A team of researchers from the London School of Hygiene and Tropical Medicines, Zambia AIDS Related Tuberculosis Project, Imperial College London and Stellenbosch University has been awarded $37 million to test an innovative combination of strategies to prevent HIV in African countries.
The project, called Population ART (PopART), would be led by Richard Hayes of the London School of Hygiene and Tropical Medicines and is expected to test the impact of a combination prevention strategy that combines community-wide house-to-house voluntary testing for HIV, offer of medical circumcision to men who test HIV-negative, and offer of immediate initiation of antiretroviral therapy (ART) for all those testing HIV-positive.
An estimated 33 million people worldwide are living with HIV. With 2.5 new infections for every HIV-positive patient commencing ART, current approaches to treatment and prevention are struggling to contain the spread of the infection.
Unless the incidence of HIV can be steeply reduced, forecasts show a continuously growing number of HIV-infected individuals so that by 2030 about $35 billion per year will be needed to deliver ART to HIV-positive patients in these resource-limited settings.
Combination prevention approaches like PopART may be initially more expensive than current approaches, but estimates suggested that if HIV incidence was not reduced significantly, the financial impact of an ever increasing number of patients in need of treatment and hospitalisation would be far greater.
Mathematical modelling of PopART has shown that the intervention should lead to a steep reduction in new HIV infections. A rigorously designed trial is now needed to test whether such interventions can be effectively implemented in resource-poor settings in Africa, and to measure the actual impact on HIV at population level.
Starting in 2012, the trial will be carried out in 24 communities in Zambia and South Africa, with a total population of over 1 million. Eight communities would be receiving the full PopART intervention while eight control communities would receive current standard of care. The remaining eight communities would receive an intermediate intervention which includes all the components of PopART except that ART would be given according to current national guidelines.
This three-arm design according to the researchers would 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 would be followed up for two years to measure the impact of the interventions on new HIV infections.
Data from the trial would be combined with cost data and projections from mathematical models to estimate the cost effectiveness of the intervention and alternative approaches.
Hayes, the lead researcher said “PopART is designed as a universal intervention offered to the entire community. We hope this will prevent stigmatisation of infected individuals and reduce the need for specially targeted interventions for specific risk groups.
“There is a strong rationale for the PopART approach, but we need a rigorously conducted study to determine how well the strategy can be delivered in practice, and what impact it has at population level.”
Peter Piot, the School’s Director and former Executive Director of UNAIDS, commenting on the project said: “I am delighted that this award has been made as it will enable the promising idea of combination prevention strategy to be tested on a large scale. This is one of the most important questions for AIDS research and policy today.”