Results from ANRS 12249 TasP show that there is good take-up of the offer of repeated HIV screening at home in a rural South African population strongly affected by HIV infection. Immediate implementation of antiretroviral treatment of people managed in the healthcare system, following discovery of seropositivity, controls the infection. However, entry into the healthcare system of people diagnosed as HIV seropositive is too infrequent and slow to reduce HIV transmission in the population. The results of this randomized trial will be presented in an oral communication by Professor François Dabis (Université de Bordeaux, Inserm U1219) at AIDS 2016 in Durban, South Africa (18 to 22 July 2016).
Does initiation of triple antiretroviral therapy as soon as seropositivity is diagnosed reduce HIV transmission in the population and hence also new infections (the incidence)? This is a crucial question if we are to fight the HIV pandemic effectively. ANRS 12249 TasP is one of 5 international randomized trials currently underway that are seeking to assess the effectiveness of the universal test and treat strategy in reducing HIV transmission in strongly affected populations. It was conducted in South Africa in the Hlabisa sub-district of the rural region of KwaZulu-Natal, which has the highest prevalence of HIV infection in South Africa (29%) and one of the highest in the world. The final results of this trial are presented in an oral communication by Professor François Dabis (Université de Bordeaux, Inserm U1219) at AIDS 2016 in Durban, South Africa (18 to 22 July 2016).
In this trial, 22 geographic zones, or clusters, each of about 1280 people aged 16 or over, were defined. The clusters were distributed randomly into two equal groups (an intervention group and a control group). Overall, between March 2012 and April 2016, 13 239 people were included in the intervention arm and 14 916 in the control arm. Participants were repeatedly (every 6 months) offered rapid HIV screening in their homes. In the intervention group, people identified as seropositive were offered immediate antiretroviral therapy, whatever their CD4 count. In the control group, treatment was initiated according to the indications recommended by the South African Ministry of Health (originally a CD4 count <350 mm3; since January 2015 a CD4 count <500 mm3). Mobile treatment centers were sent to each cluster to facilitate access to care for people diagnosed as seropositive. Such people could also use local health services at any time.
The results show that:
- Screening at home is very well accepted since HIV status was identified at least once for 88% of the people contacted.
- 37.5% of the people diagnosed as HIV seropositive went to a treatment center in the 6 months after screening. Three months after the start of management by a healthcare center, 91% of people in the intervention group and 52% in the control group started antiretroviral therapy.
- Taking into account all available data sources (mobile and fixed treatment centers), the researchers estimated that only 4 out of 10 seropositive people living in the region had an undetectable viral load. Yet UNAIDS estimates that to meet its targets designed to end the epidemic by 2030, 7 out of 10 seropositive people must have an undetectable viral load by 2020 (90-90-90 target) .
- Lastly, 495 people became seropositive during the trial. The annual incidence of HIV infection was an estimated 2.13% (2.13 individuals infected out of 100 in a year) in the intervention group and 2.27% in the control group (adjusted relative risk: 0.96 [0.83 to 1.10]), figures that are not statistically different.
ANRS 12249 TasP is the first of 5 ongoing trials to yield data on the effect of the universal test and treat strategy within a population. Despite unquestionable advantages (excellent acceptance of repeated screening at home, very good response to antiretroviral therapy among seropositive people who decide to start it), the major challenge for people diagnosed as seropositive is to enter the healthcare system. Deenan Pillay and François Dabis, the principal investigators of the trial, consider that "This point is primordial for South Africa, where a national "treatment for all" program is being rolled out. Innovative research on the healthcare system and communities must be conducted to reach the targets of the universal test and treat strategy, if we hope one day to control the epidemic."
ANRS 12249 TasP was coordinated by Professor François Dabis, Professor Marie-Louise Newell (University of Southampton, United Kingdom) and Professor Deenan Pillay (Director of the Africa Centre for Health and Population Studies, Somkhele, South Africa, and University College London, United Kingdom). The trial was performed in partnership with the Ministry of Health of KwaZulu Natal, South Africa. Funding was provided by ANRS (France REcherche Nord&sud Sida-hiv Hépatites), GTZ (German Agency for Technical Cooperation), the Bill & Melinda Gates Foundation, the International Initiative for Impact Evaluation (3ie), and the Wellcome Trust (United Kingdom). The trial was conducted with support from Merck & Co. Inc, and Gilead Sciences, which provided Atripla®.
Founded in 1988, the French Research Agency ANRS brings together researchers from different fields and institutions in the developed world and resource-limited countries to work on scientific questions regarding HIV/AIDS or viral hepatitis. The ANRS funds research projects approved by international expert committees. It oversees projects from conception to completion and ensures that the results are used for the benefit of the populations concerned. Its annual budget of around 45 million euros is provided by the ministries in charge of Research and Health. Since 2012 it has been an autonomous agency of Inserm (French National Institute of Health and Medical Research).
The impact of universal test and treat on HIV incidence in a rural South African population. ANRS 12249 TasP trial, 2012-2016.
C. Iwuji1,2, J. Orne-Gliemann3, E. Balestre3, J. Larmarange4, R. Thiebaut3, F. Tanser1,5, N. Okesola1, T. Makowa1, J. Dreyer1, K. Herbst1, N. McGrath1,2,6, T. Barnighausen1,7, S. Boyer8,9, T. De Oliveira1, C. Rekacewicz10, B. Bazin10, M.-L. Newell11, D. Pillay1,12, F. Dabis3, for the ANRS 12249 TasP Study Group
1Africa Centre for Population Studies, Somkhele, South Africa, 2University College London, Research Department of Infection and Population Health, London, United Kingdom, 3Universite de Bordeaux, INSERM U1219 Bordeaux Population Health, Bordeaux, France, 4IRD, Centre Population & Développement (UMR 196 Paris Descartes IRD), Paris, France, 5University of KwaZulu-Natal, School of Nursing and Public Health, Durban, South Africa, 6University of Southampton, Faculty of Medicine and Faculty of Human, Social and Mathematical Sciences, Southampton, United Kingdom, 7Harvard University, Department of Global Health & Population, Harvard School of Public Health, Boston, United States, 8INSERM, UMR912 (SESSTIM), Marseille, France, 9Université Aix Marseille, UMR S_912, IRD, Marseille, France, 10Agence Nationale de Recherches sur le Sida et les hépatites virales, Paris, France, 11University of Southampton, Faculty of Medicine and Global Health Research Institute, Southampton, United Kingdom, 12University College London, Faculty of Medical Sciences, London, United Kingdom
Durban: François Dabis
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