Fax 131071 0
Email 131071 0
[email protected]
Contact person for scientific queries
Name 131072 0
Jason J. Ong
Address 131072 0
Melbourne Sexual Health Centre, Central Clinical School Monash University, 580 Swanston st, Carlton VIC 3053
Country 131072 0
Australia
Phone 131072 0
+61 401660753
Fax 131072 0
Email 131072 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


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.