RFP_2014-N-16466_07-07-14.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 90

2. CONTRACT NO.

3. SOLICITATION NO.

2014-N-16466

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

07/07/2014

6. REQUISITION/PURCHASE

NO.

HCVJC5X2-2014-68641

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 7 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in 2920 Brandywine Road, Colgate Bldg, Security Desk until 2:00p local time 08/22/2014

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Kim Morris

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2621

C. E-MAIL ADDRESS

ycy1@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 60

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 4 X J LIST OF ATTACHMENTS 64

X D PACKAGING AND MARKING 30 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 31 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 32 X K OTHER STATEMENTS OF OFFERORS 65

X G CONTRACT ADMINISTRATION DATA 38 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 66

X H SPECIAL CONTRACT REQUIREMENTS 45 X M EVALUATION FACTORS FOR AWARD 85

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 2536 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention

Acquisition and Assistance Branch 1

2920 Brandywine Road, MS E-15

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM

SUPPLIES / SERVICES

QTY / UNIT

UNIT PRICE

EXTENDED PRICE

BASE YEAR

Evaluation of New HIV Testing Technologies in Clinical Settings

1 Job with High HIV Incidence September 2014 through September 2016

OPTION YEAR 1

September 2016 through September 2018

OPTION YEAR 2

September 2018 through September 2020

B.1. Brief Description of Supplies or Services

The Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), requires the services of a Contractor to evaluate the performance of available HIV tests and to use this information to update future CDC guidance on new HIV testing technologies.

B.2. Contract Type

This is a cost plus fixed fee (CPFF) type contract with option periods. This contract shall contain a Base Period, an Option Period One and an Option Period Two. The exercise of an option shall be in accordance with FAR 52.217-9, Option to Extend the Term of the Contract (March 2000).

B.3. Estimated Cost – Option

a. The estimated cost of the BASE PERIOD of this contract is $ .

b. The fixed fee for the BASE PERIOD of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Section I of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the BASE PERIOD is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION in Section H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost Fixed Fee Estimated Cost Plus Fixed Fee

Base Period - (24 months)

Option Period 1 - (24 months)

Option Period 2 – (24 months)

Total [Base Period and Options]

B.4. Performance-Based Preference

Pursuant to FAR 37.102(a) (2), the Contracting Officer will use performance-based acquisition methods to the maximum extent practicable.

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

SECTION C - DESCRIPTION/SPECIFICATION/PERFORMANCE WORK STATEMENT

C.1. Introduction/Background

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 number of new HIV infections

. The first few weeks after HIV infection, referred to as the acute stage, 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

. 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 confers both clinical and public health benefits . Although early 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. Understanding the relative sensitivity of available HIV tests during the earliest stages of infection, including the acute stage and during 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).

CDC provides guidelines for HIV testing and diagnosis for the United States, as well as programmatic technical guidance for its grantees. So that CDC can monitor and update these guidance documents to reflect newly available testing technology and characterize 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.

C.2. Scope of Work

C.2.1. Project Objective and Scope

The goal of this project is to evaluate the performance of the newest 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. 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. A flow chart describing the eligibility criteria and populations included in each part is provided as Attachement J-10 (See Section J, List of Attachments).

The objective of Part 1 is 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. The approximately 40,000 persons categorized as low risk will be offered the current standard of care for HIV testing at the clinical site. The Contractor will report data collected with the Part 1screening questionnaire and standard-of-care HIV test results from all clients who seek HIV testing in the clinic in order to evaluate the effectiveness of the medical record/questionnaire data for limiting the Part 2 population to only the highest risk clients, and to provide HIV test results to document HIV prevalence in the lower risk population.

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. Those categorized as high-risk based on Part 1 will be immediately enrolled in Part 2. If individuals identified as low-risk in Part 1, who are offered standard of care testing, receive a test result indicating HIV infection, they will also be offered the opportunity to enroll in Part 2 of the study. Part 2 participants will have blood and oral fluid specimens collected for the evaluation of the new HIV tests, and all test results as well as results from an additional short behavioral questionnaire will be reported to CDC. Part 2 participants with discordant test results (i.e., those with reactive results on one screening test and non-reactive results on another screening test), will be eligible for Part 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.

C.2.2. Minimum Patient Sample Size and the Clinic Site’s Minimum Qualification

The Contractor must ensure that each clinical site currently screens at least 2,000 previously undiagnosed patients each year for HIV, and can document an HIV-prevalence of at least 2% in this population. Additionally, the Contractor must be able to document at least 4/2000 (or 0.2% of those screened) patients diagnosed in the acute stage (as defined in Section C.2.1 above) per year of HIV screening, documented with data from the 24 months prior to responding to this request for proposals. If the Contractor collects information on clients risk, and would meet these minimums if a high-risk subset was considered, this should be stated in their proposal. Finally, the Contractor must be able to demonstrate prior experience with research studies involving clinical follow-up in their clinic population, and electronic information management systems which either already collect, or which can be modified to collect, the clinical and risk information required to fulfill the objectives of the research contract.

C.3. General Requirements

The Contractor shall implement the following study components:

Assessment of eligibility and informed consent Persons seeking HIV testing at the study clinical sites will be eligible for enrollment in the initial phase of the study.

However, for all study phases, participants must be: A) old enough to consent for HIV testing, and B) not known to have been previously diagnosed with HIV infection (e.g. persons seeking an HIV test to confirm their diagnosis and initiate care are not eligible for the evaluation). If, as part of their routine practice, the contractor collects information required to identify high-risk clients for Part 2 of the study, they may use this information to screen the population for Part 2. If the contractor does not currently collect this information they will identify potential participants meeting criteria A and B above, describe all three parts of the study, and obtain consent for collection of the information to be collected in Part 1. In this case consenting participants will be enrolled in Part 1.

Evaluation of screening questionnaire If the contractor does not routinely collect information necessary to limit the population to a highest risk subset, up to one (1) year of data will be collected by the Contractor as an evaluation of the types of questions described below as the Part 1 questionnaire. This evaluation will be used to validate that the questions included will both limit the population to a sufficiently small subset of the overall patient population and accurately identify those at highest risk for recently acquired HIV infection. During this time period CDC will conduct an assessment of all data collected, including risk characteristics and previous testing history of both those enrolled in what is described below as Part 2 and those who were screened but not determined to be eligible. CDC will use the evaluation to refine and finalize the screening questions used for the remainder of the study. If the contractor routinely collects behavioral data and can document that a specific set of screening questions will identify the highest risk subset with yield of previously undiagnosed patients equivalent to an HIV-prevalence of at least 8% and at least 4/500 patients diagnosed in the acute stage (as defined in Section C.2.1 above) then the contractor may use this existing data to justify the screening criteria to be used in Part 1.

Part 1 - Risk assessment to identify the highest risk subset of the patient population

Part 1 will consist of the collection of descriptive and risk characteristics of the study population, and ascertainment of client risk level as criterion for eligibility for Part 2. Depending on the information collected routinely at clinical sites, Part 1 participant information will either be extracted from the clinical record, or collected directly from participants through a short questionnaire. Basic demographic information, HIV testing history, history of HIV prophylaxis and HIV risk in the prior three (3) months will be collected. Those categorized as high-risk based on this information will be enrolled in Part 2 of the study, which includes testing with novel HIV testing technologies. Those not categorized as high-risk will be offered the HIV test routinely offered to clients seeking HIV testing at the clinical site, hereafter referred to as the “standard-of-care testing”, the costs of which shall not be covered under this research contract. If individuals receiving standard of care testing receive a test result indicating HIV infection they will also be offered the opportunity to enroll in Part 2 of the study.

For all Part 1 participants, the Contractor shall report de-identified survey data collected during screening, and shall also report the results of HIV testing conducted using the Contractor’s standard of care HIV test(s). If the Contractor is using an existing set of behavioral questions to screen for Part 2 participants, these de-identified data and test results should be reported for all clients seeking HIV testing at the clinic that would be eligible for Part 2.

These data are necessary to describe the underlying population from which Part 2 participants arise, and to document the utility of the screening questionnaire for identifying the highest risk subset. The Contractor shall develop and maintain a system to link Part 1 participant information to those data collected in Parts 2 and 3 as described below.

Part 2 – Evaluation of new HIV testing technologies among the highest risk subset of the clinic’s population and those at lower risk with previously undiagnosed HIV infection.

Part 2 participants will consist of two groups of clinic patients: those deemed to be at highest risk for recent HIV infection based on the Part 1 screening criteria, and those testing HIV-positive on the standard of care test conducted at the clinic. The latter group is being included to increase sample size for evaluation of the sensitivity of the tests under investigation. Those consenting to participate in Part 2 will have anticoagulated (EDTA) whole blood, oral fluid and dried-blood spot specimens collected for the evaluation of the new HIV screening and diagnostic tests, and will also consent to the collection and storage of specimens for future testing. The Contractor shall use fresh anticoagulated (EDTA) whole blood and oral fluid specimens to perform up to seven (7) different HIV tests. For the option periods, CDC may change the tests under evaluation depending upon the performance of the tests during the Base Period and the availability of new tests over time; however, no more than seven (7) tests are expected to be included in any evaluation period.

In order to successfully evaluate these new technologies, including those still under investigation for FDA approval, the evaluation will require that the contractor’s clinical site be able to perform a variety of tests on unprocessed specimens, in real time. To do so will require contract sites to have access to an onsite laboratory with laboratory staff that will need to demonstrate proficiency with each test and conduct regular quality control testing during the study. Additionally, clinics must have access to a laboratory that conducts either an algorithm that includes a th generation immunoassay, an HIV-1/HIV-2 differentiation test and a nucleic acid test, or pooled nucleic acid testing of all those who screen HIV-negative onsite, and be able to run these tests on the entire Part 2 study population with negative test results on all tests under evaluation as the reference standard for the evaluation of the new test technologies. Finally, each clinic must be able to perform a quantitative HIV-1 viral load test for all study participants identified with a reactive result on at least one (1) test under evaluation, indicating possible HIV-infection, and be able to properly store and ship biologic materials collected for future testing to CDC frozen on dry ice.

Data collected from Part 2 participants will include all test results (for the new tests under evaluation, testing with the reference standard, and HIV-1 viral load) as well as a short behavioral questionnaire that will provide more detailed and standardized risk behavior data than the Part 1 screener. These data will be de-identified before being reported to CDC, but should include a link between Part 1 information and the data generated in Part 2.

Specimens collected from those with at least one (1) reactive HIV test and the first 1000 persons with non-reactive results on all tests will be stored for shipment to CDC.

Participants with at least one (1) reactive HIV screening test result and at least one (1) non-reactive HIV screening test result, in other words with discordance between the HIV screening tests, will be eligible for Part 3.

Part 3 – Serial follow-up of those with discordant Part 2 test results

Participants with discordant Part 2 screening test results will be eligible for Part 3, involving serial follow-up to resolve these discrepancies and to assess seroconversion sensitivity for all tests. It is expected that Part 3 participants will comprise a mix of those having falsely reactive screening test results and those in the process of seroconverting after the acute stage of infection. The contractor shall ensure that Part 3 participants complete the behavioral questionnaire and have a quantitative viral load test from a specimen collected during their initial visit prior to completing Part 2. The Contractor shall consent and enroll participating patients in serial follow-up until one of the following occurs: they become positive on all HIV tests under evaluation, they have two (2) consecutive visits on which all tests are HIV negative, or they complete nine (9) visits up to 70 days after the initial visit. The complete follow-up schedule will involve return visits at 3, 7, 10, 14, 21, 28, 42, 56, and 70 days after the initial visit. The Contractor must demonstrate prior experience conducting clinical follow-up with patients at regular intervals and a plan for re-contacting participants who fail to return for a scheduled follow-up visit. At each follow-up visit the Contractor shall collect EDTA whole blood and oral fluid specimens for same day testing with the HIV tests under evaluation. Additional specimens, including a minimum of 4ml of EDTA plasma, two (2) oral fluid collection tubes and DBS, will be collected from all Part 3 participants at each visit for storage and use in future HIV test evaluations. The Contractor shall conduct a second quantitative viral load test for each Part 3 participant after seroconversion with all HIV tests or at 70 days. Finally, Contractor shall administer the same questionnaire administered to Part 2 participants again at the last follow-up visit.

C.4. Technical Requirements

The Contractor shall, as an independent organization and not as part of the Government, furnish all necessary services, facilities, equipment, qualified personnel, and material (except for those to be furnished by the Centers for Disease Control and Prevention (CDC) as specified elsewhere in this solicitation) to perform the work required by the Statement of Work as set forth below:

A. Base Period: Plan for integrating protocol at clinical site, IRB approval and 12 months of data collection

(Date of Award through 24 months thereafter).

Task 1.1: Kick off net meeting. Within 30 days of the award, all Contract staff shall meet with CDC project staff via net meeting to discuss the clinic-specific issues in integrating the study into the clinic setting, to clarify the scope of work and delivery schedule, to further delineate roles and responsibilities, and to establish communication protocols. Duration: one-day meeting. The meeting shall be attended by the CDC staff, and Contractor key personnel. The Contractor(s) shall provide draft minutes of the meeting within one (1) week. CDC shall respond with comments, and final minutes will be submitted to the CDC COR within two (2) weeks of the kick-off meeting.

Task 1.2: Conference Calls During Protocol Development and Approval. Contractors shall coordinate and participate in weekly telephone conference calls with CDC staff to communicate progress in the plans/project for integrating the protocol into its specific clinic setting. Contractors will provide draft minutes and a list of action steps of each call within two (2) business days of the call. CDC will respond with comments, and final minutes from each call will be submitted to the CDC COR at least one (1) day prior to the next call (i.e., within one (1) week of completion of the call).

Task 1.3: Feedback and Written Revisions to Draft Study Protocol. CDC staff will provide a draft protocol to Contractors prior to the Kick off net meeting. Within 20 business days (4 weeks) of the meeting, Contractors shall independently prepare written modifications to accommodate clinic-specific issues in integrating all aspects of the protocol into their clinic setting and send to CDC in a Microsoft Word (either 2003 or 2007 compatible) document identified by date and version number. CDC staff will review the Contractor’s written modifications and request additional or clarifying information as needed. The contractor shall address all of the CDC’s queries within 20 days and submit written responses in a Word document including date and the new version number. Up to three (3) iterations of modifications and response may occur, prior to CDC’s acceptance of the draft revisions. Following CDC’s acceptance of the draft revision, the Contractor shall submit the final draft of their site specific protocol that contains any modifications directed by the CDC.

Task 1.4: Feedback and Written Revisions to the Part 1 and Part 2/Part 3 Questionnaires. CDC will provide a draft of both the Part 1 screening questions and the Part 2/Part 3 questionnaire to the Contractor prior to the initial net meeting. CDC intends to provide the questionnaires and consent forms in both English and Spanish. If another translation of the consent form is perceived to be necessary for protocol implementation at a given clinical site, the Contractor should state this in the application and describe plans for conducting translation and certification of the consent forms and questionnaires as necessary to complete this Task (1.4). The Contractor shall document which elements, if any, of the questionnaire are already collected at the Contractors clinical site and propose alternatives to CDC’s questions where necessary to be consistent with data already being collected. The Contractor shall independently prepare written comments and modifications regarding the questions, response alternatives, and formats in the questionnaire and send to CDC in a Microsoft Word (either 2003 or 2007 compatible) document identified by date and version number within 20 days of receiving the draft from CDC. Up to three (3) iterations of modifications and response may occur, prior to CDC’s acceptance of the draft revisions.

Following CDC’s acceptance of the draft revision, the Contractor shall submit the final draft of the questionnaire to the CDC COR.

Task 1.5: Patient specimen processing, storage and shipment procedures. The Contractor shall provide standard operating procedures for collection, labeling, processing, storage and shipment of all specimens to be collected in Part 2. This will include plans for: a) collection and labeling of fresh unprocessed specimens (EDTA whole blood and oral fluid) used for the point-of-care screening tests at the clinical site; b) labeling, processing and shipping, when required, of specimens for testing with the laboratory test(s), described in Section C.4 above as the reference standard for the evaluation of the new test technology; c) labeling, processing and shipping, when required, of specimens for the quantitative HIV-1 viral load test to be conducted on study participants identified as HIV-infected. Finally, this protocol will include descriptions of how specimens will be aliquoted and properly stored until shipment to CDC. Shipping procedures shall be in accordance with US DOT HazMat Regulations (49 CFR Parts 100-185) and the IATA Dangerous Good Regulations (DGR) (Appendix B) provided as Attachment J-11 (See Section J, List of Attachments).

Task 1.6: Description of Database for collecting demographic and questionnaire data. The Contractor shall use an electronic database to store information on each participant, including all data elements agreed to under Task 1.4.

The Contractor shall provide a written description of the database, including a description of how data collected from participants in Parts 1, 2, 3 will be added to existing electronic patient records, and how data will be extracted without identifiers except the unique study identifier that links participant data between Parts 1, 2, and

3. The Contractor shall include a field indicating participant consent for participation in all parts (1,2,3) of the study. Examples of the additional types of data to be provided to CDC include patient demographics (race, gender, age), prior testing history (ever tested, last test time (categorized as > 3 years ago, 1-3 years ago, or months ago if tested in the past 12 months), and for those tested in the past 12 months, number of tests in that time period), prior HIV diagnosis, use of HIV pre-exposure prophylaxis in the past three (3) months, and risk-behavior data collected as part of the Part 1 screening questionnaire. Individual-level data should be provided for all participants within the pool of clients from which Part 2 participants are selected, including a link to records for additional data to be collected from participants in Parts 2 and 3. The link between these data elements for each Part of the study shall be accomplished through a unique study identification number added to the data before shipment to CDC, and not a clinic medical record identification number which might be identifying. The Contractor shall utilize the CDC Secure Access Management System (SAMS) to upload encrypted data. To ensure the database extraction process is implemented as intended, one transmission of dummy data to CDC via SAMS will be completed prior to data collection.

Task 1.7: Descriptions of database for collecting HIV test results. The Contractor shall collect individual-level HIV test results for all tests conducted on all patients in Part 1 as well as Part 2. The Contractor shall provide a written description of how HIV test results data will be stored and extracted, including procedures for maintaining the link to other databases as defined in Tasks 1.6 and 1.8 using a unique study identifier. Test results will include those for the POC testing with new tests under evaluation, testing with the reference standard, and HIV-1 viral load when required, as well as results of testing performed at each follow-up time point for Part 3 participants. Each patient shall be identified by a unique study identification number, not clinic medical record identification number.

The Contractor may choose to develop their own data collection system consistent with CDC requirements for data elements as agreed to under Task 1.4. However, if the Contractor chooses this mechanism to collect and store the data, the contractor should plan for completion of the Certification and Accreditation process (further described under SPECIAL CONSIDERATIONS) below for all data systems which will house data collected as a result of this contract. If the Contractor chooses this option, the unique patient identifier created for the study must be used to link the data from the external data collection to any data collected directly in the medical records database (e.g.

HIV screening test results for low risk Part 1 participants subsequently enrolled in Part 2 after a reactive HIV test).

Alternatively, the Contractor may modify their existing electronic medical records database(s) to contain variables for results of all HIV tests performed on all patients. Regardless of the mechanism the contractor chooses to store the data, Contractors will utilize the CDC Secure Access Management System (SAMS) to upload data. To ensure the database extraction process is implemented as intended, one transmission of dummy data to CDC via SAMS will be completed prior to data collection.

Task 1.8: Description of database for collecting specimen repository data. The Contractor shall work with CDC to develop a database within which all samples collected for storage and future testing are documented. The Contractor shall provide a written description of how the database includes the unique patient identifier linking each specimen to other study data, and fields describing the volume and location (in box, row and column format) for each specimen aliquot. Format for this database shall be agreed upon prior to IRB approval and collection of the first specimens for storage. To ensure the database extraction process is implemented as intended, one transmission of dummy data to CDC vis SAMS will be completed prior to data collection.

Task 1.9: Local IRB Submission and Approval (within four (4) months of receipt of CDC approved local study protocol). The contractor shall receive the CDC-approved protocol developed in Task 1.3-1.5 (SOP, questionnaire, and laboratory procedures) and including information on data collection, storage and security as described in Tasks

1.6 - 1.8, and modify its format according to the required format for submission to the local-site IRB. Following local-site IRB approval, the Contractor shall deliver to CDC the IRB approval letter and a copy of the IRB-approved consent form with approval and date indicated. At this point, if necessary, the CDC will finalize and submit the required information for review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

Task 1.10: Conference Calls During Study Implementation. Contractors shall coordinate and participate in twice monthly telephone conference calls with CDC to communicate progress. It is expected that enrollment in Part 1 will begin as soon as feasible after local IRB approval including an estimated six (6) months for OMB review for the Paperwork Reduction Act, if required (herein referred to as “OMB Approval”). Once recruitment for the study commences there may be more frequent conference calls during the initial start-up of study recruitment. The

Contractor shall provide draft minutes and a list of action steps of each call within two (2) business days of the call.

CDC will respond with comments, and final minutes from each call will be submitted to the CDC COR within one (1) week of completion of the call.

Task 1.10.1: Monthly Progress Report. The Contractor shall provide CDC a monthly progress report two (2) business days before the last conference call of the month. The progress report shall include data on cumulative number of patients accepting enrollment into the study, number of persons tested and identified as HIV-positive and number of completed supplemental assays. The format for the progress report is attached in Appendix C provided as Attachment J-12, (See Section J, List of Attachments).

Task 1.11: CDC site visit. Within 60 days of completion of OMB approval or Task 1.9 (whichever is sooner), the Contractor shall meet with CDC project staff to discuss their final site preparation for integrating the study into the clinic setting and delineation of roles and responsibilities. These meetings shall take place at each clinical site. The Contractor shall provide a draft agenda for CDC’s review approximately one (1) month prior to the site visit.

Duration: two-day meeting. The meeting shall be attended by the CDC staff, and Contractor key personnel. The contractor shall provide to the CDC COR draft minutes from each CDC implementation site visit within one (1) week of completion of the site visit for CDC’s review. The Contractor shall be responsible for developing the final meeting minutes based on CDC feedback no later than one (1) week after receiving feedback from CDC’s review.

Task 1.12: Part 1 screening

Task 1.12.1: Evaluation of questionnaires and study procedures for Parts 1-3. Over a three (3) month period after the date of IRB or OMB approval, whichever is later, for each clinical site the Contractor shall identify a minimum of 500 participants for Part 1, and provide basic demographic, HIV testing, prophylaxis and risk history data on all participants. For those not considered high-risk based on the screening questionnaire, the Contractor shall also provide the HIV test results conducted under the clinic’s current standard of care HIV testing procedures. The cost of standard of care testing for participants not considered high-risk is not part of this contract. If data collected from the first 3,000 Part 1 participants (totaled across all sites) which is expected to occur during the first three (3) months of the evaluation, suggest that screening criteria for identification of high-risk participants is not yielding the expected number of participants for Parts 2 and 3 based on the criteria set forth in section C.2, the CDC may modify the Part 1 screening questions and the Contractor shall conduct up to three (3) additional months of data collection to evaluate the revised screening questionnaire.

Task 1.12.2: Part 1 screening. Over a 12 month period after the completion of the evaluation described in Task 1.12.1 above, the Contractor shall utilize the screening questionnaire on a minimum of 2,000 participants in Part 1 at each clinical site for a minimum total of 12,000 participants across all sites, and provide basic demographic, HIV testing, prophylaxis and risk history data on all participants. For those not considered high-risk based on the screening questionnaire, the Contractor shall also provide the HIV test results conducted under current standard of care HIV testing for the clinical site. The cost of standard of care testing for participants not considered high-risk is not part of this contract.

Task 1.13: Transmit Part 1 Data to CDC. In the first six (6) months after enrollment begins, the Contractor shall transmit data to CDC on a monthly basis; after this time the Contractor shall transmit the data on a quarterly basis.

Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data. All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point. The Contractor shall ensure all consent information is 100% complete and all data on the Part 1 screener for all participants eligible for Part 2 is 100% complete prior to submission to CDC.

Task 1.14: Administer Part 2 specimen collection, HIV testing and questionnaire. All clients deemed high-risk based on the Part 1 screening questionnaire, and all low-risk clients with a reactive HIV screening test result from standard of care HIV testing at the clinic, will be offered enrollment in Part 2. It is expected that a minimum of 400

Part 2 participants, including 40 previously undiagnosed participants determined to be HIV-infected, should be enrolled annually at each clinical site in Part 2. For the base contract, the Contractor shall collect and store specimens from all Part 2 participants with at least one (1) reactive HIV screening test and 1000 participants with concordant negative results on all tests for future testing. The Contractor shall collect a short behavioral questionnaire from all participants in Part 2 and provide these data as described in Task 1.15 below. The contractor should plan for all Part 2 testing, data and specimen collection to be completed by two (2) months prior to the end of the 24 month base period to allow time for data and specimen transmission as part of contract close out.

Task 1.15: Transmit Part 2 Questionnaire Data to CDC. In the first six (6) months after IRB and/or OMB approval, the Contractor shall transmit data to CDC on a monthly basis; after this time the Contractor shall transmit the data on a quarterly basis. Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data. All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point. The Contractor shall ensure all consent information is 100% complete and Part 2 questionnaire data are 80% complete prior to submission to CDC.

Task 1.16: Transmit Part 2 HIV test results data to CDC. In the first six (6) months after IRB and/or OMB approval, the Contractor shall transmit data to CDC on a monthly basis; after this time the Contractor shall transmit the data on a quarterly basis. Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data. All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point. The Contractor shall ensure all data on test results (including standard of care results) is 100% complete prior to submission to

CDC.

Task 1.17: Identify and enroll Part 3 participants in serial follow-up. All Part 2 participants with a reactive result on one (1) or more but not all HIV tests under evaluation shall be enrolled in Part 3. It is expected that, of a minimum of 400 Part 2 participants enrolled at each clinical site, there should be a minimum of two (2) participants with early HIV infection identified in the first year. To ensure completion of follow-up in time for contract close out, Part 3 enrollment should end two (2) months prior to the end of the 24 month base period.

Task 1.18: Conduct follow-up with consenting Part 3 participants, including HIV testing and collection of specimens for storage and future testing. The complete follow-up schedule will involve return visits at 3, 7, 10, 14, 21, 28, 42, 56, and 70 days after the initial visit. The Contractor must include a plan for re-contacting participants who fail to return for a scheduled follow-up visit, and document how the plan was implemented when necessary. At each follow-up visit the contractor shall collect EDTA whole blood and Oral fluid specimens for same day testing with the HIV tests under evaluation. Additional specimens, including a minimum of 4ml of EDTA plasma, two (2) oral fluid collection tubes and DBS, will be collected from all Part 3 participants at each visit for storage and use in future HIV test evaluations. Participants enrolled in the follow-up study will receive a quantitative viral load after seroconversion with all HIV tests or at 70 days. The behavioral questionnaire will be collected from Part 3 participants again at the last follow-up visit.

Task 1.19: Transmit Part 3 Questionnaire Data to CDC. In the first six (6) months after IRB approval, the Contractor shall transmit data to CDC on a monthly basis; after this time the Contractor shall transmit the data on a quarterly basis. Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data. All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point. The Contractor shall ensure all consent information is 100% complete and Part 3 questionnaire data are 80% complete prior to submission to

CDC.

Task 1.20: Transmit Part 3 HIV test results data to CDC. In the first six (6) months after IRB approval, the Contractor shall transmit data to CDC on a monthly basis; after this time the Contractor shall transmit the data on a quarterly basis. Data shall be compiled in the required format as specified in Tasks 1.4-1.7 and transferred using the CDC Secure Access Management System (SAMS) to upload data. All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point. The Contractor shall ensure all performance data on test results is 100% complete prior to submission to CDC.

Task 1.21: Transmit Specimen repository data for Part 2 and Part 3 specimens to CDC. The database developed for Task 1.8 shall be maintained by the Contractor for the duration of the study. In the first six (6) months after IRB/OMB approval, the Contractor shall transmit data from this repository database to CDC on a monthly basis;

after this time the Contractor shall transmit the data after completion of follow-up with each Part 3 participant.

Data shall be compiled in the required format as specified in Tasks 1.4-1.8 and transferred using the CDC Secure Access Management System (SAMS) to upload data. All data collected through the time of transmission, including data transmitted previously, should be transmitted at each time point.

Task 1.22: Transmit Repository Specimens to CDC using appropriate containment for biohazard specimens, and ship frozen on dry ice. Once Part 1 data collection begins, the Contractor shall transmit to CDC all specimens collected and stored as part of Parts 2 and 3, including specimens collected during all pilot activities (1.12.1). The Contractor shall ship specimens to the CDC receiving address at six (6) month intervals according to the shipping protocols agreed upon under Tasks 1.3 and 1.5.

Task 1.23: Delivery of Final Report. The Contractor shall submit a final consolidated report by the expiration date of the contract. The final report shall include data on cumulative number of patients accepting enrollment into the study, number of persons tested and identified as HIV-positive and number of completed supplemental assays.

The format for the final report is the same as the monthly report and is attached in Appendix C provided as Attachment J-12, (See Section J, List of Attachments).

Task 1.24: Delivery of Final Datasets. The Contractor shall submit the final datasets by the expiration date of the contract. The datasets shall contain all data collected during the performance period including questionnaire data, HIV test results and specimen repository data. The Contractor shall also provide electronic copies of all source code, programs and documentation of programs used for analysis produced under this contract. The Contractor shall not retain any copies of data generated under the contract. During or after the life of the contract, no data may be released except after CDC approval. All requests which the Contractor receives from third parties for access to the data must be referred to the COR.

B. Option Period 2 and Option Period 3: Continued Enrollment in Parts 1, 2 and 3, with data collection and transmittal of data to CDC (Option Period 2 will be 24-48 months from date of Base award, Option Period 3 will be 48-72 months from date of Base Award). For the Option Periods, CDC may change the tests under evaluation depending upon the performance of the tests during the Base Period and the availability of new tests over time.

Task 2.1: Local IRB Renewal (within 12 months of completion of Task 1.9). The Contractor shall pursue and obtain renewal of local-site IRB approval to conduct the study annually. The Contractor shall deliver to CDC the IRB approval letter and a copy of the IRB-approved consent form with approval and date indicated. If required, the Contractor shall assist CDC in finalizing approval of a full OMB package for the data collection and shall not proceed with Tasks 2.4-2.14 until CDC staff advise that OMB approval has been obtained.

Task 2.2: Conference Calls. The Contractor shall coordinate and participate in twice monthly telephone conference calls with CDC to communicate progress. The Contractor shall provide draft minutes of each call and a list of action steps within two (2) business days of the call. CDC will respond with comments, and final minutes from each call will be submitted to the CDC COR within one (1) week of completion of the call.

Task 2.2.1: Monthly Progress Report. The Contractor shall provide CDC a monthly progress report two (2) business days before the last conference call of the month. The progress report shall include data on cumulative number of patients accepting enrollment into the study, number of persons tested and identified as HIV-positive and number of completed supplemental assays. The format for the progress report is attached as Appendix C provided as Attachment J-12 (See Section J, List of Attachments).

Task 2.3: CDC site visit. Within 90 days of award of an Option Period, the Contractor shall meet with CDC project staff to discuss the study successes and challenges and to allow CDC to directly observe implementation of the protocol at the study site. This meeting shall take place at the clinical site. The Contractor shall provide a draft agenda for CDC’s review approximately one (1) month prior to the site visit. Duration: 2-day meeting. The meeting shall be attended by the CDC staff, and Contractor key personnel. The Contractor shall provide to the CDC COR draft minutes from each CDC implementation site visit within one (1) week of completion of the site visit for CDC’s review.