Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000342415
Ethics application status
Approved
Date submitted
15/01/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Social network-based approaches to distributing HIV self-test kits among gay, bisexual and other men who have sex with men: A demonstration study
Scientific title
Assessing the effectiveness of Social network-based approaches to distributing HIV self-test kits among gay, bisexual and other men who have sex with men: A demonstration study
Secondary ID [1] 313710 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 336306 0
Condition category
Condition code
Infection 332839 332839 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 332838 332838 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Researchers will assess the eligibility of the interested participants and will follow up via email to make initial contact with the eligible participants. Eligible men who agree to participate will be given the Participant Information and Consent Form (PICF)-Test promoter version (see Appendix A1). If the participant has any queries about the study, they can contact the researchers (contact details on the PICF) before signing the consent form. Once participants (test promoters) have consented, they will receive an electronic copy of the Information Booklet and HIV self-test FAQ. Materials from the trial will be reviewed by the representatives (advisory support committee members) from the community organisations (i.e., Thorne habour health).

Each test promoter will then receive four HIV self-test kits via mail, one for himself/themselves to use and remaining three for him to distribute to his social network or sexual partners, preferably overseas-born MSM. Test promoters will be required to distribute the HIV self test kits to his social network or sexual partners within 3 months.

All kits shipped to a test promoter will be individually packed with instructions in an unmarked box to protect privacy. Within each packed HIV self-test kit box, there will receive a hardcopy of the Information Booklet with information on the study procedure and a HIV self-test FAQ (what is HIV self-test , how to perform a HIV self-test , how to handle a reactive result, what to do if the test is invalid), condoms and QR codes/links to survey. Each kit will be assigned with a unique “ST” number for returned results tracking (coded in a way that enables the study to track which results are returned by contacts of which test promoter).

When the test promoter receives the package, he/they will be required to send a text message (SMS) to the study researcher to confirm receipt of the package. The phone number will be obtained from one of Melbourne Sexual Health Centre’s current research phone numbers, and will be used exclusively for this study. Test promoters will receive a phone call from the researcher at approximately 1.5-2 weeks after the kit is mailed out from the study site if the researcher did not receive a text message from the test promoter.

When the test promoter distributes the package to their social contact, he/they will be required to send a second text message to the researcher with details of the ‘corresponding ST number’ and ‘country of birth of the social contact’ to inform the researcher that the kit has been distributed to a social contact. A follow-up phone call or text message will be made at 1 month, 2 months if the test promoter has not yet distributed the kits out.

The test-promoter is not required to provide additional consent to the social contact they provide the kit to. They are simply required to provide the kit to the individuals, and it is assumed that the test promoters know country of birth for identification purposes as they are friends or sexual partners.

After the social contacts of the test promoter opens the pack, he/they will be asked to a send a text message to the researcher with details of the ST number to inform the researcher that the kit is received and ‘activated’. In the scenario that the test promoter has distributed the test kit to his/their social contacts but the social contact has not conducted the test (i.e researcher did not receive activation SMS from social contact or post-test survey does not contain the ST number of the test kit that the social contact received), the researcher will follow-up with the test promoter at 1-month, 2-month and 3-month (from date of second SMS) to remind the test promoter to prompt his social contact to do the HIV self-test.

There will also be a QR code on the HIV self-test kit packaging which will bring them to the study website. This website will be created under the current Melbourne Sexual Health Centre research page (https://www.mshc.org.au/research/research-studies/HIVselftest). It will an interactive webpage with a video demonstration video on how to perform the self-test (Appendix A19- Atomo video transcript). At the bottom of the video, there will be a link to a survey. While they wait for their results (~15 minutes), they can click on the survey (~10-15 minutes) with questions on their ST number, demographic characteristics, HIV testing practices, who they received the test kit from, and their test result etc. We will also ask their experience of and attitude towards HIV self-test using open-ended comments and Likert scales. In the survey, we will also ask them if they are willing to be interviewed to share about their testing experiences (with reimbursement of $50 Coles voucher) as part of the qualitative aspect of the study.

At the end of the survey, participants will be asked if they wish to pay-it-forward and sign up as test promoters. If so, they will be redirected to another page to leave their contact details. This information will not be linked to their responses on the post-test survey. They will be assessed for eligibility and recruited as new test promoter if eligible. The researcher will contact them to obtain written consent (see Participant Information and Consent Form-- 2nd wave) to participate in the study. Each test promoter will receive another four HIV self-test kits (one for their next use and three kits to distribute to their overseas-born social networks).
Intervention code [1] 330308 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340374 0
Examine effectiveness of social-network approach in distributing HIV self-testing kits among men who have sex with men (MSM)
Timepoint [1] 340374 0
baseline, 3 month from signing the participant consent form.
Secondary outcome [1] 443899 0
assess the acceptability of social network approach in distributing HIV self-test kits.
Timepoint [1] 443899 0
3 months from start of study

Eligibility
Key inclusion criteria
- Self-identify as gay, bisexual men, queers or other men who have sex with men and
- Aged 18 years or above, and
- No prior HIV diagnosis or a positive HIV test result (Unknown is acceptable), and
- Speak and read English, and
- Able to provide their own consent, and
- Willing to comply with all requirements of the study
- Born in Australia or overseas
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Self-identify as women, transgender men or women
- Known to be living with HIV

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/11/2024
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
100
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318176 0
Government body
Name [1] 318176 0
NHMRC
Country [1] 318176 0
Australia
Primary sponsor type
Individual
Name
Dr Jason Ong, Melbourne Sexual Health Centre
Address
Country
Australia
Secondary sponsor category [1] 320940 0
None
Name [1] 320940 0
Address [1] 320940 0
Country [1] 320940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316827 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316827 0
Ethics committee country [1] 316827 0
Australia
Date submitted for ethics approval [1] 316827 0
12/07/2024
Approval date [1] 316827 0
08/08/2024
Ethics approval number [1] 316827 0

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

Contacts
Principal investigator
Name 139126 0
Prof Jason Ong
Address 139126 0
Melbourne Sexual Health Centre, 580 Swanston Street, Carlton VIC 3053
Country 139126 0
Australia
Phone 139126 0
+61 0401660753
Fax 139126 0
Email 139126 0
[email protected]
Contact person for public queries
Name 139127 0
Ying Zhang
Address 139127 0
Melboune Sexual Health Centre, 580 Swanston Street, Carlton VIC
Country 139127 0
Australia
Phone 139127 0
+61 0423140098
Fax 139127 0
Email 139127 0
[email protected]
Contact person for scientific queries
Name 139128 0
Ying Zhang
Address 139128 0
Melboune Sexual Health Centre, 580 Swanston Street, Carlton VIC
Country 139128 0
Australia
Phone 139128 0
+61 0423140098
Fax 139128 0
Email 139128 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.