Project Overview

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Background

The IeDEA RFA was released on February 15, 2005 with an application receipt date of July 26, 2005. The complete RFA can be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-05-014.html.

A meeting (IeDEA meeting) was held on September 28-29, 2004 in Bethesda, MD which brought together international HIV researchers to address the necessity and the potential for international collaborations. The overwhelming consensus of the meeting was that there is a need, the feasibility and the interest in combining data from different settings and cohorts to address those issues in HIV/AIDS which cannot be answered by single cohorts.

Description of the IeDEA initiative

This initiative will establish international regional centers for the collection and harmonization of data and the establishment of an international research consortium to address unique and evolving research questions in HIV/AIDS currently unanswerable by single cohorts. High quality data is being collected by researchers throughout the world. This initiative provides a means to establish and implement methodology to effectively pool the collected data—thus providing a cost effective means of generating large data sets to address the high priority research questions. Combination of data collected under various protocols is frequently very difficult and not as efficient as the collection of pre-determined and standardized data elements. By developing a pro-active mechanism for the collection of key variables, this initiative will enhance the quality cost effectiveness and speed of HIV/AIDS research.

Review of applications

The peer review of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) grant applications was held December 6-7, 2005. The following applicants received fundable scores:

Table 1

The estimated number of individuals covered in each of the regions is included below (Table 2). Data from more than 200,000 HIV-infected persons from 38 different countries are currently included under this initiative. Many regions anticipate expanding their coverage during the latter years of their 5-year funding so the numbers below are minimal estimates. Several regions have access to data from HIV-infected children, the number of children included will likely increase as ARVs are increasingly available to them.

Table 2

One data center has been funded from seven of the IeDEA regions listed in the RFA (Table 1). Each individual data center, in collaboration with multiple independent researchers within their region, has put forth a scientific agenda to address relevant regional HIV research questions. The sources of data to answer these questions include independently-funded investigators and clinical networks, domestic and international cohorts, individual clinicians caring for large numbers of HIV-infected persons, and national or local databases.

The regional data centers form the IeDEA consortium and the principal investigators along with NIH program officers constitute the IeDEA Executive Committee (EC). The EC will identify key information that should be obtained across the participating sites, create standardized definitions for clinical outcomes and events, and develop protocols for data collection, coding and merging. In addition, the EC will identify research questions to be addressed with multi-regional or consortium-wide data and review protocols from non-consortium investigators proposing collaborations with the IeDEA consortium. The Research Triangle Institute will serve as the IeDEA EC Coordinating Center to coordinate consortium activities, including management of data analysis protocols; coordinating communication between regions through meetings, conference calls, and a website; and liaising with non-consortium investigators.

These awards will be issued as cooperative agreements, giving Program and the investigators flexibility in determining their individual research agendas. Their proposed research plans include describing the natural history and complications of HIV infection; the impact of HIV and TB; evaluating strategies to provide ART to children and adults; optimizing HIV treatment adherence; monitoring care and clinical outcomes of ART in adults, children and pregnant women, particularly treatment toxicities, TB, other opportunistic infections, immune reconstitution syndrome, hepatitis B co-infection and viral resistance; examining the genetic variation of the HIV virus; evaluating the effectiveness of ART; describing the effects of long-term treatment regimens and the effects of aging and malignancy. While many of these research topics can and have been addressed by individual cohorts, one strength of the IeDEA initiative is the increase in statistical power gained through combining cohort data. More data and larger sample sizes allow, for example, comparisons of different specific treatment regimens, determination of the risks of rare outcomes, and, by comparing data across IeDEA regions, evaluation of the role of race and genetics on the natural history of HIV infection and response to treatment. Individual cohorts of HIV-infected children are frequently small and combining data across many cohorts increases the ability to make meaningful analyses of HIV infection in the pediatric population. Additionally, by standardizing the collection and definitions of data elements, higher quality data are produced and, hopefully, a standard is created to which future research can be modeled.