Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000364471p
Ethics application status
Not yet submitted
Date submitted
8/04/2025
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Same-Day Pre-exposure Prophylaxis for HIV on the Uptake of Pre-exposure Prophylaxis Among Medicare-ineligible Men Who Have Sex with Men in Melbourne, Australia: An Open-label Two-arm Pilot Randomised Controlled Trial (PrEP STAT Trial)
Scientific title
Impact of Same-Day Pre-exposure Prophylaxis for HIV on the Uptake of PrEP Among Medicare-ineligible Men Who Have Sex with Men in Melbourne, Australia: An Open-label Two-arm Pilot Randomised Controlled Trial
Secondary ID [1] 314164 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PrEP STAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV infection 336997 0
HIV prevention 336998 0
Condition category
Condition code
Infection 333464 333464 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PrEP STAT pack was co-designed through a collaborative process involving overseas-born MSM, graphic designers, researchers, and clinicians during a two-day ‘PrEP STAT’ Nudgeathon at the Alfred Centre, Melbourne, Australia. Four teams, each consisting of five clients, competed to design the most impactful, innovative, and feasible PrEP STAT pack. The winning design was decided by HIV experts and community leaders and was further refined with input from community members, clinicians and researchers. This intervention integrates a ‘Nudge’ approach to promote PrEP uptake and a ‘Pay-It-Forward’ model to encourage PrEP users to share the opportunity within their community, ensuring program sustainability. Nudges could be messages or pictures. Clients will self-reported their adherence to PrEP in the follow-up surveys.

The PrEP STAT pack includes a free 30-day supply of daily oral PrEP (Tenofovir disoproxil fumarate 300 mg and Emtricitabine 200 mg), a prescription for a 60-day supply of daily oral PrEP, self-care products (i.e., body wipe), a postcard featuring 'nudging' messages from previous PrEP users, and a personalised QR code linking to the ‘Pay-It-Forward’ electronic hub (e-hub). The pack is presented in a tote bag with the nudge message ‘Peace of Mind.’ Clients will receive a free PrEP STArTer (PrEP STAT) pack without requiring a confirmed negative HIV test result on the first consultation day, facilitating same-day PrEP initiation. The HIV test result will be available within 24 hours.

The Pay-it-forward e-hub provides access to a donation platform, trial information, and a ‘Love Letters to You’ platform, where clients can view and share messages encouraging others in the community to start PrEP. Messages from donors will be displayed on the e-hub’s main page to foster a sense of community support. Additionally, a link to MSHC’s trial information page will be included to enhance the credibility of the trial. Using a personalised QR code will help us track clients’ engagement with the pay-it-forward system and whether they make a donation.
Intervention code [1] 330763 0
Prevention
Comparator / control treatment
Clients will receive conventional PrEP initiation care. The process includes 1) attending the MSHC to undertake an HIV test, 2) receiving a prescription for a 90-day supply of daily oral PrEP (Tenofovir disoproxil fumarate 300 mg and Emtricitabine 200 mg) with a PrEP initiation info sheet, and 3) purchasing PrEP at a pharmacy or online pharmacy. Clients will self-reported their adherence to PrEP in the follow-up surveys. They will also receive a follow-up email with a personalised QR code to access the donation system at MSHC but not the Pay-it-Forward e-hub. Using a personalised QR code will help us track whether clients make a donation. The donation in the control arm will contribute to MSHC’s medical equipment and facilities.
Control group
Active

Outcomes
Primary outcome [1] 341036 0
Pre-exposure prophylaxis initiation
Timepoint [1] 341036 0
30-day and 90-day post intervention
Secondary outcome [1] 445887 0
Retention in PrEP care
Timepoint [1] 445887 0
30-day and 90-day post intervention
Secondary outcome [2] 445888 0
Harms
Timepoint [2] 445888 0
30-day and 90-day post intervention
Secondary outcome [3] 445889 0
Engagement in the donation system
Timepoint [3] 445889 0
90 day-post-intervention
Secondary outcome [4] 445890 0
Satisfaction
Timepoint [4] 445890 0
30 day post intervetion
Secondary outcome [5] 445892 0
Barriers and facilitators to PrEP initiation, continuation and discontinuation
Timepoint [5] 445892 0
within one month after the 90-day follow-up survey
Secondary outcome [6] 445894 0
Resource use
Timepoint [6] 445894 0
after the 90-day post follow up survey

Eligibility
Key inclusion criteria
1. Self-identify as gay or bisexual men, queers or other men who have sex with men
2. No access to Medicare
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, Suitable for PrEP according to the Australasian Society for HIV, Viral Hepatitis, and Sexual Health Medicine (ASHM) PrEP guideline
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. Self-identify as cisgender women
2. Whose blood cannot be drawn for laboratory testing
3. Suitable for PEP according to the Australasian Society for HIV, Viral Hepatitis, and Sexual Health Medicine (ASHM) PrEP guideline
4. Show signs or symptoms of acute HIV seroconversion illness and sexual history indicating possible acute HIV infection
5. Self-reported a history of renal diseases or associated conditions (e.g., hypertension,
diabetes)
6. Do not have contact should laboratory tests indicate a need to discontinue PrEP (e.g., HIV infection, unanticipated renal dysfunction)

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)
Clients 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)
After clients provide consent via the registration link, clients will be randomly assigned to either the intervention or control arm, with a 1:1 allocation as per Qualtrics-generated randomisation. Stratification will be performed based on length of stay in Australia, with clients being stratified into newly-arrived MSM ( 4 years).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
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
1/06/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27731 0
Melbourne Sexual Health Centre (MSHC) - Carlton
Recruitment postcode(s) [1] 43920 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 318676 0
Charities/Societies/Foundations
Name [1] 318676 0
John Marriott Trust for HIV
Country [1] 318676 0
Australia
Primary sponsor type
University
Name
Monash
Address
Country
Australia
Secondary sponsor category [1] 321103 0
None
Name [1] 321103 0
Address [1] 321103 0
Country [1] 321103 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317289 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317289 0
Ethics committee country [1] 317289 0
Australia
Date submitted for ethics approval [1] 317289 0
28/04/2025
Approval date [1] 317289 0
Ethics approval number [1] 317289 0

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

Contacts
Principal investigator
Name 140582 0
Prof Jason J Ong
Address 140582 0
Melbourne Sexual Health Centre, 580 Swanston st, Carlton, VIC, 2205
Country 140582 0
Australia
Phone 140582 0
+61 401660753
Fax 140582 0
Email 140582 0
[email protected]
Contact person for public queries
Name 140583 0
Warittha Tieosapjaroen
Address 140583 0
Melbourne Sexual Health Centre, 580 Swanston st, Carlton, VIC, 2205
Country 140583 0
Australia
Phone 140583 0
+61 466696328
Fax 140583 0
Email 140583 0
[email protected]
Contact person for scientific queries
Name 140584 0
Warittha Tieosapjaroen
Address 140584 0
Melbourne Sexual Health Centre, 580 Swanston st, Carlton, VIC, 2205
Country 140584 0
Australia
Phone 140584 0
+61 466696328
Fax 140584 0
Email 140584 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.