Abstract
BackgroundEffective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis.Methods/DesignA rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance.In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes.DiscussionTrial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT.Trial registrationClinicalTrials.gov NCT01900977.
Highlights
Effective interventions to reduce Human immunodeficiency virus (HIV) incidence in sub-Saharan Africa are urgently needed
Evaluation of impact While the interventions will be delivered to the total population of each intervention community, the primary outcome of HIV incidence and a range of secondary outcomes and process measures will be obtained through a Population Cohort
Full ethical review of the trial protocol has been carried out by the ethics committees of the University of Zambia, Stellenbosch University, London School of Hygiene and Tropical Medicine and the United States (US) Centers for Disease Control and Prevention. Both South Africa and Zambia have seen a recent decrease in the incidence of new HIV infections
Summary
Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. The global health burden associated with HIV infection continues to grow, with an estimated 34 million people living with HIV, including 23.5 million adults and children in sub-Saharan Africa [1]. While considerable progress has been made in expanding the coverage of antiretroviral treatment (ART), a large proportion of HIV-infected individuals who need treatment are not yet receiving it. In sub-Saharan Africa, an estimated 2.3 million individuals have commenced ART during the past two years, but during this same period there have been approximately 3.6 million new infections [1]. Unless the number of new infections can be steeply reduced, the number of individuals needing treatment will continue to increase and it will be increasingly difficult and costly to provide ART for all those who need it. Effective HIV prevention remains a pressing priority in the era of ART roll-out
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
