The first results of the pilot phase of the trial ANRS 12249 TasP show that the repeated offer of screening for HIV has been well accepted by a rural population in South Africa. The challenge remains of bringing infected individuals into health care facilities for treatment of the infection. These results were presented as an oral communication at the 20th International AIDS Conference organized by the International AIDS Society and held at Melbourne (Australia) from 20 to 25 July 2014.
Does initiation of triple antiretroviral therapy (ART) immediately after diagnosis of seropositivity reduce the transmission of HIV in the population and thereby also the acquisition of new infections (incidence)? This is a pivotal question in development of strategies to fight the HIV epidemic.
Launched in March 2012, the ANRS 12249 TasP (Treatment as Prevention) Trial is one of four international randomized trials designed to assess the efficacy of the TasP strategy in a large population. It is conducted the province of KwaZulu-Natal, South Africa, one of the highest prevalence areas in the world, and the highest in South Africa (16.9% in 2012 according to the latest national survey of the general population).
In this trial, 22 geographical zones (“clusters”), each of approximately 1000 inhabitants, were defined and randomly divided into two groups (an intervention group and a control group comprising 11 clusters). All inhabitants were routinely offering repeated (every six months) rapid HIV testing in their homes. In the intervention group, people found to be seropositive were offered immediate antiretroviral treatment, whatever their CD4 cell count. In the comparison group, treatment was offered according to currently recommended South African Department of Health guidelines. Mobile clinics worked in each cluster to expedite access to care.
Results from the pilot phase of the trial, were presented at the international HIV meeting in Melbourne. This pilot phase was conducted in 10 geographic clusters containing over 12,000 residents above 16 years of age, and followed up for between 12 and 18 months. HIV status was determined in close to 9,000 of these individuals, either because they reported that they were seropositive or because they agreed to rapid HIV testing.
The initial findings are as follows:
HIV status was determined for 82% of those contacted, meaning that home-based testing was acceptable to this population. Among people who were found to be seronegative at the first home-based contact, 85% agreed to a second HIV test at the next home visit.
– Scientists also found a prevalence of HIV infection of 31%, much higher than the initial estimate.
– Around 25% of the 2,570 HIV infected individuals learned of their HIV status through the study.
– In respect to those diagnosed with HIV infected individuals and not already receiving therapy only 48% presented to a clinic within six months. 63% were linked within a year.
– In the intervention group, 80% of those with CD4 >350 cells/mm3 received therapy.
“These initial results are very important,” pointed out Professor François Dabis (Institut de Santé Publique, Epidémiologie et Développement, Inserm U 897, Bordeaux), one of the co-investigators of the trial, “because they validate the feasibility of the TasP strategy, which aims to test and treat the whole adult population so as to curb transmission. Rapid home-based HIV testing is very well accepted and we observed no major hindrance likely to call the intervention into question. We noted simply that people newly diagnosed as seropositive need time to engage with care, notably when they feel in good health. However, once in care, ART uptake is good. We are enhancing our strategies to encourage linkage and retention in care for all trial participants”.
“Validation of phase I of this trial is essential,” explained Professor Jean-François Delfraissy, Director of ANRS (France REcherche Nord&sud Sida-hiv Hépatites). “We can therefore pursue the trial.” The study entered its second phase in June 2014. The first results on the effect of TasP on the incidence of HIV infection in the population should be known by the end of 2016.
The ANRS 12249 TasP Trial is coordinated by Professor François Dabis, Professor Marie-Louise Newell (University of Southampton, United Kingdom) and Professor Deenan Pillay (Director of the Africa Center for Health and Population Studies, Mtubatuba, South Africa, and University College London, United Kingdom). The trial is run in partnership with the Department of Health, KwaZulu Natal, South Africa, GTZ (German government agency operating in the field of technical cooperation) and the Wellcome Trust (United Kingdom). The International Initiative for Impact Evaluation (3ie) is providing funding for the second phase of the study.