HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.
<h4>Background</h4>The HPTN 052 trial confirmed that antiretroviral therapy (ART) can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial ai...
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Public Library of Science (PLoS)
2014-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0084511 |
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| author | Anne Cori Helen Ayles Nulda Beyers Ab Schaap Sian Floyd Kalpana Sabapathy Jeffrey W Eaton Katharina Hauck Peter Smith Sam Griffith Ayana Moore Deborah Donnell Sten H Vermund Sarah Fidler Richard Hayes Christophe Fraser HPTN 071 PopART Study Team |
| author_facet | Anne Cori Helen Ayles Nulda Beyers Ab Schaap Sian Floyd Kalpana Sabapathy Jeffrey W Eaton Katharina Hauck Peter Smith Sam Griffith Ayana Moore Deborah Donnell Sten H Vermund Sarah Fidler Richard Hayes Christophe Fraser HPTN 071 PopART Study Team |
| author_sort | Anne Cori |
| collection | DOAJ |
| description | <h4>Background</h4>The HPTN 052 trial confirmed that antiretroviral therapy (ART) can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence.<h4>Methods and findings</h4>The HPTN 071 (PopART) trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence.<h4>Conclusions</h4>The HPTN 071 (PopART) trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the impact of treatment as prevention. |
| format | Article |
| id | doaj-art-d61e3aed0aa44de1a85b48d3441f1942 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-d61e3aed0aa44de1a85b48d3441f19422025-08-20T02:34:07ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0191e8451110.1371/journal.pone.0084511HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.Anne CoriHelen AylesNulda BeyersAb SchaapSian FloydKalpana SabapathyJeffrey W EatonKatharina HauckPeter SmithSam GriffithAyana MooreDeborah DonnellSten H VermundSarah FidlerRichard HayesChristophe FraserHPTN 071 PopART Study Team<h4>Background</h4>The HPTN 052 trial confirmed that antiretroviral therapy (ART) can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence.<h4>Methods and findings</h4>The HPTN 071 (PopART) trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence.<h4>Conclusions</h4>The HPTN 071 (PopART) trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the impact of treatment as prevention.https://doi.org/10.1371/journal.pone.0084511 |
| spellingShingle | Anne Cori Helen Ayles Nulda Beyers Ab Schaap Sian Floyd Kalpana Sabapathy Jeffrey W Eaton Katharina Hauck Peter Smith Sam Griffith Ayana Moore Deborah Donnell Sten H Vermund Sarah Fidler Richard Hayes Christophe Fraser HPTN 071 PopART Study Team HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. PLoS ONE |
| title | HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. |
| title_full | HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. |
| title_fullStr | HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. |
| title_full_unstemmed | HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. |
| title_short | HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. |
| title_sort | hptn 071 popart a cluster randomized trial of the population impact of an hiv combination prevention intervention including universal testing and treatment mathematical model |
| url | https://doi.org/10.1371/journal.pone.0084511 |
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