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Evaluation of New HIV Testing Technologies in Clinical Settings with High HIV Incidence

Solicitation Number: 2014-N-16466
Agency: Department of Health and Human Services
Office: Centers for Disease Control and Prevention
Location: Procurement and Grants Office (Atlanta)
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2014-N-16466
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Presolicitation
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Added: May 19, 2014 3:05 pm
The Centers for Disease Control and Prevention (CDC) intends to issue a Request for Proposal (RFP) to support the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP). This will be a new requirement. It is anticipated that the resultant contract will be a cost-plus-fixed-fee type with a period of performance of 72 months (Base Period of 24 months, with two (2) Option Periods for 24 months each). The applicable NAICS code is 541712 with a size standard of 500 employees. The RFP will be posted on FedBizOpps and is expected to be released on or about June 10, 2014. Interested parties are responsible for checking the website regularly for release of the RFP and for other procurement-related documents. TELEPHONE CALLS WILL NOT BE ACCEPTED. The information provided in this pre-solicitation is for information purposes only. If there are any differences in the information provided here and the actual solicitation when released, the information provided in the actual solicitation shall govern.

The CDC/NCHHSTP has a potential requirement to better understand the performance of available HIV tests using fresh whole blood and oral fluid specimens. CDC is particularly interested in sensitivity early in infection, when the antibody response is developing.
 

An estimated 50,000 new HIV infections occur each year in the United States. Men who have sex with men (MSM) are estimated to have the highest incidence of new HIV infections. The first few weeks after HIV infection, referred to as the acute stage in this document, can be defined as the stage when HIV infection can be detected by testing for HIV virus directly, but there is no detectable HIV-specific antibody response. Although clinical sensitivity of tests for HIV antibodies appears to be improving, detection of HIV infection during the acute stage, by definition, requires the ability to detect virus directly rather than relying on detection of antibody. Molecular tests for HIV have traditionally been complicated and expensive to perform, and although a variety of strategies to utilize these tests in clinical settings have been proposed, they are still not widely used. Several new HIV tests have recently been approved by the US Food and Drug Administration (FDA) for use on unprocessed specimens (e.g. fingerstick whole blood and/or oral fluid) at the point-of-care (POC), or their approval is imminent. So that CDC can monitor and update HIV testing guidance that reflects newly available testing technology and characterizes the relative performance of available tests, an evaluation must be conducted to understand the differences in sensitivity of the newest HIV serologic tests using unprocessed specimens collected from infected individuals while they are in the acute stage of disease. In addition, there is a need to evaluate the diagnostic performance of nucleic acid (molecular) tests to allow CDC to determine the applicability of this technology for use in a variety of clinical and point-of-care settings. In order to maximize the yield of persons identified shortly after they have been infected while limiting overall project costs, the study will be conducted in three parts.


The objectives of each part of the proposed project are:


1) To identify persons at high-risk for early infection. In Part 1, up to 50,000 persons presenting for an HIV test at study sites will be categorized as high or lower risk, based on information extracted from their medical records, or collected directly from participants through a short questionnaire. This behavioral screener which will be used on 50,000 participants seeking HIV testing will be used to identify no more than 10,000 highest risk clinic clients for selection for Part 2.
2) The objective of Part 2 is to evaluate the tests under study using fresh specimens collected from no more than 10,000 Part 2 participants, including a minimum of 600 HIV-infected participants and 50 participants with early infection. Part 2 of the study will involve collecting specimens for testing with the HIV testing technologies being evaluated.
3) The objective of Part 3 is to evaluate the seroconversion sensitivity of the new HIV tests through serial follow-up. Participants with discordant test results will undergo frequent follow-up testing to document either seroconversion on all tests being evaluated, two consecutive visits with negative test results on all tests (indicating reactive Part 2 tests were false-positive), or the completion of 70 days of follow-up. It is expected that at least 50 participants with early infection will complete Part 3 follow-up.


It is anticipated that more than one contract may be awarded from the resultant solicitation.


The offeror shall furnish all the necessary personnel, facilities, supplies, equipment, as appropriate, to provide CDC with the required scientific, technical, and operational services, within the general work parameters set forth in the statement of work.


 

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2920 Brandywine Road, Room 3000
Atlanta, Georgia 30341-4146
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United States
:
Kim H. Morris,
Contract Specialist
Phone: 770-488-2621
Fax: 770-488-2044
:
Teri M Routh-Murphy,
Contracting Officer
Phone: 770-488-2713
Fax: 770-488-2778