SOURCES SOUGHT
A -- Rapid HIV Testing MSM Study
- Notice Date
- 5/2/2011
- Notice Type
- Sources Sought
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- 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
- RFP2011-N-13417
- Archive Date
- 5/31/2011
- Point of Contact
- Jerry W. Outley, Phone: 770-488-2831
- E-Mail Address
-
jmo4@cdc.gov
(jmo4@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Title: Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities Notice Type: Sources Sought Synopsis: This is a sources sought notice to determine the availability of potential vendors (including, but not limited to, small business (e.g. 8 (a), veteran-owned small business, service-disabled veteran owned small business, HUBZone small business, small disadvantage business, and women-owned small business) that can conduct research on rapid HIV self-testing among MSM in up to three high prevalence cities for up to 4 years. Background: Innovative testing strategies are needed to reduce levels of undiagnosed HIV infection and increase early access to treatment. The availability of a rapid HIV self-test may facilitate access to testing among individuals who have never been tested due to concerns about privacy and confidentiality and may increase compliance with current CDC HIV testing recommendations for those who require regular testing due to on-going risk behavior. Rapid HIV self-tests may play an important role in efforts to reduce both HIV morbidity and mortality. Rapid HIV self-test kits may reduce HIV incidence by helping HIV-negative persons remain free from infection (primary prevention), as well as increase early diagnoses of those who are infected (secondary prevention). Policies that guide the public-health application and use of rapid HIV self-test kits, require data on whether persons at high risk for infection will use these tests, the effectiveness of the tests for primary and secondary prevention, and the utility of the tests in promoting additional testing and linkage to HIV services of persons with preliminary positive results. Repeat testing may be particularly important for men who have sex with men (MSM) at high risk of transmitting HIV since infections in the earliest stages are associated with high viral loads and potential for transmission. MSM account for nearly half of the more than one million people living with HIV in the U.S. and they account for more than half of all new HIV infections in the U.S. each year. While MSM account for just 4 percent of the U.S. male population aged 13 and older, the rate of new HIV diagnoses among MSM in the U.S. is more than 44 times that of other men. MSM are the only risk group in the U.S. in which new HIV infections are increasing. While new infections have declined among both heterosexuals and injection drug users, the annual number of new HIV infections among MSM has been steadily increasing since the early 1990s. The exceptionally high prevalence of undiagnosed HIV infection among MSM and plausibly high transmission risks to partners who are attempting to avoid infection through HIV-negative serosorting, suggests that MSM and their partners stand to benefit the most from a rapid HIV self test. This is especially true for black and Hispanic MSM. One report suggests that young black MSM have nearly 7-times greater adjusted odds for being unaware of their HIV infection relative to young white MSM. Despite this racial disparity, young black MSM (relative to young white MSM) are equally likely to perceive themselves at low risk for infection and are nearly equally as likely to disclose being HIV-negative to new sex partners. Of black MSM with HIV who were unaware of their infection, up to 22% of their new partners reported being HIV-negative. However, of Hispanic and white MSM with HIV who were unaware of their infection, only 3% of new partners of Hispanic MSM and 4% of new partners of white MSM disclosed being HIV-negative. As of March 2011, the FDA has approved six rapid HIV tests for use at point-of-care to aid in the diagnosis of HIV. Several of these tests have received Clinical Laboratory Improvement Amendment (CLIA) waiver for use in non-clinical settings by persons without formal laboratory training and they are accurate, safe, and simple to use. Currently, OraSure Inc. has applied to the FDA for an over-the-counter (OTC) labeling of OraQuick Advance. While manufacturers that seek OTC labeling of rapid HIV tests are obligated to conduct studies to meet FDA requirements on device safety and accuracy, manufacturers will not be required to conduct studies that evaluate the public-health benefit of these tests. Thus, without CDC-supported research, data will not exist to guide the development of public-health policy and programs on the dissemination and use of OTC rapid HIV self tests when they become available. In the absence of such guidelines, CDC will not be able to take full advantage of a promising new application of rapid HIV tests for primary and secondary prevention efforts targeting persons at high risk for infection. Given the unrelenting HIV crisis among MSM and the imminent release into the market of rapid HIV self-test kits, it is necessary to evaluate the impact of providing rapid HIV self-test kits on repeat HIV testing, linkage to care, partner testing, serosorting, and HIV sexual risk behaviors among MSM to determine the potential primary and secondary prevention effectiveness of OTC rapid HIV self tests. This information will assist DHAP in developing recommendations and future research and program needs concerning self-testing for MSM to aid in identifying undiagnosed cases of HIV infection and promoting linkage to care of persons with HIV. Purpose and research questions: The purpose of this sources sought document is to assess contractor capabilities for conducting a longitudinal research study that will evaluate the use of rapid HIV self-tests among MSM in high prevalence cities. Specific research questions include the following: 1. Does provision of rapid self-test kits increase the frequency of HIV testing among high-risk MSM to at least three times in 12 months? 2. What proportion of persons with a preliminary positive result go on to request, be referred to, and access follow-up testing and care services (e.g., primary care provider, health department, or local AIDS service provider)? 3. Does the provision of rapid self-test kits to high-risk HIV-negative or unknown serostatus MSM increase the distribution and use of rapid HIV self-test kits to their social and sexual network affiliates? 4. Does the provision of rapid self-test kits to HIV-positive MSM increase the distribution and use of test kits to their social and sexual network affiliates? 5. Does the provision of rapid self-test kits change sexual behaviors among study participants (e.g. number of partners, unprotected anal intercourse, and serosorting practices)? 6. How do program participants perceive the possible uses, benefits and drawbacks of self testing and what are participant's self-testing preferences, in terms of accessing kits, cost, HIV information, and access to supportive services? The Vendor shall demonstrate capability with the following requirements: 1. Demonstrate experience in conducting longitudinal behavioral HIV prevention research with MSM, including minority (African American and Latino) MSM. 2. Demonstrate evidence of capacity to develop research protocols and related materials for proposed study within 9 months of contract award. 3. Demonstrate evidence of ability to obtain local IRB approval for HIV related research projects. 4. Demonstrate evidence of ability to develop recruitment and retention materials and a recruitment/study information website. 5. Demonstrate evidence of ability to work with state or local health departments and AIDS service organization. 6. Demonstrate evidence of ability to meet the FISMA requirements for data security for the web-based platform prior to data collection. 7. Demonstrate evidence of ability to collect, store, back-up and transfer data from persons recruited into a longitudinal study utilizing a web-based data collection platform. 8. Demonstrate evidence of ability to create and transfer interim and final data sets to CDC. 9. Demonstrate ability to develop and implement an electronic system to track and distribute rapid HIV self-test kits to research participants. 10. Demonstrate ability to provide a comprehensive phone-based counseling, referral, and linkage to care service to all persons who report a preliminary positive rapid test result or person who report being HIV positive. 11. Demonstrate ability to conduct focus groups with MSM. 12. Demonstrate experience of ability to provide required written progress reports on schedule. 13. Demonstrate experience with web-based, complex, multi-site, population-based data collection. Capability Statement: Vendors that believe that they have the ability to satisfy all of the above stated objectives are encouraged to submit a capability statement. The capability statements will be evaluated based on the information provided in relation to the research questions and requirements above and the current in-house capacity to perform the work including: (a) staff availability, experience, and training; (b) prior completed projects of a similar nature; and (c) examples of similar prior completed contracts, dollar value of the contracts, references, and other related information. Capability statements must demonstrate the requirements outlined above. Capability statements shall include the following information: company name, address, point of contact, phone/fax/email, and business size and status (e.g. small business, 8(a), veteran-owned small business, service-disabled veteran owned small business, HUBZone small business, small disadvantage business, and women owned small business). The remainder of the capability statement should be tailored to the requirements stated above and must demonstrate that similar research activities have been performed in the past. Submission Instructions: Interested parties having the capabilities necessary to perform the stated requirements may submit a capability statement of up to 10 pages via email to Jerry Outley (Jmo4@cdc.gov). The subject line of the email shall be "Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities Capability Statement". Responses are due no later than Monday, May 16, 2011 by 2:00PM EST. Capability statements will not be accepted after the due date. Disclaimer and Important Notes: 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 research activities required. 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. RESPONSES TO THIS NOTICE WILL NOT BE CONSIDERED ADEQUATE RESPONSES TO A SOLICITATION. Primary Point of Contact: Jerry W. Outley Contracting Officer Procurement and Grants Office (PGO) 2920 Brandywine Road M/S E-15 Atlanta, GA 30341 Email: jmo4@cdc.gov Phone: 770-488-2831 Fax: 770-488-2868
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