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HIV INCIDENCE ASSAYS WITH IMPROVED SPECIFICITY (R01): PA-12-012

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Components of Participating Organizations

National Institute of Allergy and Infectious Diseases

Application Receipt/Submission Date(s): Multiple dates, see announcement.

The purpose of this FOA is to stimulate the development of cost-effective assays and algorithms with improved specificity and reliability for determining HIV incidence. Ideally, the assay would be accurate for diverse HIV-1 subtypes and could be performed in resource limited settings.

Reliable identification of recently infected persons (within the last 12 months) is essential to derive accurate seroincidence estimates. This information is critical for the design and implementation of HIV prevention trials. For all HIV prevention trials, whether a vaccine, microbicide, oral pre-exposure prophylaxis agent, or another intervention(s) is used, an accurate assessment of HIV incidence in the proposed study population is necessary in order to calculate the required sample size and study duration and thus to determine the feasibility of the trial. For population level prevention trials, an HIV incidence measure is essential for determining the outcome. Additionally, improved methods for detecting recent infections and for distinguishing recent infections from chronic infections are needed (Report of The UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance) for HIV therapeutic trials aimed at determining the effect of early intervention.

Current means of estimating HIV incidence are inadequate The indirect approach, based on the measurement of prevalence in repeated cross sectional surveys, is logistically challenging, takes years to conduct and is difficult to standardize over time. Conversely, direct measurement of incidence through the prospective follow-up of a cohort of HIV-negative persons is very costly and the findings are difficult to generalize beyond the population selected.

Measurement of HIV incidence using current serological methods has also been unsatisfactory. Efforts to use the BED Assay in combination with other measures to improve overall specificity are a significant improvement, but they are complex and cost-prohibitive …

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