None listed
Conditions
Brief summary
PrEP STAT is an open-label-two-arm RCT designed to evaluate the uptake of PrEP where Medicare-ineligible MSM receive the intervention—the free PrEP STAT pack (Tenofovir disoproxil fumarate 300 mg and Emtricitabine 200 mg)— compared to those who receive the control —a prescription for PrEP with a PrEP initiation infosheet. Clients will receive either the intervention or control within their consultation at MSHC. This trial will be carried out between June and September 2025. The trial will be integrated into routine care, in which clinicians will be digitally notified (via a message on the client file) when eligible clients visit the centre. Participating clinicians will assess eligibility and invite eligible clients to participate in the PrEP STAT trial.
Interventions
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 resear
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.
Sponsors
Monash
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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)
Outcome results
None listed