MELBOURNE, Australia — A large-scale test-and-treat program appears to be feasible in rural South Africa, where rates of HIV are hyperendemic and the prevention of new infections is paramount, early research shows.
"We know that antiretroviral therapy can prevent sexual transmission in several different contexts, but we don't know yet whether we can really reduce the acquisition of HIV infection at a population level," François Dabis, MD, from INSERM in Bordeaux, France, said at a news conference here at the 20th International AIDS Conference.
"The best way to demonstrate scientifically that this universal test-and-treat hypothesis holds true is to conduct an experiment at the population level and go well beyond the use of antiretrovirals," Dr. Dabis said. "From what we have seen over the past 2 years, I can say that all indicators are very good, and we are now moving on to the full-scale trial."
Preliminary findings from the ANRS 12249 test-and-treat randomized trial were presented here at the meeting. The study is being carried out in the region of Kwazulu-Natal, an area covering 1430 km² in the subdistrict of Hlabisa, where 228,000 Zulu-speaking people reside. The prevalence rate of HIV in this region is reportedly 24%.
"In this rural district, we have identified 22 groups or clusters of about 1000 residents each," Dr. Dabis noted. The study team goes door to door and residents are offered HIV testing using dried blood spot technology. The offer of HIV home testing is repeated every 6 months.
"We then randomized 11 of these clusters to receive universal antiretrovirals. We offer all HIV-positive individuals immediate and universal treatment," Dr. Dabis explained.
Individuals in the remaining clusters, who will serve as the control group, will be offered antiretrovirals in accordance with South African guidelines (when CD4 cell counts fall to 350 copies/mL).
In the past 2 years, the team has managed to contact about 10,000 people living in the region. In 5 test-and-treat areas and 5 control areas, "the very good news is that 95% of people agreed to participate in our trial," Dr. Dabis noted.
During the first attempt at contact, more than 80% agreed to be tested for HIV in the home. "When we came back for the negatives 6 months later, 85% of this group again agreed to be tested, so we have very high acceptance rates for testing at home in these communities," he reported.
He emphasized that the use of antiretrovirals was already fairly widespread in these areas, so accepting treatment wasn't entirely new. For example, at the beginning of the project, approximately 40% of individuals in these regions who had already tested HIV-positive were receiving antiretrovirals.
After the team had diagnosed a case of HIV, initiation of therapy was not immediate, Dr. Dabis acknowledged. Only about one-third of those diagnosed by team members accepted treatment from the outset.
"In the year that followed, this increased to 48%," he said, which "means that linkage to care and treatment initiation is still incomplete, despite our efforts."
In contrast, when the team opened test-and-treat clinics no further than a 45-minute walk from the communities, treatment initiation "worked reasonably well," Dr. Dabis reported. "Everything we have observed in this very first phase of the project fits with our original assumptions."
"We are not at the stage where we can demonstrate that there is effectiveness of test and treat yet," Dr. Dabis noted. "Based on findings so far, the governing bodies and the sponsors of the trial have decided to move to full scale and, as of last month, we have started to open new clusters."
No one intervention will be enough to eliminate HIV, said Stefano Vella, MD, from the Istituto Superiore di Sanita in Rome. "We will need to have combined approaches; test and treat will be one, pre-exposure prophylaxis another," he told Medscape Medical News.
"While we won't have results from this trial for years," Dr. Vella added, "data on the feasibility of this approach, which is now being tested in a number of different clinical trials, is still very important."
The trial is sponsored by ARNS, a French agency, and is funded by a variety of sources, including the Bill & Melinda Gates Foundation. Dr. Dabis and Dr. Vella have disclosed no relevant financial relationships.
20th International AIDS Conference: Abstract WEAC0105LB. Presented July 23, 2014.
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Cite this: Large-Scale HIV Test-and-Treat Strategy Viable - Medscape - Aug 01, 2014.