How PopART will be carried out
Starting in 2012, the trial will take place in 24 communities in Zambia and South Africa, with a total population of over 1 million. These 24 communities will be split into 3 groups, or arms:
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- Eight communities will receive the full PopART intervention
- Eight control communities will receive current standard of care.
- Eight communities will receive an intermediate intervention which includes all the components of PopART except that anti-retroviral therapy (ART) will be given according to current national guidelines.
This three-arm design will allow the trial to measure the extra effect of treating patients immediately rather than waiting until their immune function has deteriorated. A total of 60,000 adults from the communities will be followed up for two years to measure the impact of the interventions on new HIV infections.
Strategy evaluation and cost effectiveness
Building on previous clinical trials
PopART builds on two previous HPTN trials. Project Accept (HPTN 043) found that adding community mobilisation and support services to a mobile HIV counselling and testing programme can improve rates of testing in rural communities. HPTN 052 was the first randomised trial to show that treating an HIV-infected individual with ART reduces the risk of sexual transmission of HIV to an uninfected partner.
The first PopART concept followed the completion of a large international trial, called SPARTAC, led by Professor Jonathan Weber at Imperial. SPARTAC looked at whether there are any benefits to giving an early short course ART in individuals recently infected with HIV. The results are due to be published in the near future. An extension of this idea to a population level effect of universal HIV test and treat was further explored by Professor Weber and his group and has led to the development of PopART.