SPECIAL NOTICE
A -- Evaluation of New HIV Testing Technologies in Healthcare Settings Serving Populations at High Risk for HIV Infection
- Notice Date
- 12/13/2013
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2014-N-15783
- Point of Contact
- Sharon R Cunningham, Phone: 770-488-2871, Teri M Routh-Murphy, Phone: 770-488-2713
- E-Mail Address
-
cux0@cdc.gov, tnr3@cdc.gov
(cux0@cdc.gov, tnr3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes and to enhance study design. The National Center for HIV/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP), is considering the development of a new research project to evaluate new technologies for Human Immunodeficiency Virus (HIV) screening and diagnosis in the United States, and is seeking information relevant to the implementation of this project from healthcare settings serving a patient population with documented high prevalence of acute HIV infection. Background An estimated 50,000 new HIV infections are diagnosed each year in the United States. Men who have sex with men (MSM), particularly young minority 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 clinically as the stage when HIV infection can be detected by testing for HIV virus directly, but without a detectable HIV-specific antibody response. Identification of HIV infection in this acute stage serves a public health need since those with acute infection have large amounts of circulating HIV virus and thus have an increased risk of transmitting infection. Additionally, recent studies suggest that initiation of antiretroviral treatment before the infection affects the immune system confers both clinical and public health benefits. 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. However, 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), or their approval is imminent. Understanding the relative sensitivity of available HIV tests during the earliest stages of infection, including the acute stage and immediately after development of an antibody response, while also maximizing the number of persons with previously undiagnosed infection who are identified and linked to HIV medical care, will require an examination of new HIV testing technologies in high incidence populations, such as men who have sex with men (MSM). So that DHAP 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 analytic and clinical sensitivity of the newest HIV serologic (antibody) tests. In addition, there is a need to evaluate the diagnostic performance of nucleic acid (molecular) tests, to allow DHAP to determine the applicability of this technology for use in a variety of clinical and point-of-care settings. Information Requested CDC is considering several integrated study designs to facilitate the evaluation of new HIV serologic and molecular assays to screen for acute and prevalent HIV infection, and for use as supplemental tests in the HIV diagnostic testing algorithm that includes a 4th generation immunoassay, an HIV-1/HIV-2 differentiation test and a nucleic acid test (the proposed CDC laboratory algorithm for HIV diagnosis). In order to evaluate the analytic sensitivity as a measure of the tests' ability to identify HIV infection during the acute stage, the tests must be evaluated in settings where the testing population has a high incidence of new HIV infection. We propose to evaluate the new testing technologies in 3-4 clinical sites serving MSM with documented high prevalence of HIV infections detected during the acute stage. However, in order to successfully evaluate these new technologies, including those still under investigation for FDA approval, the evaluation will also require that the clinical sites be able to perform real time evaluations of a variety of tests. To do so will require sites to have access to an onsite laboratory classified as moderate complexity under the Clinical laboratory Improvement Amendment managed by the Centers for Medicare & Medicaid Services. Additionally, sites must have access to a laboratory that conducts an algorithm that includes a 4th generation immunoassay, an HIV-1/HIV-2 differentiation test and a nucleic acid test, and be willing to run this algorithm on the entire study population. Finally, the site must have access to a quantitative viral load test for clinical staging of all study participants identified as HIV-infected, and be able to properly store and ship biologic materials to CDC frozen on dry ice. As part of the clinical follow-up, sites will be asked to draw additional blood specimens from participants, and should also have electronic data systems and data management capacity to collect and manage all HIV test results, demographics, behavioral risk data, information on previous HIV testing, and antiretroviral use both prior to diagnosis (e.g. for Pre or Post exposure prophylaxis) and after diagnosis (e.g. as part of a program for early initiation of HIV therapy). As proposed, testing could be conducted over two years on approximately 25,000 study participants, in order to identify a minimum of 500 persons with prevalent HIV infection (prevalence of at least 2%) and 50 persons with acute infections (prevalence of acute infection of at least 0.2%), for enrollment in clinical follow-up. A subset of HIV antibody negative patients will be recruited for serial follow-up visits so that seroconversion sensitivity can be assessed for all tests. They will receive a quantitative viral load test and be followed until one of the following occurs: they become positive on all HIV tests under evaluation, or they complete 9 visits up to 70 days after the initial visit. Participants enrolled in the follow-up study will receive a quantitative viral load after seroconversion with all HIV tests or at 70 days. NCHHSTP and DHAP requests your input on some or all of the following items regarding the design of an evaluation of new HIV testing technologies: 1. Please comment on the approach described above, including the design and feasibility. What are the most important scientific questions that this study should answer? What, if any, critical elements are missing from the proposed study design? Please describe what elements should be considered if any are missing. 2. The ideal clinical site would be able to: conduct a sufficient volume of HIV screening tests (~4,000 tests/year of previously undiagnosed, high-risk MSM populations), have a high incidence of acute infections (at least 2/1000), have the ability to screen with a large number of screening tests, have a CLIA moderate complexity laboratory, be able to conduct the CDC laboratory algorithm on all study participants, receive laboratory results in a timely manner to facilitate enrollment in longitudinal follow-up for those identified in the acute stage, and have the ability to collect required data. How many individual sites do you think might be needed to meet all these criteria? What aspects of this plan would be difficult or impossible for your site to implement? What changes to current procedures/facilities/clinic flow would need to be in place in order for your site to do this work? How might you meet the study objectives in a way that is compatible with your site's capabilities to conduct a clinical research study? What resources would be required to implement this study? 3. In addition to the clinical information being collected (e.g., all HIV test results, prior testing history, HIV viral load at diagnosis and 70 days of follow-up, documentation of linkage to HIV care after diagnosis), what behavioral risk information should be collected from all participants? What types of information should be collected both from acutely infected individuals enrolled in follow-up as well as a (perhaps matched) subset of those individuals identified with prevalent HIV infection? What types of behavioral risk information do you already collect? Can/How would you modify your current information collection procedures to accommodate the collection of additional behavioral information? What additional resources would be required provide these data to CDC? 4. How feasible, or not feasible, would it be for clinical sites conducting the volume of HIV testing outlined in #2 to screen all consenting participants (who presumably came to the test site seeking one HIV test) with a large number (5-7) of new HIV tests? What alternatives to this approach might facilitate the evaluation of a variety of HIV tests in a high-risk population? For example, would newly diagnosed, HIV-infected individuals be willing to enroll in a study in which all tests under evaluation were performed at multiple sequential time points? Or, would a clinical site be able to conduct a brief behavioral screening questionnaire on all individuals seeking testing in order to test only the highest risk subset with the new, more sensitive, but more complicated molecular tests? How would you recommend that DHAP operationalize the process of running many HIV screening tests on a large number of patients who sought HIV testing in your clinic? 5. Biospecimens, including blood, oral fluid, and dried-blood spots, collected from study participants during both screening and follow-up would be processed locally, and stored either at the clinical site or their partner laboratory, prior to shipment to the CDC repository. Please comment on this approach, including: a) the feasibility of having clinical sites collect, process and store specimens locally i. What additional resources (e.g. a biospecimen freezer for storage, an additional centrifuge for specimen processing) might be required in order for your site to accomplish this goal? b) the likelihood of newly diagnosed, HIV-infected individuals consenting to serial follow-up, specimen collection and storage for future testing c) any recommendations for recruitment and retention of such individuals in this phase of the study 6. Please provide any additional information pertinent to the proposed project that we should consider. How to Submit a Response Interested extramural investigators and other interested parties are invited to respond. Responses to this RFI will be accepted until January 09, 2014, 2:00PM EST. Responses shall not exceed 50 pages, double spaced. Please provide information regarding organizational size classification and capabilities, acting individually or in partnership with others, can satisfy the requirement. For example, identify whether your orrganization is small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or a small disadvantaged businesses. Respondents will not receive individualized feedback on any suggestions. However, the respondents may be invited to an opportunity to present via phone or in-person to CDC. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. All comments must be submitted via e-mail as text or as an attached electronic document. Microsoft Word documents are preferred. Please submit your response to the following address: Sharon Cunningham Contract Specialist 2920 Brandywine Road, MS-E14 Atlanta, GA 30341 E-mail: cux0@cdc.gov Disclaimer and Important Notes This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes and to enhance study design. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2014-N-15783/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN03252069-W 20131215/131213235204-133be32477164853e38621ade77367ae (fbodaily.com)
- Source
-
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