Posted: 7 Mar 2012
HIV Incidence Assays with Improved Specificity (R01)
National Institute of Allergy and Infectious Diseases, NIH
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID is one of the 27 Institutes and Centers of the National Institutes of Health (NIH). NIH, like the Centers for Disease Control and Prevention (CDC), is part of the U. S. Department of Health and Human Services (HHS). NIH is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, please visit NIH (www.nih.gov).
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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 in most settings. The development of a cheaper, faster, more accurate HIV incidence assay would greatly benefit the design and implementation of HIV prevention research and likewise be of value to HIV surveillance programs.
The objective of this research program is to promote the identification of biomarkers that can be used to develop HIV incidence assays with improved specificity. Such biomarkers might be based on the evolution of specific viral parameters or host immune responses in the first year after HIV infection. Methods must then be developed for utilizing the biomarker(s) to identify incident cases in a highly accurate, cost-effective assay.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
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