RFP_Questions_RFP_2014-N-16466_Final.pdf

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

Solicitation No. 2014-N-16466

RFP Questions

RFP

Section & Page # Question Response

1. If the applicant is proposing to serve as a coordinating center with multiple sites can the page limit be expanded?

If the applicant is proposing to serve as a coordinating center, an appendix may be attached that describes, for each site, the testing volume and yield at each site, and a description of site-specific procedures if they differ from what is described in the overall proposal. This appendix shall be no more than 20 pages in length.

2. C.2.2, Pg 5 Is the 2% HIV prevalence based on the prevalence of the high risk group or the prevalence of the entire population appearing for testing?

The 2% is for the entire population, it should therefore be higher in the highest risk group.

3. C.2.2, Pg 5 Is the required 2% prevalence for eligible sites over 2 years total or per year?

Per year

4. C.2.2, Pg 5 Is the required 0.2 percent for new infections over 2 years total or per year?

Per year

5. C.2.2, Pg 5 Will applications from sites that can plausibly meet the criteria set forth in section C.2.2 (i.e., 2% HIV prevalence among 2000 previously undiagnosed screened, and documented 0.2% of those in acute infection over the prior 24 months) be considered, as well as those that can definitively document such criteria?

It is expected that proposals will contain sufficient data to demonstrate the ability of a clinical site to meet the criteria set forth in section C.2.2.

6. C2.1, Pg 5 The RFP states: “The objective of Part 2 is to evaluate the tests…from Part 2 participants…including a minimum of 600 HIV-infected participants and 50 participants with early infection.”

Is CDC requesting a total of 650 HIV-infected participants in Part 2, or are the 50 acute infections included in the 600 HIV-infected referenced in the RFP?

CDC is requesting 600 HIV-infected participants with reactive results on all screening tests and at least 50 early infections defined as reactive on at least one screening test but not all tests with follow-up during which they become reactive on all tests. Thus a total of 650 HIV-infected participants.

7. M.2.4.a, Pg 87

Does CDC request that a principal investigator and a data manager/analyst be staffed at each clinic if a coordinating center with 6 clinic partner sites is proposed?

CDC does not request that a principal investor and data manager/analyst be staffed at each clinic. However, scientific oversight and data management are critical to the success of the project. Therefore, the offeror should propose a staffing plan that sufficiently meets these objectives.

8. Will the specimens of all participants who are found to be HIV positive over the course of the study (i.e., minimum of 600 to 720) be used for all the different HIV tests that

Specimens from all Part 2 participants will be screened with all tests. It is expected that there will be 10,000 Part 2 participants to yield a minimum of 600 HIV-infected individuals with positive results on all screening tests. Some

Page # Question Response are being evaluated?

of the 7 tests being evaluated are screening tests and some are supplemental tests. All screening tests under evaluation would be used on all part 2 participants including those positive by the standard of care test who consented to participate. The supplemental tests under evaluation would only be used by those reactive on one or more screening tests. Those Part 2 participants testing negative on all screening tests under evaluation need to be tested with either the CDC recommended laboratory algorithm or pooled

NAT.

9. C.3 Part 2, Pg 6

Part 2 participants (those who are HIV positive by standard of care and those at high-risk for HIV infection) are providing whole blood, oral fluid, and DBS for testing.

Please clarify whether the specimens from ALL Part 2 participants will be tested up to 7 times by the tests under evaluation. For example, will those specimens from all Part 2 participants who screen negative for HIV infection (including screening via a NAT) also undergo testing by up to 7 tests being evaluated? Will those specimens from all HIV positive participants who are not in the acute infection stage undergo testing by up to 7 tests being evaluated?

See Question 8 above

10. C.3 Part 2, Pg 6

Page 6 (last paragraph) describes the need for sites to do “real time” testing using the novel tests provided by CDC – and that the contract sites have access to an onsite laboratory.

a.) Must the “onsite” laboratory be co-located in the same building where the sample is drawn from the patient?

b.) Is it required that this “onsite” laboratory be able to run an algorithm that includes a 4th generation immunoassay, an HIV-1/HIV-2 differentiation test and a nucleic acid test; or a pooled nucleic acid test? Or is it acceptable that the site send samples to a local laboratory that has these capabilities?

a) A site needs to be able to run tests and provide results of FDA-approved tests in near real time (e.g. in one hour) to allow for enrollment in Part 3

b) The 4 th generation algorithm or pooled NAT can be performed offsite and results linked back to onsite testing results (with tests under investigation)

Page # Question Response

11. F.3.1 and F.3.2, Pgs 33-35

The deliverable tables request data from 12,000 screened participants, 240 HIV-infected persons, and 16 individuals with acute infection for the base period, and again for both options one and two, for a total of 36,000 screened participants, 720 HIV-infected participants, and 48 individuals with acute infection. Please confirm that these numbers conform to what CDC expects for the full project and not just one site.

The numbers listed in the deliverables table apply to the full project. To clarify, for Option Years 1 and 2 the deliverable numbers are given per year. An estimated 48,000 would be screened and up to 1240 positives and a minimum of 50 participants with early infections with complete follow-up could be identified over the life of the contract if both options were exercised.

12. For a single contractor proposing a consortium of clinical sites to meet the overall project deliverables, is it necessary that each clinical site in the consortium meet the minimum specifications of 2000 screened, previously undiagnosed individuals, 2% prevalence, and 0.2% acute infections?

Yes. Each clinical site needs to meet the minimum specifications of 2% prevalence and 0.2% acute infections such that 40 previously undiagnosed infections and 4 acute infections would be identified each year.

13. Would a proposal from a single contractor that only partially met the overall requirements of 36-50,000 screened, 600- 720 cases of previously undiagnosed HIV infection, and 48-50 individuals in the acute infection stage be considered for award?

Yes, as long as they meet the minimum per year requirements which are 40 HIV-infected persons and 4 acute infections per year.

14. C.2.1, F.3.1 and F.3.2, Pgs 4-5, and 33-35

Given the slight non-agreement in the numbers from the deliverable tables compared to those in the section C.2.1 – i.e., 36,000 vs 50,000 screened, 720 vs 600 HIV-infected, and 48 vs 50 persons in the acute stage, are we correct in concluding that the more important/critical numbers for CDC to observe over the course of the project are the number of infected participants and acute infections? If a site or sites is/are able to observe proportions of HIV-infected and those in the acute stage higher than 2% and 0.2% respectively, are they permitted to screen less than 2000 annually?

Yes, the yield is designed to be a minimum of 2% and 0.2% respectively. Sites that have higher prevalence than this could screen fewer than 2000 participants to meet the objectives of Parts 2 (which are at least 40 [2000 x 2%] HIV-infected persons and 4 [2000 x 0.2%] acute infections per year.

Page # Question Response

15. C.4.a, Tasks

1.12.2 and 1.14, Pgs 10-11

Are sites required to screen a minimum of 2000 annually (or whether the full project is required to screen 12,000 annually) as specified in Task 1.12.2 if they can meet the specifications of Task 1.14 (400 high-risk participants of whom 40 have previously undiagnosed HIV-infection).

See Question 14, screening fewer in the presence of a documented prevalence >2% and yield of acute infections >0.2% is allowable, but no more than 400 Part 2 participants should be required to identify 40 undiagnosed infections.

16. C.4.a, Task 1.17, Pg 11

Task 1.1.7 states that sites should identify a minimum of 2 participants in the acute infection stage (of the 400 high-risk enrollees, 40 of whom are previously undiagnosed cases of HIV-infection). This corresponds to an acute infection proportion of 0.1% (2/2000 screened) rather than the 0.2% specified in the minimum site requirements. Is this discrepancy only for the first year as operations are starting?

Please clarify.

This would correspond to the lower limit of a confidence interval around a true proportion of 2%. Overall for the life of the project the yield would need to be 0.2% or higher in the underlying population to reach the goal of at least 50 acute infections followed through completion of Part 3 follow-up.

17. Are sites that screen only MSM eligible? Or do sites need to access all potential HIV risk groups?

It is expected that sites that screen a predominantly MSM population would be the sites most likely to meet the prevalence and yield of acute infection criteria required for the project. Sites are not required to access all potential HIV risk groups.

18. C.4.a, Task 1.5, Pg 8

Can CDC provide more information regarding the processing and storing of samples that need to be shipped? For example, how soon does a whole blood sample need to be frozen? At what temperature?

The specimens would need to be processed and frozen so that they meet the specifications for NAT as described in FDA approved test package insert. This includes separating plasma from cells within 6 hours of collection through centrifugation and freezing plasma aliquots as soon as possible but no more than 5 days after specimen collection.

19. H.10, Pg 48 Will the contractor be required to submit a Privacy Impact Assessment?

H.10 (c) specifies contractor security deliverables.

Deliverables are due within 30 days of contract award.

20. H.10.c.3, Pg 50

What is the FIPS 199 security categorization level for this system? Is it correct to assume that it will be categorized as moderate?

The FIPS 199 security categorization level will be determined after contract award. However, for development of the offeror’s business proposal, the assumption of a moderate system is sufficient.

21. H.10.c.4 Pg 50

Will the contractor be self-certifying in the certification and accreditation (C&A) effort?

If so, what is the expected level of involvement from the contractor? Are there any ongoing C&A deliverables that should be included in the proposed budget?

The Scope of Work does not specify a requirement to create a new data system, if existing systems are sufficient (with or without modification). If the offeror proposes to develop a new data system, then security requirements as specified under H.10 would apply. The offeror would therefore want to budget for any required deliverables under H.10, and the

Page # Question Response deliverable table for the contract would be modified to reflect these deliverables.

22. Please confirm that this solicitation is limited to sites in the United States. If international sites may apply, is the patient population limited by HIV clade or geographic location?

The RFP does not state a geographic limitation to clinical sites. However, in order to meet the requirements specified in the Scope of Work, an offeror would need to demonstrate the following for any international site:

Access to the exact test kits available in the US (e.g. FDA approved version) and that the kits could be delivered in a timely and economical manner.

Access to comparable populations for which we are trying to collect data in the U.S. (e.g., same incidence, prevalence and risk factors) and some degree of subtype B infections.

Training of staff and equipment is comparable to the U.S. and that Quality Control/Quality Assurance requirements are also comparable to the U.S. sites as all of these aspects could greatly influence the test data.

Ability to ship samples back to CDC following proper export and cold chain requirements.

23. Please confirm that Federal, State or local institutions may apply to be sites?

Federal institutions may not apply to be sites. State and local institutions may apply as long as the offeror complies with federal, state, or local health and safety requirements.

24. L.2.C, Pg 71 Please clarify the awards: six (6) awards or one (1) overall contract.

There will be no more than 6 awards/contracts awarded under this mechanism. Less than 6 awards/contracts may occur if the offeror(s) can complete required deliverables.

25. Please clarify the font size for graphics; can the size be smaller than 12 point?

Yes, as long as it remains legible in printed form.