A longitudinal cohort study of HIV ‘treatment as prevention’ in gay, bisexual and other men who have sex with men: the Treatment with Antiretrovirals and their Impact on Positive And Negative men (TAIPAN) study protocol

Abstract

BackgroundAustralia has increased coverage of antiretroviral treatment (ART) over the past decade, reaching 73% uptake in 2014. While ART reduces AIDS-related deaths, accumulating evidence suggests that it could also bolster prevention efforts by reducing the risk of HIV transmission (‘treatment as prevention’). While promising, evidence of community-level impact of treatment as prevention on reducing HIV incidence among gay and bisexual men is limited. We describe a study protocol that aims to determine if scale up of testing and treatment for HIV leads to a reduction in community viraemia and, in turn, if this reduction is temporally associated with a reduction in HIV incidence among gay and bisexual men in Australia’s two most populous states.MethodsOver the period 2009 to 2017, we will establish two cohorts making use of clinical and laboratory data electronically extracted retrospectively and prospectively from 73 health services and laboratories in the states of New South Wales and Victoria. The ‘positive cohort’ will consist of approximately 13,000 gay and bisexual men (>90% of all people living with HIV). The ‘negative cohort’ will consist of at least 40,000 HIV-negative gay and bisexual men (approximately half of the total population). Within the negative cohort we will use standard repeat-testing methods to calculate annual HIV incidence. Community prevalence of viraemia will be defined as the proportion of men with a viral load ≥200RNA copies/mm3, which will combine viral load data from the positive cohort and viraemia estimates among those with an undiagnosed HIV infection. Using regression analyses and adjusting for behavioural and demographic factors associated with infection, we will assess the temporal association between the community prevalence of viraemia and the incidence of HIV infection. Further analyses will make use of these cohorts to assess incidence and predictors of treatment initiation, repeat HIV testing, and viral suppression.DiscussionThis study will provide important information on whether ‘treatment as prevention’ is associated with a reduction in HIV incidence at a community level among gay and bisexual men.

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial

“…A software program called GRHANITE is used to extract the data. The software was specifically developed to link primary care and hospital data without any personal information leaving the clinic and the tool is used in the ACCESS project [ 28 ], to extract and link data from primary care clinics, hospitals and laboratories [ 38 ]. Using GHRANITE, data are stripped of any identifying information before leaving the clinical site but can be linked by the scrambled client ID generated by the GHRANITE tool.…”

Getting Real on U=U: Human Rights and Gender as Critical Frameworks for Action

“…For example, the removal of upfront copayments for treatment or providing access to free ART to all people living with HIV can radically enhance access to the means of achieving an undetectable viral load. 22 …”

Monitoring the Control of Sexually Transmissible Infections and Blood-Borne Viruses: Protocol for the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS)

“…Beyond this work, ACCESS is being used increasingly to support other forms of research and evaluation. In some projects, ACCESS provides line-listed and deidentified datasets, which are and have been used to conduct a large-scale study of HIV treatment-as-prevention [28], evaluate pre-exposure prophylaxis implementation trials [29,30], and study Victoria’s hepatitis C elimination response [31]. In other cases, as in the evaluation of HIV control in New South Wales [32], ACCESS has routinely provided specifically designed indicators (eg, HIV testing uptake and rates of viral suppression) to monitor and evaluate various aspects of BBV prevention and management.…”