RFP_2011-N-13417_Solicitation_Document.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 91

2. CONTRACT NO.

3. SOLICITATION NO.

2011-N-13417

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

HCVJB2X5-2011-96707

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

Centers for Disease Control and Prevention (PGO)

Acquisition and Assistance Branch 1

2920 Brandywine Road, MS E-15

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 6 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 2960 Brandywine Road, Stanford Bldg, Security Desk until 2:00 PM local time Aug 11, 2011

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

Jerry W. Outley

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

770-488-2831

C. E-MAIL ADDRESS

jmo4@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 44

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

X C DESCRIPTION/SPECS./WORK STATEMENT 3 X J LIST OF ATTACHMENTS 59

X D PACKAGING AND MARKING 20 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 21 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 22 X K OTHER STATEMENTS OF OFFERORS 60

X G CONTRACT ADMINISTRATION DATA 26 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 63

X H SPECIAL CONTRACT REQUIREMENTS 34 X M EVALUATION FACTORS FOR AWARD 86

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 25. PAYMENT WILL BE MADE BY CODE

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

RFP 2011-N-13417

SECTION B - Supplies Or Services And Prices/Costs

ITEM SUPPLIES / SERVICES/ QTY / UNIT ESTIMATED

COST

FIXED FEE TOTAL

EST. CPFF

0001 Evaluation of Rapid 1/Job HIV Self-Testing among MSM in High Prevalence Settings

SECTION C - Description/Specification/Work Statement

STATEMENT OF WORK

Title of Project: Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities

C.1 BACKGROUND AND NEED

Innovative testing strategies are needed to reduce levels of undiagnosed HIV infection and increase early access to treatment. The availability of a 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. Self-test HIV 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 several 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.

C.2 PURPOSE/PROJECT OBJECTIVE

The purpose of this contract is to assess the use and impact of rapid HIV self-testing among MSM located in up to three high HIV prevalence cities in the United States.

The primary research questions to be addressed by the contractor are:

1. Does provision of 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 goes 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 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 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 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 contractor shall recruit a minimum of 3,200 high-risk MSM who are HIV negative or of unknown serostatus, and a minimum of 300 HIV positive MSM (based upon self-report). (Using a binary outcome of success as having ≥3 HIV tests per year and the chi-square test at the 5% significance level, we have 90% power to detect a difference between the comparison and intervention groups if the success rates in these groups are 5% and 10% respectively. We inflated the sample size to allow for a maximum 40% attrition rate). Of these men, at least 20% shall be black MSM and 15% shall be Hispanic MSM to allow for appropriate analytical comparisons. To be eligible for the study, participants must be: MSM who are age 18 and over;

reside in the participating jurisdiction(s) proposed by contractor and approved by COTR; and report unprotected anal sex with more than one male partner in the past year. Recruitment of subjects shall begin approximately 18 months after award, depending on receipt of required approvals to begin research study. Recruitment of study subjects shall be completed within 9 months. An additional 14 months shall be used to complete the 12 month follow-up period for all subjects. Therefore, all research activities shall be completed within 4 years.

The research study will consist of three study conditions that are based on a participant’s disclosure of HIV status at time of enrollment. HIV negative and unknown status subjects shall be randomized to one of two study conditions: an intervention or comparison condition. HIV positive participants will not be randomized but assigned to a third study condition. The contractor shall recruit participants via the internet, and potentially other methods. The contractor shall develop and maintain a web-based system where interested participants will access a secure internet study specific website where screening, enrollment, consent, randomization and assessments will occur. In addition to conducting a baseline assessment, the contractor shall develop and maintain a web-based system where all participants complete follow-up assessments to be conducted at 1, 3, 6, 9, and 12 months after enrollment. The contractor shall provide participants with incentives following completion of each assessment so that the study will achieve an anticipated retention rate of 80% at each follow-up point. The contractor shall randomize the HIV-negative/unaware participants into two study arms after completing the baseline assessment. The contractor shall provide (mail or email) participants in the comparison condition with a resource page/brochure containing information on local HIV testing and other support services for MSM. The contractor shall provide participants in the intervention condition and all HIV-positive arm participants with up to 5 rapid test kits (by mail) and the resource brochure (by mail or email), upon request, at each assessment point. The contractor shall provide the option of requesting a kit that allows oral fluid collection or blood (finger-stick) collection. The contractor shall have a mechanism to assist person with preliminary positive results with counseling, referral, and assistance to accessing testing and care services. The contractor shall develop and maintain a web-based system where all persons who use the self-test kits can enter the result of the test and provide feedback on their experience with using the test kit. All persons who use the self-test kit, have a preliminary positive result, and contact the study counselor/referral coordinator by phone or email will be referred or if requested, provided assistance with linkage to local services by the contactor to a local site for appropriate follow-up testing and care services.

The study also includes a qualitative component to better understand how participants used the test kits, attitudes about self-testing, perceived benefits and drawbacks of self-testing, unintended consequences, and preferences for future program implementation. Five focus groups will be conducted in each participating city (k=15) with a total of approximately 50 men per city.

Participants assigned to the intervention arm will be invited to indicate their interest in participating in a focus group discussion after completing the 12 month survey. After a sufficient number of potential focus group participants have been accrued, study staff will randomly select a sample to follow-up to ascertain interest and availability. Contractor staff shall travel, as needed to each study city to conduct and record the face-to-face focus groups.

Other mechanisms for convening participants (e.g., online focus groups, conference calls or online chats) can be discussed. The contractor shall implement a mechanism to ensure focus group participation. The contractor shall record and transcribe discussions, enter the data into a qualitative software analysis program, and conduct analysis. A written summary of the qualitative findings, the analytic database, transcripts, and audio-recordings shall be supplied to CDC by the Contractor.

Specific objectives of the contract include the following:

1. Obtain and confirm required Institutional Review Board (IRB) and Office of management and Budget (OMB) approvals.

2. Design, develop and implement a secure study website to include a participant recruitment interface.

3. Develop and implement internet capable screening, enrollment, and consent procedures.

4. Develop and implement a web-based data collection system for all quantitative data activities (surveys and test results from self-test kits).

5. Develop and implement a participant tracking system which securely houses participant contact information (e.g., names, email address, mailing address, phone number), and automates reminder email notifications.

6. Develop and implement a confidential rapid HIV self-test kit and delivery system according to study protocol.

7. For persons testing preliminary positive, develop and implement a counseling, referral and linkage system protocol that includes supplemental testing.

8. Develop and implement a system to routinely monitor the progress of the accrual of study participants and make adjustments as necessary.

9. Conduct focus groups.

10. Produce interim and final progress reports.

11. Create and deliver semi-annual data sets and final data sets. Create and deliver a final report of the qualitative findings.

C.3 SCOPE OF WORK

The contractor will implement a three condition research study using a protocol developed by the contractor and approved by CDC. The study will assess the impact of providing rapid HIV self-test kits to MSM, coupled with phone-based counseling and referral to local testing and care services. Research activities shall be conducted in at least one, and up to three of the top 10 US jurisdictions with the highest HIV prevalence rates among MSM. In this study, CDC will not be engaged in counducting research activities and CDC staff will not have access to personal identifiable information. Therefore, CDC IRB will not be obtained. This study will identify and quantify the use of the HIV self-test kits, changes in sexual behaviors, changes in HIV testing practices, and the use of phone-based counseling, supplemental testing and linkage to care. The contractor shall produce a final report and final dataset to be submitted to CDC at the end of the contract.

C.4. Technical Requirements

SPECIFIC TASKS TO BE PERFORMED

The contractor shall provide all labor, equipment, materials, and supplies to accomplish the following tasks:

Task 1. Develop research protocol and develop procedures The contractor will develop the research protocol and provide it to the COTR. The contractor will revise the protocol to meet COTRs requirements. The contractor will develop procedures to carry out the three condition research study.

Task 2. Obtain required approvals The contractor will obtain documentation of all required protocol approvals (e.g., local IRB and, if required, documentation that OMB approval has been obtained) before initiating participant recruitment into the research project.

Subtask 2.1 The contractor will secure approval for the research project from the appropriate local Institutional Review Board (IRB) when necessary.

Subtask 2.2 If Office of Management and Budget (OMB) clearance is required, the contractor shall confirm OMB clearance with the COTR prior to implementation of the data collection system. OMB clearance is required for non-clinical research trials whenever the Federal Government is collecting data or sponsoring the collection of data from 10 or more individuals/respondents using a standardized data collection instrument.

Task 3: Develop Recruitment and Retention Materials and a Recruitment/Study Information Website

Subtask 3.1 The contractor shall develop mock-ups of any recruitment materials (e.g. banner advertising, flyers, and brochures) and use market research methods to ensure recruitment materials are acceptable to the target population. Recruitment materials shall be submitted to the COTR for final approval.

Subtask 3.2 The contractor shall develop and house a recruitment/study information website where participants can access/enroll in the study and can access information about the study, additional HIV testing services in the three local areas, and information on how to proceed once they obtain a result from the rapid HIV self test. Web page mockups shall be submitted to the CDC COTR for approval no later than 3 months after completion of the CDC Certification and Accreditation (C&A) process (see Subtask 4.2).

Subtask 3.3 The contractor shall develope materials provided to or accessed by study participants in both English and Spanish, other than materials specified in Section V.

Government provided property/materials.

Subtask 3.4 The contractor shall develop and implement a plan to provide existing health-related information to study participants upon request. The information shall be in an electronic format and emailed to subjects two to seven days before each assessment/questionnaire.

Task 4. Identify a Web-Based Platform for data collection The contractor shall select a secure and appropriate platform (e.g., IBM SPSS Data Collection (MR Interview), SurveyGizmo) for developing and hosting the web-based survey instrument.

The platform shall be administered by the contractor in a centralized location and shall include the following functions: creation and implementation of a web-based survey instrument/questionnaire; process and analyze data; and generate datasets and reports. The contractor shall obtain all necessary software licenses and comply with the information technology hardware requirements specified by the manufacturer of the selected platform.

Subtask 4.1 The contractor shall identify the platform no later than 3 months after award in the form of a technical report to the COTR. The document shall be in Microsoft Word format, no more than 10 pages in length, and describe the recommended platform, including a justification of the selection and technical specifications.

Subtask 4.2 Complete Certification and Accreditation (C&A) Process: The platform shall comply with all Federal and Health and Human Services (HHS) Information Security Program policies and requirements as described under “Special Considerations”. The contractor will be required to complete the CDC Certification and Accreditation (C&A) process for the web-based platform prior to data collection. The C&A process shall be conducted in collaboration with CDC and ensure information security requirements have been met.

Subtask 4.3 Program Web-Based Data collection Instruments (eligibility screener, baseline and follow-up instruments/questionnaires, and forms to assess use and experience of rapid self-test kits): The contractor shall program web-based data collection screener (maximum 30 elements/questions), and baseline and follow-up assessments (questionnaires) with no more than 100 elements/questions, which shall take, on average, less than 30 minutes to complete. Data collection instruments (questionnaires) shall be provided by the COTR (see section - Government Furnished Property). The screener shall include questions to determine study eligibility. The baseline and follow-up questionnaire shall include questions related to HIV risk behaviors, HIV testing experience and result, use of self-test HIV kits and results, and use of supplemental testing services, prevention programs, and care and treatment services. The rapid self-test result and experience instrument will allow all users to provide feedback on the use of the kit. This assessment will have up to 15 elements/questions. The contractor shall identify and address relevant technical considerations for web-based survey implementation. Such considerations shall include look-and-feel issues, layout, number of questions per page, and accessibility.

Subtask 4.4 The web-based survey instrument shall be programmed by the contractor to operate in at least one, and up to three of the top 10 US jurisdictions with the highest HIV prevalence rates among MSM. The contractor shall determine the required locations based on study recruitment requirements. The contractor shall create web page mockups of the survey. Web page mockups shall be submitted to the CDC COTR for approval no later than 3 months after completion of the C&A process.

Task 5. Develop and implement an HIV rapid test kit delivery and tracking system The contractor shall provide at least two types of rapid HIV test kits to ensure that participants can request kits that can be used with oral fluid collection and a different kit for blood (finger-stick and/or lancet for dry blood spot) collection only. The contractor shall mail rapid HIV test kits to participants in the intervention arm and in the HIV-infected study arm at each follow-up point, based on participant’s request. The contractor shall ensure that participants in the intervention and HIV-positive arm can request up to 5 kits at each assessment. The contractor shall offer to mail all study subjects up to five self-test kits of the participant’s choice, and a dry blood spot collection kit at the completion of the 12 month assessment. The contractor shall ensure that all HIV self-test kits are mailed with at least a 6-month shelf life remaining.

Subtask 5.1 The contractor shall keep a log of the kit lot numbers, the number and unique identifier of each self-test kit distributed to each participant.

Subtask 5.2 The contractor shall monitor the progress of the delivery and tracking system by submitting a semi-annual report based on criteria described in but not limited to Subtask 5.1.

Subtask 5.3 The contractor shall develop and implement an anonymous web-based system for all persons, who used study self-test kits and voluntarily want to report their results.

Subtask 5.4 The contractor shall distribute a dry blood spot collection kit at the 12-month assessment with instructions for self administering and addressed stamped mailers for sample to be returned to contractor. The contractor will store the dry blood spot cards according to specifications from the CDC laboratory and deliver them at the end of the study along with the final datasets (see Subtask 9.5).

Task 6. Identify or develop a mechanism to provide an effective phone-based counseling, referral, and linkage to care service to all persons who report a preliminary positive rapid test result or who report being HIV positive but are not currently in care.

Subtask 6.1 Establish and manage a phone based counseling service. The contractor shall establish and manage a toll-free (800) study phone number. The phone number shall be available on the study website and provided with each self-test kit. All persons who use the self-test kits will be able to call and obtain counseling and assisted referral after reading their results.

Information on where to obtain supplemental testing and health care services in the geographic location will be available by phone and on the study website.

Subtask 6.2 Link self-testers with reactive tests to care The contractor will be required to report the number of users of the kits provided through this study with a reactive test that were linked to care. In this context, “linked to care” will be defined as “first visit with a prescribing provider”. If the contractor does not have the capacity to provide HIV supplemental testing and linkage services in the proposed jurisdictions, the contractor may recruit local health departments and/or AIDS service organizations. The contractor shall determine the best method to link their phone based counseling service (subtask 6.1)the testing, linkage services and/or medical services available at the local level that will allow at least 85% linkage to care among self-testers with reactive results. If needed the contractor may conduct one visit to each participating jurisdiction to have face-to-face meetings with staff employed by the local health departments and/or AIDS service organizations.

Subtask 6.3 Develop literature materials to be included with each self-test kit. Material (e.g., brochure) will have brief information on the study, web links or phone (800) number to call for further information and counseling after the self-test has been used. Such materials shall be submitted to the COTR for final approval.

Task 7. Conduct the approved research project Using the CDC approved research protocol, the contractor shall recruit and follow the specified study populations and ensure completion of required data collection. The Contractor shall implement the projection up to three of the top 10 US jurisdictions with the highest HIV prevalence rates among MSM with the highest HIV prevalence among MSM to ensure sufficient access to the proposed study population. For this study the contractor shall recruit a minimum of 3200 MSM subjects who report that they are HIV-negative or have not received an HIV test result (unaware of their HIV status) into a two study condition randomized control trial, and an additional 300 HIV positive MSM subjects into a third non-randomized study condition. At least 20% of the sample shall be black MSM and 15% Hispanic MSM, to allow for analytical comparisons.

Subtask 7.1 Selection of recruitment and retention methods The contractor shall determine which recruitment and retention methods are most effective at reaching MSM. Recruitment and retention methods must reflect the interests of the target population while meeting an acceptable public health promotion goal. The contractor shall identify any barriers to recruiting and retaining specific sub-groups of MSM and ensure recruitment and retention methods address such barriers. The contractor shall determine the feasibility of using available demographic or geographic data for targeted recruitment; the contractor shall make recommendations to CDC on how this information may be used to improve recruitment and retention activities. If using web based recruitment, the contractor shall assess the acceptability and usability of web-page mockups with the target population using market research methods. The contractor shall work with operators of the web sites to purchase any necessary advertising space for recruitment activities and ensure recruitment activities meet web site operators’ advertising guidelines. The contractor shall provide a detailed report to CDC on the recruitment and retention methods to be used during the initial phase of the project. The purpose of the report is to ensure that the contractor’s approach will adequately capture a diverse sample of MSM. The report shall be in Microsoft Word format and not exceed 40 pages (including appendices).

Subtask 7.2 Data collection shall be web-based so that it can be completed using the internet, smart-phones, or similar mechanism. Data to be obtained shall include basic demographic information, HIV testing history and results, number of sex partners, infection status of partners, number of unprotected sex events, use of self-rapid tests by subject and partners, adverse events following use of rapid test kit, and use of supplemental testing and HIV-related health care services. Reporting periods for questions shall vary from 1 month to 12 months. The CDC COTR will provide all data collection instruments (i.e., screener, baseline and follow-up questionnaires, and self-test use experience questionnaire) to the contractor within 3 months of award of contract.

Subtask 7.3 The contractor shall collect data from participants at screening/recruitment, and at follow-up assessments at 1, 3, 6, 9, and 12 months after enrollment. The contractor shall also collect data from all persons who use self-test kits and voluntarily report such use and result through the website.

Subtask 7.4 Monitor the progress of the recruitment, retention and data collection system quarterly: The contractor shall submit a quarterly progress report that will monitor recruitment, retention and completion to the COTR via a written document. The report shall document the overall progress for recruitment by HIV status and race/ethnicity and the overall retention status by each study condition. The purpose of the quarterly report is to ensure data accrual in the past 3 months is proceeding at a pace consistent with the planned sampling interval, to identify any problems in recruitment, and to make timely adjustments in recruitment methods in order to address these problems. The report shall be in Word format and not exceed 50 pages (including appendices). If study recruitment during the first 3 months of recruitment is less than required, the contractor shall conduct market research to enhance recruitment and develop appropriate recommendations. After COTR approval has been granted, the Contractor shall modify data collection methods and document all changes implemented. The contractor shall monitor the recruitment process and continue market research activities, as needed, to ensure the study recruitment is completed within 9 months of initiation of recruiting subjects into the study.

Subtask 7.5: Implement Data Collection System The contractor shall be responsible for implementing and supporting the web-based data collection system for up to 4 years. Implementation shall begin no later than 18 months after the award. The contractor shall collect a maximum of 21,000 (3500*6 assessments) completed surveys of MSM during the contract period. Incorporating a retention rate of approximately 80%, the actual number of assessments shall be approximately 17,500, unless contractor recruits additional subjects. Data shall be collected based on the sampling intervals identified in Subtask

7.3 and approved by the COTR.

Subtask 7.6: Implement Reimbursement System The contractor shall be responsible for implementing a reimbursement system consistent with the approved protocol for all persons who complete assessments.

Subtask 7.7 Conduct in-person and/or online Focus Groups The contractor shall be responsible for implementing the focus group activity in year 3. Five focus groups of approximately 90 minutes in duration shall be conducted in each participating city with a range of 7 to 15 participants in each focus group. Participants assigned to the intervention arm shall be invited to participate in a focus group discussion after completing the 12 month survey. After a sufficient number of potential focus group participants have been accrued, the Contractor shall randomly select a sample to follow-up to ascertain interest and availability. The contractor staff shall conduct and record the face-to-face focus groups. The discussion guide with no more than 10 topics/themes will be provided by CDC. The contractor shall develop and implement a recruitment and participation strategy to ensure required focus group participation. The Contractor shall record and transcribe discussions, enter the data into a qualitative software analysis program, and conduct analysis. A written summary of the qualitative findings (no more than 20 pages), the analytic database, transcripts, and audio-recordings shall be delivered to CDC.

Task 8: Develop Monitoring/Progress Plan The contractor shall develop a plan to monitor the progress of critical project deliverables and milestone achievements: see table of deliverables/milestones. The plan will be approved by CDC project staff prior to implementing the research project.

The progress plan shall identify problems that would compromise the web-based system’s ability to collect data (e.g. decreased participation rates from specific sub-populations of MSM across time or technological changes that affect recruitment) or the distribution of self test kits or the linkage to care, and work to quickly resolve them.

The contractor must consider both quantitative methods (e.g., programming routines and tables in SAS) and qualitative methods (including plans for focus group or other market research methods) in this plan to follow up on any potential recruitment or distribution problems. When such problems are identified, the contractor shall make recommendations to CDC for adjusting recruitment or delivery methods if necessary.

Once the research project is implemented, the progress plan shall incorporate the monitoring of the recruitment, retention and data collection systems as described in task 7.4.

Minimum progress report requirements are:

• Obtaining data from website operators on number of ad impressions per month or number of instant messages sent by website operators to their members (if any of these recruitment methods are used).

• Providing click-through rates, number completing eligibility screener, number consenting, number completing portion of survey, number of completed surveys.

• Among persons completing the eligibility screener, provide a breakdown of reasons for not being eligible to participate

• Providing participant characteristics through the use of detailed tables, including:

o Race/ethnicity o Age o HIV status o Geographic area

• Providing number of self test kits mailed by study arm

• Identifying frequency of missing data for each survey item

• Provide cumulative amounts of paid incentives

• Additional items

The contractor shall use the Progress Reports to communicate key findings and recommendations or action steps for system improvement. Minimum progress report requirements, outlined above, shall be completed every 3 months and can be used as a guide to update CDC COTR on progress during conference calls.

The format for the progress reports shall be as follows:

• Project description

• Summary of activities performed

• Results (i.e., the number of subjects recruited by race/ethnicity, HIV status, retention rates, test kits mailed by study condition, number of subjects linked to care, etc).

• Challenges/Issues

• Next Step(s)

Task 9. Consultations, data sets and reports to COTR

Subtask 9.1 Kick-off meeting: Travel to Atlanta, Georgia for a two day meeting with the CDC COTR, dates to be determined by CDC, to conduct introductions, obtain contact information, and address initial start up questions. CDC shall provide the meeting agenda. The contractor shall provide the COTR with meeting minutes within 7 business days of the kick-off meeting.

Subtask 9.2 Consultations: The contractor shall update CDC on progress during bi-monthly one hour conference calls. The conference call schedule may be reduced to monthly calls during the recruitment and follow-up phase of the project at the discretion of the COTR. The contractor shall provide the agenda prior to the call. The contractor shall provide the COTR with meeting minutes within 7 business days of the call.

Subtask 9.3 Quarterly progress reports: Reports shall be provided as indicated in Task 7 and Task 8. The format of the progress reports will be as specified in Task 8.

Subtask 9.4 Interim data sets: The contractor shall submit all data collected to the COTR at 6 month intervals after initiating study recruitment.

Subtask 9.5 Final data set: The contractor shall submit a final cleaned data set to the COTR at completion of the study. The contractor shall also provide electronic and paper copies of all source code, programs and documentation of programs used for analysis, data runs or other development process to CDC for all systems produced under this contract. For the focus group component, the contractor shall supply CDC the analytic database (including coding), electronic transcripts, and audio-recordings.

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 COTR.

Subtask 9.6 Final report: As specified in Task 8.

C.5 REPORTING SCHEDULE –

The contractor shall prepare monthly reports to describe all project-related activities, accomplishments, risks, issues, work plan reports, and costs incurred.

C.6 SPECIAL CONSIDERATIONS –

Security Compliance

Information Security is applicable to this solicitation as all information systems developed, operated or used by or on behalf of the Federal Government must comply with Federal Information Security laws, policies and standards. The following information is provided to assist in the preparation of proposals.

OMB Circular A-130 (http://www.whitehouse.gov/omb/Circulars_a130_a130trans4/) establishes policy for the management of Federal information resources, pursuant to a number of laws and regulations, including the Paperwork Reduction Act of 1980 (amended in 1995), the Computer Security Act of 1987, and other laws. Circular A-130 requires all federal information systems to have security plans, emergency response capabilities, designated individuals who are responsible for security, reporting to Congress, security awareness training, and regular review of the system. Appendix III of Circular A-130, entitled “Security of Federal Automated Information Resources,” establishes a minimum set of controls to be included in Federal automated information security programs; assigns Federal agency responsibilities for the security of automated information; and links agency automated information security programs (such as the DHHS AISSP) with OMB Circular No. A-123.

The Federal Information Security Management Act of 2002 (P.L. 107-347) (FISMA) (http://csrc.nist.gov/policies/FISMA-final.pdf) requires each agency to develop, document, and implement an agency-wide information security program to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor (including sub-contractor), or other source.

The National Institute of Standards and Technology (NIST) has issued a number of publications that provide guidance in the establishment of minimum security controls for management, operational and technical safeguards needed to protect the confidentiality, integrity, and availability of a Federal information system and its information.

This Statement of Work (SOW) requires the successful offeror to (1) develop, (2) have the ability to access information from, or (3) host and/or maintain a federal information system(s).

Pursuant to Federal and HHS Information Security Program Policies the following standards and guidelines apply:

• FIPS Publication 200, Minimum Security Requirements for Federal Information and Information Systems (http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf),

• FIPS Publication 199, Standards for Security Categorization of Federal Information and Information Systems (http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf)

• NIST Special Publication 800-18, Guide to Developing Security Plans for Federal Information Systems (http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18- Rev1-final.pdf)

• NIST Special Publication 800-60, Guide for Mapping Types of Information and Information Systems to Security Categories Vol. 1 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf) and Vol. 2 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf).

• NIST Special Publication 800-53, Recommended Security Controls for Federal Information Systems and Organizations (http://csrc.nist.gov/publications/nistpubs/800- 53-Rev3/sp800-53-rev3-final-errata.pdf).

• NIST Special Publication 800-63, Electronic Authentication Guideline (http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf)

Privacy Compliance Contractor shall abide by all requirements of the Privacy Act of 1974. Pursuant to those requirements, the web-based data collection system for the evaluation of rapid HIV self-testing among MSM in high prevalence settings shall become part of CDC’s Privacy Act System of Records Notice. Contractor shall conduct and maintain an initial Privacy Impact Assessment (PIA) as defined by Section 208 of the E-Government Act of 2002. Periodic reviews shall be conducted by the system owner, with assistance from the contractor, to determine if a major change to the system has occurred, and if a PIA update is needed.

The contractor shall inform its workforce (employees and subcontractors it retains for staff augmentation purposes) of the sensitive non-public nature of the data collection system and shall limit access to employees and subcontractors based on need to know principles. These principles shall be based upon theories of least privileges and minimum necessary, as set out in current NIST Publications.

Additionally, the contractor shall identify any subcontractors to the CDC contracting office and shall require its subcontractors to comply with the same legislation, regulations, related guidance, and the objectives of CDC and the Department (including the terms and conditions set forth in this agreement) regarding the protection of this data collection system.

Information System Security Plan The offeror must include a draft information system security plan (SSP) using the current template in Appendix A of NIST SP 800-18. Based on guidance in FIPS 199 and NIST SP 800- 60 (information type D.14.2), web-based data collection system for the evaluation of rapid HIV self-testing among MSM in high prevalence settings project shall be assigned an overall security category (SC) of MEDIUM based on (confidentiality, MEDIUM), (integrity, MEDIUM), and (availability, MEDIUM) impact levels. Therefore, details contained in the offeror’s draft SSP shall include NIST SP 800-53 security control baselines for high impact systems.

The resultant contract shall require the draft SSP to be finalized in coordination with the COTR no later than 90 calendar days after contract award. Also, a contractor is required to update and resubmit its SSP to CDC every three years following award or when a major modification has been made to its internal system.

The contractor shall allocate staff, and specify a budget line item, for maintaining computer and data security on the contract, and for maintaining the SSP and completing the necessary additional documents to obtain Certification and Accreditation. Those documents included are listed below. Templates of the documents shall be provided to the contractor after award.

• Baseline System Information (BSI)

• Privacy Impact Assessment (PIA)

• Host Characterization Worksheet (HCW)

• System Security Plan (SSP)

• Security Baseline Worksheet (SBW)

• Business Continuity Plan (BCP)

• Risk Assessment Report (RAR)

Position Sensitivity Designations and Non-Disclosure Agreements The following position sensitivity designations and associated clearance and investigation requirements apply under this contract: Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC, MBI or LBI). Contractor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a National Agency Check and Inquiry Investigation plus a Credit Check (NACIC), a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

Upon award, the contractor shall be required to submit a roster of all staff (including subcontractor staff) working under the contract that shall develop or have the ability to access information from the web-based HIV behavioral trend analysis among MSM project. The roster shall be submitted to the COTR, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. The Contracting Officer shall notify the contractor of the appropriate level of suitability investigations to be performed. An electronic template, “Roster of Employees Requiring Suitability Investigations,” is available for contractor use at: http://ais.nci.nih.gov/forms/Suitability-roster.xls

Upon receipt of the Government’s notification of applicable suitability investigations required, the contractor shall complete and submit the required forms within 30 days of the notification.

Contractor and subcontractor employees who have met investigative requirements within the last five years may only require an updated or upgraded investigation.

Each contractor/subcontractor employee who may have access to information under this contract shall complete the “Commitment to Protect Non-Public Information – Contractor Agreement”.

A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the

COTR.

The following apply to contractor/subcontractor employees associated with the web-based data collection system for the evaluation of rapid HIV self-testing among MSM in high prevalence settings project:

1) Personnel may not begin work under the contract until the contractor has submitted the employee roster and non-disclosure agreements as described above.

2) Personnel without necessary background investigations shall not have access to sensitive project data.

3) Violation of these conditions may lead to termination of the contract.

Offeror’s Official Responsible for Information Security The offeror shall include in the “Information Security” part of its Technical Proposal the name and title of its official who will be responsible for all information security requirements should the offeror be selected for an award.

Rules of Behavior The contractor/subcontractor employees shall comply with the HHS Information Technology General Rules of Behavior.

Information Security Training HHS policy requires that contractors and subcontractors shall receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The successful offeror shall be responsible for assuring that each contractor and subcontractor employee has completed the HHS Computer Security Awareness Training course (or another course designated by CDC) prior to performing any contract work, and thereafter completing the HHS-specified annual refresher course during the period of performance of the contract.

The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COTR.

Encryption All sensitive data from the web-based HIV behavioral data collection system among MSM stored on desktop computers used on behalf of HHS shall be secured either through a FIPS 140-2 compliant encryption solution or through adequate physical security and operational controls at the…