Solicitation_2013-N-15662.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 66

2. CONTRACT NO.

3. SOLICITATION NO.

2013-N-15662

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

07/02/2013

6. REQUISITION/PURCHASE

NO.

HCVJB2X5-2013-56653

7. ISSUED BY CODE 2543 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

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 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 until 2:00p local time 08/05/2013

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

Sherrie N. Randall

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2866

C. E-MAIL ADDRESS

srandall@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 37

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 46

X D PACKAGING AND MARKING 15 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 16 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 17 X K OTHER STATEMENTS OF OFFERORS 47

X G CONTRACT ADMINISTRATION DATA 21 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 51

X H SPECIAL CONTRACT REQUIREMENTS 26 X M EVALUATION FACTORS FOR AWARD 63

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 2543 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

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

0001 Video Development and Beta testing Service for a waiting room-delivered video to enhance antiretroviral therapy (ART) readiness and adherence and retention in care for HIV-positive minority persons

1 Job $_________ $_________

0002 Travel

1 Job $________ $_________

Section C - Description/Specification/Work Statement

I. Background and Need

Research findings from the HIV Prevention Trials Network HPTN052 study published in 2011 concluded that HIV-positive men and women could reduce their risk of transmitting the virus to their sexual partners by 96% when taking oral antiretroviral therapy (ART) [1]. The study also found that receiving treatment earlier in the course of HIV infection reduced the incidence of HIV-associated opportunistic infections.

These results represent the strongest evidence to date that early HIV treatment dramatically reduces the chance that an HIV-positive individual will transmit the HIV virus to a sexual partner. Additional research also indicates that improved treatment readiness and adherence to ART among HIV-positive persons are critical components for successful treatment and prevention outcomes [2]. Early initiation of treatment and high levels of adherence have been shown to be positively associated with decreased plasma viral load levels, increased CD4 cell counts, and decreased mortality [3]. Sub-optimal adherence is significantly associated with negative outcomes and also may lead to viral resistance and limited future treatment options. Studies have shown that delays in treatment initiation and even short time periods of non-adherence among HIV-positive persons on therapy are associated with an increased risk of treatment failure, including viral breakthroughs, lower CD4 cell counts, and increased mortality [4]. Thus, early initiation of therapy and consistent adherence to medication are necessary for sustained viral suppression and optimal health outcomes. However, only 40% of HIV-positive persons linked to care are on antiretroviral therapy [5], and 28% of all persons living with HIV in the United States have sufficient viral suppression [6]. Actual adherence levels are often low and tend to decline over time. The ability of patients to initiate and adhere to a rigorous and complex ART treatment regime is challenging. There are many reasons for failing to initiate treatment or adhering to a precise and consistent medication schedule that is needed for treatment to be successful. Factors shown to influence treatment readiness and decrease adherence include a patient’s comprehension of their HIV infection and treatment recommendations, health beliefs associated with the benefits of therapy, fears or ambivalence about starting treatment, dosing/regime barriers (e.g., dosing complexity, pill burden, dietary restrictions, side effects), psychiatric/co-morbidity factors (e.g., alcohol abuse, substance use, depression, anxiety, hopelessness), cognitive factors related to treatment competency (e.g., knowledge, attitudes, and beliefs about treatment effectiveness and benefits, treatment self-efficacy), daily schedule issues (e.g., too busy, inconvenient), and lack of social or provider support.

The Centers for Disease Control and Prevention’s (CDC) Compendium of HIV Prevention Interventions with Evidence of Effectiveness has identified 8 intervention programs that have demonstrated varying levels of efficacy for improving ART-related outcomes among HIV-positive persons [7]. These programs included six educational/behavioral interventions to improve ART adherence, and two Directly Administered Antiretroviral Therapy (DAART) interventions. All of these interventions are delivered in individual- or small group-level formats and require considerable resources to implement and substantial time commitments from clients. As a result, there is a significant need for treatment readiness/adherence interventions that can be brought to scale quickly, provide maximum coverage, and be sustained at relatively little cost. The development of a video-based structural intervention through this contract directly supports CDC’s High-Impact HIV Prevention framework [7].

The Patient Protection and Affordable Care Act (ACA) is poised to bring millions of uninsured people – including many HIV-infected minority persons – into the health care system when it is implemented in 2014. Clinical settings may be increasingly more dependent on adopting simple, low-cost, low-intensity waiting room delivered interventions, which can be administered with minimal staff time as part of routine clinical services, to supplement more intensive but effective interventions that require additional patient or staff time to implement. Stand-alone video-based interventions have been found to be efficacious, low-cost, and require limited staff time or training. In a study to evaluate the Safe in the City video intervention, CDC scientists and external colleagues found that showing a brief informational and skills-building video, without a counseling component, in STD clinic waiting rooms decreased new sexually transmitted infections among at-risk patients in three urban clinics by approximately 9% [8]. As has been shown with other video-based interventions conducted in other settings with varying health outcomes

(e.g., tobacco cessation and proper antibiotic use), the video-based approach has the potential to reach large numbers of clinic patients efficiently and at low cost. The stand-alone video-based approach focusing on encouragement of ART among treatment-naïve patients and ART adherence among HIV-positive patients in treatment may prove to be an important prevention tool in achieving goals of the National HIV/AIDS Strategy, such as improving health outcomes for persons living with HIV/AIDS and reducing HIV-related disparities and health inequities.

This video also could be a key product to assist CDC’s prevention efforts with HIV-positives. In addition, this video will have broad applicability beyond CDC’s Division of HIV/AIDS Prevention (DHAP) and should be feasible, practical, and cost-effective to extend to virtually all medical care settings across the U.S. that provide HIV medical care to HIV-positive persons, including Health Resources and Services Administration-funded grantees, Veterans Administration-funded clinical care sites, and all private HIV treatment and care clinics.

II. Purpose/Project Objectives

The purpose of this contract is to develop, beta-test, and refine a brief, video-delivered, waiting room intervention that promotes early initiation of ART among treatment-naïve HIV-positive patients, adherence to ART and retention in care among HIV-positive patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and patient-initiated discussion of these topics with their providers for CDC-DHAP. This video could be an asset to CDC’s prevention efforts with HIV-positive persons.

Specific objectives of the contract include the following:

1. Develop a draft theory-based, brief, video-delivered waiting room intervention that promotes early initiation of ART among treatment-naïve clients, adherence to ART and retention in care among HIV-positive patients currently on therapy, and sexual risk reduction tailored to HIV-positive minority persons.

2. Develop “movie style” posters to enhance viewership and a User’s Guide to improve the integration of the video into HIV/AIDS treatment facilities.

3. Conduct a beta-test of the draft video intervention in up to four HIV/AIDS treatment facilities meeting specific programmatic criteria.

4. Document the feasibility and use of this intervention during routine clinical care.

5. Collect observational data and supplemental patient-level medical record data from participating treatment facilities as part of the beta-test of the draft video intervention.

6. Refine the draft video intervention based on analysis of the patients’ reactions.

7. Produce interim and final progress reports.

8. Create and deliver interim data sets and final data sets.

III. Scope of Work

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, facilities, supplies, materials and equipment to develop, beta-test, and refine a brief video intervention for minority HIV-positive persons attending HIV/AIDS treatment facilities. The format of the video shall be multiple interwoven vignettes that incorporate key information and prevention messages aimed at increasing treatment readiness, ART adherence, retention in medical care, and risk reduction and partner protection. CDC will provide learning objectives, a list of issues to address, and coping strategies to recommend (see Attachment A). The vignettes shall depict characters of varying backgrounds and ethnicities to appeal to a diverse clinical audience. The video shall be based on an integrated theoretical approach to achieving health behavior change, including peer support and cognitive-behavioral approaches. The video shall be designed to play on television monitors in HIV/AIDS treatment facilities. The draft video intervention shall be beta-tested in HIV/AIDS treatment facilities meeting specific programmatic criteria. Assessment of reactions to the video intervention shall use systematic observations and supplemental medical record data from all patients visiting the treatment facilities. Medical record data will cover the 10-month beta-test period and the 10-month period immediately prior to the beta-test. The contractor shall produce a refined video, supporting materials, and final report, to be submitted to CDC and the end of the contract.

IV. Technical Requirements

Specific Tasks to Be Performed The contractor shall perform the following tasks:

Task 1. Kick-off Meeting

Travel to Atlanta, Georgia for a 2-day meeting with the CDC Contracting Officer Representative (COR), dates to be determined by CDC, to conduct introductions, obtain contact information, address initial start-up questions, clarify technical requirements of the video intervention, discuss assessment methods for the beta-test, and discuss proposed methods for identifying potential problems and handling them. CDC will be responsible for the kick-off meeting agenda and notes.

Task 2. Beta-test Facilities

Identify and select up to four HIV/AIDS treatment facilities to participate in the beta-test of the draft video-based intervention and submit the selections in a report to the COR for review and approval. Each treatment facility shall meet the following criteria:

1) located in different jurisdictions with high AIDS prevalence;

2) managing >500 unique HIV-positive patients annually;

3) serving minority persons such that minimally 70% of the clinic population is African American and Latino;

4) <75% of patients have suppressed viral load;

5) utilizing an electronic medical record system; and

6) not participating in another behavioral intervention research project.

The four treatment facilities shall have a combined total of at least 2,700 monthly patient visits during the beta-test period. The four treatment facilities shall show the video throughout each clinic day during the beta-test period so that all patients in the facility’s waiting room shall be exposed to the video. However, treatment facilities shall have the option to tailor intervention delivery to reduce potential client and staff-level intervention burnout where appropriate.

Video Development

Task 3. Input on Format and Content

Design the video to complement ART initiation (e.g., treatment readiness and benefits of treatment) and adherence messages provided by clinicians and to support other interventions that promote ART-specific outcomes. The video format shall be a series of vignettes depicting characters of varying backgrounds and ethnicities (African American, Latino/Latina, MSM, heterosexual men and women). The vignettes shall address various issues related to treatment readiness and adherence, retention in medical care, and risk reduction and partner protection (see Attachment A). Health messages delivered by the video shall employ a combination of proven scientific approaches, including peer support and cognitive-behavioral approaches such as increasing knowledge; addressing beliefs, attitudes, benefits, perceptions of ART use and effects; enhancing self-efficacy and skills to initiate and adhere to treatment regimens; and addressing other potential barriers to optimal treatment outcomes such as unmanaged mental health issues or substance abuse. The contractor shall design the video to play on television monitors in the waiting rooms (or exam rooms) of HIV/AIDS treatment facilities in the United States. The total length of the video shall correspond to typical clinical wait times (e.g., <30 minutes), which shall be determined early during the intervention development phase. Develop up to two short animation sequences to reinforce key messages imparted by the video’s dialogue.

Present the format and content of the video-based intervention in a report to the COR for review and approval.

Task 4. Draft Storylines Develop draft storylines and separate the storylines into different scenes to be included in the video. Determine how the theory-based framework and prevention messages should be appropriately incorporated into each scene. Develop and draft storylines for up to two animation sequences. Submit the draft storylines to the COR for review and approval.

Task 5. Final Storylines

Finalize video storylines based on COR feedback and submit to the COR for final review and approval. This process shall require up to three iterations.

Task 6. Draft Script

Draft the video script and submit it to the COR for initial review and approval.

Task 7. Revised Script

Submit revisions of video script for COR approval. This process shall require up to four iterations.

Task 8. Video Production Schedule

Submit draft and final versions of the video production schedule to the COR for review and approval.

Task 9. First Video Rough Cut

Produce the first rough cut of the video. Retain all unused film until after refinement is completed.

Submit to the COR for review and approval.

Task 10. Revised Video Rough Cuts

Incorporate COR feedback in revision of the rough cuts. Submit the video rough cuts to the COR for review and approval. This process shall require up to three iterations.

Task 11. Video Fine Cuts

Submit the video fine cuts to the COR for review and approval. This process shall require up to two iterations.

Task 12. Spanish Translation

Translate the script of the fine cut into Spanish that is free of colloquialisms and that can be understood by native Spanish-speakers from Mexico and Puerto Rico and submit to the COR for review and approval. This process shall require up to three iterations.

Task 13. Playback Options and Captions

Incorporate multiple playback options and open-captions in the video and produce versions with English and Spanish open-captions. Use of English and Spanish language open-captions will maximize viewership by the hearing impaired or Spanish-speaking persons. As required as a condition of HHS approval, the videos will be captioned to be compliant with Section 508(c) of the Americans with Disabilities Act. The videos will be open-captioned. The captions will be 100% accurate as to the words spoken in the video. Auditory information necessary for the comprehension of the content of the video will be captioned, but all other on- and off-screen sounds will not be noted in the captions.

Task 14. Posters

Design and produce four “movie style” posters to be displayed in waiting rooms and exam rooms of participating facilities. One shall direct patients’ attention to the video, and three shall reinforce key messages imparted by the video. The posters shall include images from the video and select URLs for further information on HIV/AIDS prevention and treatment. English and Spanish versions of each poster shall be produced. Submit drafts of four layouts per poster to COR for review and approval. This process shall require up to three iterations. Produce a total of 50 finalized “movie style” posters. Each participating treatment facility shall be given ten posters.

CDC shall retain the remainder for future use.

Beta-Test of Draft Video

Task 15. Internal Review Board (IRB) Protocol

Develop draft and final IRB protocol, and obtain local IRB approvals or exemptions prior to observations and supplemental data collection.

Task 16. Prepare for Beta-Test

Assess and coordinate the integration of the beta-test of the draft video in participating treatment facilities (e.g., ensure that each facility designates a staff person responsible for playing the video during the course of the beta-test and a staff person to abstract the clinic’s medical record data regarding ART initiation and adherence among its patients) and provide all equipment to intervention facilities, if needed (e.g., TVs, video players). Identify location in each facility from which to conduct systematic, unobtrusive observations of the reactions of patients to the draft video intervention. Preparation shall be completed by month 14 after award.

Task 17. Beta-Test Managers

Assign one beta-test manager to each participating treatment facility during the beta-test period.

Beta-test managers shall be responsible for conducting systematic observations and receiving data abstracted from medical records, ensuring that data is stripped of personal identifying information, cleaning the local dataset, and transferring the data.

Task 18. Databases

The contractor shall not enroll individual patients into assessment activities. The beta-test shall rely on objective measures of the reactions of all patients in participating treatment facilities collected from systematically observed reactions and routine medical record data. At a minimum, the database shall include the following supplemental items that are routinely contained in patient medical records across all facilities: unique project ID number, sex, gender identity, race/ethnicity, age, sexual orientation, clinic visit dates, date of HIV diagnosis, date of ART initiation, ART regimens, CD4 counts, and viral loads. Develop shell project databases and data dictionaries/codebooks defining characteristics of the beta-test observational and supplemental assessment data.

Task 19. Pilot-Tests

Pilot-test collection of beta-test assessment data and data transfer procedures in each participating treatment facility.

Task 20. Technical Discussions

Participate in technical discussions (email and conference calls) on the refinement of the beta-test assessment plan, including finalization of a data collection instrument for the systematic observations and scheduling for collecting observational data and abstracting medical record data. The data collection instrument will be finalized by month 7 from date of award.

Task 21. Retrospective Data

Task 21.1- Data Management Manage the abstraction and cleaning of 10 months of retrospective supplemental data from the participating treatment facilities. Merge individual facility data files into one cross-facility file maintained by the contractor. Run consistency and error checks.

Task 21.2- Retrospective dataset Submit retrospective dataset electronically in SAS and SPSS to the COR. Submit data codebook in Microsoft Word.

Task 22. Beta-Test

Create a plan to monitor progress and evaluate project goals, including number of monthly patient visits and number of observation events in the participating treatment facilities. Begin beta-test of the draft video intervention in participating HIV/AIDS Treatment Facilities by 15 months from date of award and finish beta-test by 25 months from date of award. This length of time will ensure that reactions of many patients of each age group, race/ethnicity, and sex will be included in the assessment.

Task 23. Interim Datasets

Task 23.1- Data Management Manage the quarterly tabulation and cleaning of observational data and the abstraction and cleaning of 10 months of prospective supplemental data from the participating treatment facilities. Merge data from individual facilities into the cross-facility file. Run consistency and error checks.

Task 23.2- Interim datasets Submit interim datasets electronically in SAS and SPSS to the COR. Submit interim data codebooks in Microsoft Word.

Task 24. Final Datasets

The central, cross-facility database shall undergo a final cleaning to ensure that all inconsistencies and queries have been resolved before the final dataset is submitted to the COR.

Submit final beta-test dataset electronically in SAS and SPSS to the COR. Submit final data codebooks in Microsoft Word.

Finalize Video Intervention

Task 25. Refined Video

CDC will analyze the beta-test data. Analysis of the observational data will determine which vignettes and portions of vignettes elicited positive and negative viewer reactions. Analysis of supplemental medical record data will serve as a cross-check. Observed viewer reactions and influence on ART initiation and adherence should correspond. Following sub-group analyses, CDC will determine what minor refinements to the video content are needed, based upon outcome effect sizes. Use findings from CDC’s analysis of the beta-test data to refine the video-based intervention. This process shall require up to two iterations.

Task 26. User’s Guide

Develop a concise users’ guide that shall describe the video intervention, provide clinic directors with simple instructions to integrate and sustain the video, and provide clinicians with suggestions for how to reinforce key video messages in their clinical practice. Submit draft and final versions of the users’ guide to the COR for review and approval. This shall require up to 3 iterations.

Task 27. Intervention Package

Submit final intervention package that can be duplicated for dissemination to the COR. The package shall include master copies of the refined video with English open-captions (on DVD), master copies of the refined video with Spanish open-captions (on DVD), a concise users’ guide (on CD-ROM), and electronic versions of the intervention posters.

Task 28. Visits, Calls, and Meetings

Facilitate and participate in all facility visits and conference calls. Draft meeting and call agendas and discussion minutes and submit to the COR within 10 days of all meetings/calls.

Task 28.1- Travel Not to exceed one 1-day visit per facility by one person to prepare facilities for the beta-test (Task 16). Not to exceed four visits per facility by local beta-testers, who will collect observational and medical record data during each of the first three visits (Tasks 22-23) and medical record data during the fourth visit (Task 24).

V. Reporting Schedule

1) Quarterly Progress Reports: The reports shall be due quarterly for the duration of the project. They shall be due no later than the 5th of the month following the end of the quarter and shall not exceed 10 pages. The report headings shall specify the quarter and contract year of the report (e.g., Third Quarter Progress Report, Contract Year 1), the contract title and award number, and the reporting period (e.g., July - September 2014). The reports shall be organized by task and indicate task status (i.e., pending, ongoing, completed). For pending tasks, state the event which shall initiate the task and its expected date. For ongoing tasks, report on progress made, problems encountered, solutions planned or tried, and expected completion date. Tables may be used to present information on a task more concisely. The contractor shall use a consistent filename convention that includes the reporting quarter and contract year at the end of the filename. The reports shall be acceptable if they contain the information outlined above, are accurate, and are submitted on time.

2) Report on proposed format and content (Task 3): The report shall be due no later than three months from the date of award and shall not exceed 35 pages. The report shall contain three sections. The first section shall start with a list of the Technical Consultants (TC) who provided input and the methods used to collect the TC’s input. The methods shall be followed by a summary of the TC’s input on various potential formats (e.g., soap opera, support groups, use of animation) and content (e.g., issues, strategies, information) to address project objectives. This section also shall include TC input on ways to ensure that the format and content shall be culturally-relevant and engaging for HIV-positive minority persons of various ethnicities, genders, ages, and sexual orientations. The second section of the report shall contain the behavioral theory or theories and empirical framework that the contractor proposes to use to guide the intervention development process and the contractor’s rationale for their selection. The third section shall contain the contractor’s proposal for the video intervention’s format and content, including number of and topics for animation sequences;

description of how CDC’s learning objectives, issues, and strategies and TC’s input were incorporated; and how the project objectives shall be met in a video shorter than 30 minutes. The report shall state how the format and contents shall address and promote early initiation of ART among treatment-naïve HIV-positive patients, adherence to ART and retention in care among HIV-positive patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and patient-initiated discussion of these topics with their providers. The report shall be acceptable if it contains the information outlined above and is submitted on time. The COR may accept the theories, framework, format, and content proposed for the video or may require revisions. The contents of the report shall guide COR and contractor discussions and decision-making.

3) Report on potential facilities (Task 2): The report shall be due no later than six months from the date of award and shall not exceed 15 pages. The report shall contain information on a minimum of four HIV/AIDS treatment facilities, including a) AIDS prevalence in its jurisdiction; b) number of unique HIV-positive patients managed annually; c) percentage of the clinic population who are African American or Latino; d) percentage of patients who have suppressed viral load; e) whether the facility uses electronic medical records; f) number and type of clinic staff; g) design of the waiting room, including if it is shared by patients not being treated for HIV/AIDS; h) number of exam rooms; i) average amount of time patients spend in the waiting room; j) current audiovisual capabilities, including current use of waiting room videos; and f) statement that the contractor has verified that the facility is not participating in another behavioral intervention research project. The report shall be acceptable if it is submitted on time and identifies four facilities that meet project criteria and are willing to participate in beta-testing the video.

4) Draft final report: The report shall be due no later than 27 months from the date of award and shall not exceed 100 pages. The report shall begin with an executive summary of the video development process and beta-test results. The report shall contain a detailed description of the completion of each task and how preliminary analyses of the beta-test data were used to refine the video. The report shall be acceptable if it is thorough, accurate, and submitted on time.

5) Final report: The report shall be due 10 days before the end of the contract and shall not exceed 100 pages. The format and content areas of the final report shall be the same as for the draft final report.

The report shall be acceptable if it reflects all of the COR’s edits from the draft report and is submitted on time.

VI. Special Considerations

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 electronic data bases and data collection system for monitoring outcomes among HIV-positive minority patients in clinical care shall become part of CDC’s Privacy Act System of Records Notice.

http://www.whitehouse.gov/omb/Circulars_a130_a130trans4/ http://csrc.nist.gov/policies/FISMA-final.pdf http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final-errata.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final-errata.pdf http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf

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.14.4), computer-based data collection system for monitoring outcomes among HIV-positive minority patients in clinical care the assessment of the waiting room-delivered video to enhance ART readiness and adherence for HIV-positive minority persons 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 COR 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)

A revised data security plan shall be submitted to the COR no later than 6 months after contract award.

The revised data security plan shall include methods for protecting privacy and confidentiality of patients’ medical data and maintaining data security during data transfers, as agreed upon with participating treatment facilities. Certification and Accreditation process shall be completed and documentation of completion shall be submitted to the COR no later than 12 months after contract award.

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 COR, 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 COR.

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 shall 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 COR.

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 desktop’s residing location. All mobile devices, portable media and transfer data files that contain sensitive information from the data collection system shall be encrypted using FIPS 140-2 compliant algorithms.

C.A. Section 508 http://ais.nci.nih.gov/forms/Suitability-roster.xls

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors 1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW: 36 CFR 1194.24(c).

Paperwork Reduction Act Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a contract shall be subject to review and approval by the Office of Management and Budget (OMB). Due to the nature of this research project, CDC shall seek an exemption from OMB.

If the exemption is not granted, it shall be the responsibility of the COR to submit the Information Collection Request for review and approval. The review process may take more than 12 months to complete. The Contractor shall be provided copies of such documentation as needed. Should the approval process take longer than 9 months and impact the start date of the research project, the Contractor shall address the need to obtain OMB approval in the proposal’s timeline and how a delay in data collection may be managed.

VII. Government Furnished Property/Materials

The COR will provide key learning objectives, issues to address, and coping strategies to recommend in the video (Attachment A). If required, the COR will develop and provide documentation of OMB PRA approval or exemption.

VIII. References

1. Cohen MS, Chen YQ, McCauley M, et al. (2011). Prevention of HIV-1 infection with early antiretroviral therapy. NEJM, 365(6):493-505.

2. Thompson MA, Aberg JA, Cahn P, et al. (2010). Antiretroviral Treatment of Adult HIV Infection – 2010

Recommendations of the International AIDS Society – USA Panel. JAMA, 304(3):321-333.

3. Ray M, Logan R, Sterne JA, et al. (2010). The effect of combined antiretroviral therapy on the overall mortality of HIV-infected individuals. AIDS, 24:123-37.

4. Palella FJ, Chmiel JS, Moorman AC, Holmberg SD. (2002). Durability and predictors of success of highly active antiretroviral therapy for ambulatory HIV-infected patients. AIDS, 16, 1617–1626.

5. Hall HI, Frazier EL, Rhodes P, et al. Continuum of HIV care: Differences in care and treatment by sex and race/ethnicity in the United States. Abstract FRLBX05, 2012. XIX International AIDS Conference, Washington, DC. 2012.

6. CDC. Vital Signs: HIV Prevention Through Care and Treatment – United States. MMWR 2011 (Early

Release);60:1-6.

7. CDC. Compendium of Evidence-Based HIV Behavioral Interventions: Medication Adherence Chapter.

http://www.cdc.gov/hiv/topics/research/prs/ma-chapter.htm. Accessed January 10, 2013.

8. CDC. High-Impact HIV Prevention, CDC’s Approach to Reducing HIV Infections in the United States.

www.cdc.gov/HIV. August 2011.

9. Warner L, Klausner JD, Rietmeijer CA, et al. (2008). Effect of a Brief Video Intervention on Incident

Infection among patients Attending Sexually Transmitted Disease Clinics. PLoS Medicine, 5(6)919- 927.

http://www.cdc.gov/HIV

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

E.1 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acqnet.gov http://farsite.hill.af.mil/

(End of Clause)

FAR SOURCE TITLE AND DATE

52.246-4 Inspection of Services – Fixed Price (Aug 1996)

E.2 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation…