In both trial arms, rounds of home-based HIV testing are repeated every six months.
All trial participants identified as HIV-infected are referred to a local Tas P trial clinic situated in the trial cluster in which they live.
We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods.
The UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4.
We then outline the research questions and objectives that each component of our multi-disciplinary research programme aims to address.
We describe in detail the research methods and specific data collection tools being implemented.The HIV prevalence in the sub-district is one of the highest in the world, with around 29% of adults infected with HIV .The UTT strategy being tested in the cluster-randomised Tas P trial has two main components (the trial intervention package): universal and repeat home-based HIV testing of all resident adults and immediate ART initiation.Finally we discuss some of the emerging issues raised by UTT strategies that are unlikely to be answered in the short-term by any of the ongoing trials.The protocol of the Tas P trial, registered on (NCT01509508), has been described elsewhere .And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services?The answers to these research questions will be critical for routine implementation of UTT strategies.In terms of linkage to care and ART initiation, a recent meta-analysis of sub-Saharan African data published between 20, showed that, for 100 patients with a positive HIV test, 72 had a CD4 count performed, 40 were eligible for ART and only 25 started .The 2013 World Health Organisation (WHO) guidelines on ART eligibility recommend initiation of ART at a CD4 count threshold of 500 cells/mm).A recent meta-analysis of home-based voluntary HIV testing in sub-Saharan Africa showed that the proportion of people who accept home-based HIV testing ranged from 58.1% to 99.8% overall (pooled percentage 83.3%), and from 58.1 to 91.8% in South Africa specifically .This review did not present data on repeat HIV testing, however the few available reports on uptake of consecutive HIV testing campaigns show a 75-80% uptake of a second test among those tested the first time [12,13].