Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study.

Background: Pre-exposure prophylaxis (PrEP) is the use of HIV anti-retroviral therapy to prevent HIV transmission in people at high risk of HIV acquisition. PrEP is highly efficacious when taken either daily, or in an on-demand schedule. In Australia co-formulated tenofovir-emtricitabine is registered for daily use for PrEP, however, this co-formulation is not listed yet on the national subsidized medicines list. We describe a study protocol that aims to demonstrate if the provision of PrEP to up to 3800 individuals at risk of HIV in Victoria, Australia reduces HIV incidence locally by 25% generally and 30% among GBM. Methods: PrEPX is a population level intervention study in Victoria, Australia in which generic PrEP will be delivered to 3800 individuals for up to 36 months. Study eligibility is consistent with the recently updated 2017 Australian PrEP guidelines. Participants will attend study clinics, shared care clinics, or outreach clinics for quarterly HIV/STI screening, biannual renal function tests and other clinical care as required. Study visits and STI diagnoses will be recorded electronically through the ACCESS surveillance system. At each study visit participants will be invited to complete behavioral surveys that collect demographics and sexual risk data. Diagnosis and behavioral data will be compared between PrEPX participants and other individuals testing within the ACCESS surveillance system. A subset of participants will complete in depth surveys and interviews to collect attitudes, beliefs and acceptability data. Participating clinics will provide clinic level data on implementation and management of PrEPX participants. The population level impact on HIV incidence will be assessed using Victorian HIV notification data. Discussion: This study will collect evidence on the real world impact of delivery of PrEP to 3800 individuals at risk of acquiring HIV in Victoria. This study will provide important information for the broader implementation of PrEP planning upon listing of the tenofovir-emtricitabine on the national subsidized list of medicines. The study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001215415).

Re-Wired: treatment and peer support for men who have sex with men who use methamphetamine.

Background This paper examines a methamphetamine treatment and peer support program for gay men and other men who have sex with men (MSM) who use methamphetamine. Australian MSM use illicit drugs including methamphetamine at significantly higher rates than the broader community.1,2 Methamphetamine rates are higher again amongst HIV positive MSM. Methamphetamine in the MSM community is associated with sexual activity and may be associated with psychosocial harms including risk of the transmission of HIV and sexually transmissible infections.3,4,7,8 Methods: This paper presents the formal evaluation of Re-Wired, Australia's first structured methamphetamine treatment and support program for MSM, consisting of a free, six week therapeutic group and Re-Wired 2.0, a follow up peer support group. Data collection included baseline and post intervention administration of the Kessler Scale of Psychological Distress (K10) and the Drug Use Disorders Identification Test (DUDIT), the Personal Wellbeing Index (PWI) and the Readiness to Change Questionnaire (RCQ). This was complemented with qualitative session feedback and a small number of post intervention participant interviews. RESULTS: Program evaluation demonstrated modest improvements in participant psychological distress, personal well-being and stage of change and reductions in methamphetamine use post intervention. Qualitative data revealed benefits of a specialised harm reduction intervention for this population through addressing fear of discrimination and stigma. CONCLUSIONS: The presented harm reduction program for MSM who use methamphetamine demonstrates the potential for a specialist peer-based approach to reduce harm in this vulnerable population. This approach may be suitable for adaptation with MSM populations in similar high-income settings.