Attachment_3_-_Task_Order__0001_Understanding_Barriers_and_Facilitators_Experience_By_HIV_Care_Providers.pdf

Solicitation #2013-N-15633 Attachment 3

Task Order 0002 (To be priced by Offerors)

TASK ORDER 0002 Statement of Work for Solicitation # 2013-N-15633

Title of Project: Understanding Barriers and Facilitators Experience By HIV Care Providers

I. Background:

Advances in antiretroviral treatment (ART) have made it possible for persons living with HIV to have longer, healthier, and productive lives. A consistently suppressed HIV viral load resulting from ART can reduce morbidity and mortality, and lower the probability of transmitting HIV to an uninfected sex partner . HIV testing is the entry point to the HIV care and treatment continuum that includes diagnosis through testing, linkage to and retention in continuous HIV medical care, and appropriately timed ART to achieve viral suppression

According to recently released data by the CDC, of the estimated 1.15 million persons living with HIV in the United States in 2009, 82% were diagnosed through HIV testing. However, only 66% of HIV-positive persons were successfully linked to HIV care within 3 months of diagnosis, 37% received at least one medical care visit, 33% were prescribed ART, and 25% had a suppressed viral load (≤ 200 copies/mL) due to regular medical care and medication adherence

HIV care providers play a critical role in improving health outcomes of HIV-positive patients. To date, there are no concrete recommendations for how to best monitor or support HIV care and ART adherence.

Factors that contribute to the care and treatment of HIV positive persons include systematic monitoring of the patient at all stages of the care continuum fully supported by the integration of data systems and resources. In addition, understanding how providers manage comorbid conditions, such as HIV and diabetes, may also play an important role in HIV treatment adherence . Provider communication also impacts patient adherence and is an important component of engaging patients in care and treatment

Identifying and understanding the issues barriers and facilitators experienced by HIV care providers is a critical component to the success of HIV prevention, care, and treatment.

To successfully engage people in care and maintain adherence to HIV treatment we must understand how

HIV care providers and the issues they experience impact HIV treatment. Understanding the contextual factors underlying these issues can identify new opportunities for intervention, and improve prevention, care and treatment outcomes. The purpose of this project is to (1) conduct qualitative inquiry methods to help answer timely questions related to HIV prevention, care and treatment, and (2) to use the findings to strengthen existing and future HIV prevention, care, and treatment efforts.

Cohen, M.S., et al., Prevention of HIV-1 Infection with Early Antiretroviral Therapy. New England Journal of Medicine, 2011. 365(6): p. 493-

505.

Cohen, M.S., et al., Prevention of HIV-1 Infection with Early Antiretroviral Therapy. New England Journal of Medicine, 2011. 365(6): p. 493-

505. Gardner, L.I., et al, Efficacy of a Brief Case Management Intervention to Link Recently Diagnosed HIV-infected Persons to Care. AIDS

2005; 19:423-31.

Hall, H.I., et al., Continuum of Care: Differences in Care and Treatment by sex and race/ethnicity in the United States [abstract # FRLBX05].

Presented at AIDS 2012, Washington D.C.

Thompson, M, et al., Guidelines for Improving Entry Into and Retention in Care and Antiretroviral Adherence for Persons With HIV:

Evidence-Based Recommendations From an International Association of Physicians in AIDS Care Panel. Ann Intern Med. 2012;156:817-833.

Beach, M. C., Keruly, J. and Moore, R. D. (2006), Is the Quality of the Patient-Provider Relationship Associated with Better Adherence and

Health Outcomes for Patients with HIV?. Journal of General Internal Medicine, 21: 661–665. doi: 10.1111/j.1525-1497.2006.00399.x

This project aligns with NHAS Goal 2 [Increasing Access to Care and Improving Health Outcomes for

People Living with HIV] by collecting qualitative data to support the following recommended step: the establishment of a seamless system to immediately link people to continuous and coordinated care when they are diagnosed with HIV (Step 1), and support people living with HIV with co-occurring health conditions and those who have challenges meeting their basic needs (Step 3). The project is also consistent with NHAS Goal 3 [Reducing HIV-related Disparities and Health Inequities] and supports the following recommend steps: reduce HIV-related mortality in communities at high risk for HIV infection

(Step 1), and adopt community-level approaches to reduce HIV infection in high-risk communities (Step

2).

II. Purpose:

The purpose of this task order is to conduct qualitative research with primary care doctors and healthcare professionals to understand the issues experienced providing HIV screening, care, and treatment to populations at greatest risk for HIV, including men who have sex with men (MSM), young persons, and racially and ethnic minorities.

III. Scope of Work:

Independently, and not as an agent of the government, the Contractor shall furnish all the necessary personnel, facilities, supplies, and equipment required to conduct qualitative research with primary care doctors and healthcare providers delivering HIV testing, screening, care, and treatment. All instruments developed, all data collected, and analysis and findings shall become the property of the Government. The requirements of this task order fall under the following Task Areas of the basic contract: small-scale qualitative research.

IV. Technical Requirements:

For each task, the contractor shall have ongoing meetings with the Contracting Officer Representative

(COR) and designated site staff. Meetings may include face to face, web conference calls, web-based presentations, or teleconferences. The Contractor should expect to conduct one (1), one-day, face to face, kick-off meeting at CDC offices in Atlanta. All documents sent to COR for review shall be returned with comments within 10 business days of receipt.

The Contractor shall perform the following tasks:

Task 1: Participate in a kick-off meeting with the Contracting Officer Representative (COR) and DHAP staff to discuss the tasks outlined in the statement of work. The Contractor shall plan for a one day meeting to be held in Atlanta, GA. The contractor shall submit a synopsis of the kick-off meeting to the

COR within 3 days of the meeting.

Task 2: Design data collection tools and instruments, including but not limited to, demographic questionnaires, in-depth interviews, and focus group guides. Data collection instruments should include, but are not limited to, questions on the following topics: barriers and facilitators to providing culturally competent care, provider HIV prevention information needs, use of electronic media, patient resources used and needed, use of continuing medical education (CME) courses, communication barriers experienced, strategies to improve patient adherence, communicating about the effects of HIV treatment.

All questions must be agreed upon with the COR.

Task 2.1: The draft instruments shall be submitted to the COR for review and approval.

Task 2.2: The finalized instruments shall be submitted to the COR and included in the study protocol, IRB submission, and OMB request.

Task 3: Create a sampling plan that includes recruiting and enrolling 30 HIV clinicians, primary care doctors, and healthcare professionals in public and private clinics, hospitals, and other HIV/AIDS service providers. The sample should be racially and ethnically diverse or serve populations with racial and ethnic diversity. The plan should describe the approach for recruiting and enrolling participants, including use of social media, the Internet, print marketing materials, and other methods to find and enroll participants.

The sampling plan should identify the sampling frame and approach and all procedures for recruitment and enrollment, and include all strengths and limitations.

Task 3.1: The sampling plan should be submitted to the COR for review and approval.

Task 3.2: The finalized sampling plan shall be submitted to the COR and included in the study protocol for IRB submission, and in the OMB request.

Task 4: Create a data plan that describes all data collection, management, handling, and analysis procedures. Include staff experience and training, procedures for administering interviews and conducting/facilitating focus groups, and plans for conducting other qualitative methods, such as direct observation. The plan should also include a description of how participant confidentiality and privacy shall be protected, the development of a rigorous codebook, inter- and intra-coder reliability procedures, use of software for managing and analyzing qualitative data, and the development of data models, matrices, and coding frequencies. The Contractor shall describe a plan for preparing and submitting a final dataset to the COR.

Task 4.1: The draft data plan should be submitted to the COR for review and approval.

Task 4.2: The finalized data plan shall be submitted to the COR and included in the study protocol, IRB submission, and OMB request.

Task 5: Create a study protocol that describes the research problem(s) with a literature review and the study procedures. The protocol shall include the sampling plan, data plan, and study instruments. The study protocol shall also describe study staff roles and responsibilities, human subjects’ protections, and security protocols.

Task 5.1: The study protocol should be submitted to the COR for review and approval.

Task 5.2: The finalized study protocol shall be submitted to the COR, local and federal IRB submissions, and OMB request.

Task 6: Obtain IRB and OMB approvals. The Contractor shall create all IRB and OMB approval packages, including all previously approved study protocols, sampling plans, and data collection instruments.

Task 6.1: The finalized IRB protocol shall be submitted to the COR local and federal IRBs as required.

Task 6.2: The finalized OMB information request shall be submitted to the COR for CDC and

HHS clearance.

Task 7: Conduct procedures for collecting, handling, and analyzing qualitative data as outlined in the IRB and OMB approved protocols.

Task 8: Submit a final dataset to CDC that includes an electronic copy of all interview transcripts, figures, models, codebooks, coding frequencies, and any other documentation that supports the qualitative findings.

V. Reporting Requirements:

The contractor shall provide the following reports to the COR:

(a) Monthly Reports:

A monthly progress report that contains at a minimum, the following information: a brief description of requirements, accomplishments during the reporting period and significant events regarding the task order, deliverables submitted, progress on deliverable products, any current and anticipated problems and solutions proposed stakeholder participation and issues, communications with persons, groups, organizations, and agencies and the nature of those communications, activities scheduled for the next month, and key personnel changes and a brief summary of activity planned for the next reporting period.

(b) Conference Calls

The Contractor shall have at least 2 conference calls per month with the COR to discuss progress, problems and solutions. Data shall be presented electronically via web based presentations or teleconference as determined by the COR.

(c) Final Project Report

The Contractor shall submit a draft report to the COR 2 weeks before the end of the project summarizing the project and its findings in narrative and figurative format. The Contracting Officer Representative shall respond with comments on the draft final report within ten (10) working days of its receipt.

VI. Deliverables:

The contractor shall furnish the COR the following items in the quantities and during the time periods indicated. All documents to be in Microsoft Word or other format, as specified by CDC.

Task/Subtask Deliverable Format of Deliverable Due Date

Task 1 Synopsis of kick-off meeting

1 electronic copy Within 3 days of meeting.

Task 2.1 Draft data collection instruments

1 electronic copy Within 1 month of award of contract.

Task 2.2 Final data collection instruments

1 electronic copy Within 2 weeks of receipt of CDC comments

Task 3.1 Draft Sampling Plan 1 electronic copy. Within 1 month of award of contract.

Task 3.2 Final Sampling Plan 1 electronic copy Within 2 weeks of receipt of CDC comments

Task 4.1 Draft data plan 1 electronic copy. Within 1 month of award of contract.

Task 4.2 Final data plan 1 electronic copy Within 2 weeks of receipt of CDC comments

Task 5.1 Draft study protocol 1 electronic copy Within 6 weeks of award of contract.

Task 5.2 Final study protocol 1 electronic copy Within 1 week of receipt of CDC comments

Task 6.1 IRB submission 1 electronic copy. Within 7 weeks of award of contract

Task 6.2 OMB submission 1 electronic copy Within 7 weeks of the plan approved by CDC.

Task 7 Implement study protocol

Weekly updates on progress via conference calls with COR

For one month after receipt of all IRB and

OMB approvals

Task 8 Submit final dataset and supporting documents to

CDC

1 electronic copy 2 weeks before the end of the task order.

Reporting Requirements

(a)

Monthly Progress

Report

1 electronic copy 15 th of each month.

Reporting Requirements

(c)

Final Project Report 1 electronic copy 2 weeks before the end of the task order.

C8(a) of the Basic

Contract

Final QCP 1 electronic copy Within 15 days of task order arward

VII. Special Considerations

During or after the life of this task order, the contractor shall not release any data, publications or materials developed under this task order without prior CDC clearance and approval. CDC retains the rights to all data developed under this task order.

Security Compliance

This Request for Task Order Proposal requires the successful offeror to have the ability to host and maintain a system for data collection, management, use, and reporting to support activities funded by the federal government. IMPORTANT NOTE TO OFFERORS: The following information shall be addressed in a separate section of the Technical Proposal entitled, “Information Security.” Information

Security is applicable to this solicitation because 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. We provide the following information to assist in the preparation of proposals in order to assure that the existing data system, which would be licensed for use by CDC grantees and CDC employees, meets the security standards described below.

First, The EGovernment Act of 2002, (Federal Information Management Act) and the below federal policies dictate the framework for assuring information security for data systems operated by or on behalf of the Federal government. These are summarized below.

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, 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, offeror (including sub-offeror), 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.

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)

Second, the Offeror should demonstrate understanding of security requirements by attaching a Draft Data

System Security Plan or information system security plan (SSP). The SSP should be a brief and general narrative description of the system and its integration with the CDC Network Infrastructure.

The initial draft and all subsequent versions of the SSP must be prepared and submitted by the Offeror to the CDC contracting officer and to the CDC Contracting Officer Representative, in Microsoft Word compatible format. The successful Offeror shall be responsible for ensuring that the security plan is acceptable to the CDC Contracting Officer Representative and the CDC Information System Security

Officer as well as any subsequent federal reviewers (e.g., Center and/or HHS officials, OMB officials, etc.). Comments shall be conveyed to the Offeror by the Contracting Officer Representative and/or the contracting officer.

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

Once an award is made, the Contracting Officer Representative and the contracting officer will review the draft SSP and any subsequent versions and submit recommendations/comments to the Offeror within 14 working days after receipt. The Offeror shall incorporate the Contracting Officer Representative’s recommendations and submit paper and electronic copies of the security plan to the contracting officer and to the Contracting Officer Representative within five working days after receipt of the Contracting

Officer Representative's comments. The resultant contract will require the draft SSP to be finalized in coordination with the Contracting Officer Representative no later than 90 calendar days after contract award. Also, the successful Offeror, in conjunction with the CDC Center ISSO, is required to update and resubmit its SSP to CDC every three years following award or when a modification has been made to its internal system. In addition to developing and maintaining an SSP, the successful Offer or shall be responsible for continuously assessing and assuring information security for the project and for updating the security plan as needed throughout the duration of the agreement.

The SSP is part of the Certification and Accreditation (C&A) process required by the EGovernment Act of 2002 and NIST Special Publication 800-37 and will include selected mandatory controls required by

NIST Special Publication 800-53, Volume I & II. The offeror in conjunction with the Center

Information System Security Officer (ISSO) will submit C&A documentation to the CDC Chief

Information System Officer (CISO). The successful completion of the C&A documents will result in an award of an Authority To Operate. Based on guidance in FIPS 199 and NIST SP 800-60 (information type D.14.2), the system will be assigned an overall security category (SC) of MODERATE based on

(confidentiality, MODERATE), (integrity, MODERATE), and (availability, LOW) impact levels. Therefore, details contained in the Offeror’s draft SSP shall include NIST SP 800-53 security control baselines for moderate impact systems.

The Offeror shall allocate staff, and specify a budget line item, for maintaining computer and data security on the licensing contract and for maintaining the SSP. In conjunction with the CDC Center ISSO the Offeror will help complete the necessary additional documents to obtain a CDC Certification and

Accreditation. Those documents included are listed below. Normally, these documents will be completed by the CDC Center ISSO/Security Steward with information provided by the Offeror. Templates of the documents will be provided to the offeror 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)

Third, the Offeror shall respond to the following seven security–associated requirements in the application:

(1) Position Sensitivity Designations

The following position sensitivity designations and associated clearance and investigation requirements apply under this licensing contract:

Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC, MBI or LBI).

Licensor 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 Licensor will be required to submit a roster of all staff (including sub-offeror staff) working under the contract that will have the ability to access HIV prevention program information from the system. 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 licensor of the appropriate level of suitability investigations to be performed, but Licensor employees and subcontractors who have met investigative requirements within the last five years may only require an updated or upgraded investigation. An electronic template, “Roster of Employees Requiring

Suitability Investigations,” is available for offeror use at: http://ais.nci.nih.gov/forms/Suitability-roster.xls. Upon receipt of the Government’s notification of applicable suitability investigations required, the Licensor shall complete and submit the required forms within 30 days of the notification.

Non-Disclosure Agreements

The Offeror and any sub-Offerors or employees are forbidden from sharing any technical or logistical information they may gain in conjunction with matters related to this task order that could jeopardize the physical or information security of CDC or its employees, projects, or information systems.

The following apply to Licensor employees and their subcontractors associated with the 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 will not have access to sensitive project data.

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

Note that CDC is not required to grant the successful Offeror access to CDC information technology resources (e.g., computers, network, email, etc.). If CDC were to agree to grant the Offeror, or any of its employees, access to CDC information technology resources at any point in time, it would be the

Offeror's responsibility to ensure that all of its employees to be granted such access complete any additional required information security courses that CDC specifies prior to gaining or utilizing such access.

It is the Offeror's responsibility to ensure that all employees have met CDC and federal requirements, such as, for example, completion of background checks, before gaining or utilizing access to CDC information technology resources.

(2) Privacy Compliance

Licensor shall abide by all requirements of the Privacy Act of 1974. Pursuant to those requirements, CDC-funded HIV prevention program data files will become part of CDC’s HIV prevention program records covered under OMB ICR number 0920-0696.

Licensor in conjunction with CDC Center ISSO shall conduct and maintain an i 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 CDC Center ISSO and offeror, to determine if a major change to the system has occurred, and if a PIA update is needed.

(3) Offeror’s Official Responsible for Information Security

The offeror shall include in the “Information Security” part of the 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.

(4) Rules of Behavior

The offeror’s employees and subcontractors shall comply with the HHS Information Technology General

Rules of Behavior.

http://ais.nci.nih.gov/forms/Suitability-roster.xls http://ais.nci.nih.gov/forms/Suitability-roster.xls

(5) 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 employee, including subcontractors, 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. This would be provided at the

Offeror's expense and would be the Offeror's responsibility to plan and arrange.

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

(6) Encryption

All sensitive CDC-funded data 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 (including e-mail attachments) that contain sensitive CDC- data shall be encrypted using FIPS 140-2 compliant algorithms.

IX. Government Furnished Equipment:

All documents and background materials needed to accomplish the required tasks shall be provided by the Government at the kick-off meeting and subsequent meetings between the Contractor and the

Government.

X. Period of Performance:

Twelve months from date of task order award.

XI. Place of Performance

The Contractor’s Facility.

XII. Price Schedule

The following Price schedule shall be completed and included within the Business Proposal for theTask Order.

CLIN Supplies/Services Qty/Unit Unit Price Extended Price

0001 Contractor shall support services for Understanding

Barriers and Facilitators

Experience By HIV Care

Providers in accordance with the attached Statement of

Work

1 Job

Period of Performance: 12 months from the date of award