Morbidity and Risk Behavior Surveillance

Announcement Type: New.

Funding Opportunity Number: 04155.

Catalog of Federal Domestic Assistance Number: 93.944.

Key Dates:

Application Deadline: July 26, 2004.

Executive Summary: HIV/AIDS surveillance programs function in all U.S. states to collect a core set of information on the characteristics of persons diagnosed with, living with, and dying from HIV infection and AIDS. Supplemental surveillance projects have historically provided complementary information about clinical outcomes of HIV infection, and behaviors of persons with HIV infection with respect to care seeking and utilization of care (which affect prevention of HIV-related morbidity) and ongoing risk behaviors (which affect further transmission of HIV).

Supplemental surveillance projects initiated in the 1990s were funded at a time when the HIV epidemic was substantially more concentrated in large cities, especially in the East and the West. Currently, a much larger number of cities and states are heavily impacted by the HIV epidemic. Supplemental surveillance data are thus needed on a national basis (e.g., beyond the currently funded supplemental surveillance sites) to understand the provision and impact of treatments for HIV, health care utilization, ongoing HIV risk behaviors, care seeking behaviors, quality of life for persons with HIV infection, and acceptance of and adherence to prescribed antiretroviral therapy. These data will be especially important as a means of evaluation for new prevention initiatives (e.g., Advancing HIV Prevention) which call for a focus on provision of prevention services to persons living with HIV infection.

There is also a need for high-quality, population-based data on quality of care and severity of need for care, prevention, and support services on the local level to assist local planning groups (i.e. Community Planning Groups and local planning councils) in determining local allocation of CDC and Ryan White CARE Act funds.

In order to implement a supplemental surveillance system which will address these data needs, CDC has developed a study design which will rely on a national probability sample of persons with HIV infection to generate nationally representative estimates of clinical outcomes and HIV-related behaviors. The methodology has been demonstrated as appropriate for this purpose by the Health Care Services and Utilization Survey, conducted in the mid-1990s by the RAND Corporation. CDC has contracted with the RAND Corporation to draw a nationally representative sample of states using probability proportional to size methods. Based on availability of resources, 20 states were selected by RAND. Cities separately funded for HIV surveillance were deemed eligible for funding if their state was selected for funding. This resulted in 26 sites (20 states and 6 cities) being eligible for funding.

In the 20 selected states, HIV care providers will be randomly selected to participate in the study. For patients randomly selected from these providers, data on HIV care will be abstracted from medical records, and the patients will be offered participation in an interview. CDC has piloted these methods for population-based patient selection since 1998 in 12 sites in the Survey of HIV Disease and Care (SHDC) project.

I. Funding Opportunity Description

Authority: This program is authorized under the Public Health Service Act Sections 301 (42 U.S.C. 241); 318B (42 U.S.C. 247c-2), as amended.

Purpose: The purpose of the program is to develop a supplemental HIV/AIDS surveillance system which will produce population-based estimates of characteristics of persons with HIV infection and the care they receive. By using probability sampling, estimates developed will be rigorously representative of the underlying populations diagnosed with and in care for HIV infection in the United States and in the participating project sites.

Measurable outcomes of the program will be in alignment with the following goal for the National Center for HIV, STD and TB Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs.

Activities: Awardee activities for this program are as follows:

Year 1 Activities (September 2004-May 2005—9 Months)

For sampled sites that have successfully conducted Supplement to HIV/AIDS Surveillance (SHAS) and either Adult Spectrum of Disease (ASD) or Survey of HIV Disease in Care (SHDC) in the past; or that are currently conducting Survey of HIV Disease in Care-Plus (SHDC+) (successful completion is defined as having transmitted abstraction or interview data to CDC as of May 17, 2004) (see eligibility criteria):

• Soon after receipt of funds, attend a principal investigators meeting at CDC to review and finalize the project protocol and data collection instruments.
• Assist in the development and review of the required protocols and data collection instruments.
• Work with providers of HIV/AIDS care to educate them about the surveillance project, determine potential barriers to provider participation, and work to improve the likelihood of provider and patient participation in this activity.
• Work with CDC to develop a database and database management capability for this project.
• Develop a de-duplicated list of HIV/AIDS care providers in the jurisdiction using data from the HIV/AIDS Reporting System (HARS).
• Provide the list of providers (by unique identifier or non-identifying code determined by CDC), to CDC and to a CDC contractor for development of a sample of providers.
• Approach selected providers to solicit the providers' participation in the project. Work with selected providers to secure human subjects review (if required).
• Participate in required training activities: send appropriate staff members to interviewer, abstractor, and data manager training meetings before beginning data collection.
• Abstract the medical records of sampled patients for variables related to clinical care and outcomes as determined in collaboration with CDC.
• Work with sampled HIV/AIDS care providers to contact sampled HIV-infected persons to conduct personal interviews. During the interview, patients will be asked about care seeking and ongoing risk behaviors as well as multiple sources of care during the surveillance period. Consent for release of medical records will be obtained if possible, and every effort will be made to contact all providers of care named for each sampled participant during the surveillance period and review and abstract medical records at those sites.
• Maintain an electronic database of information linked to interview and chart review data; periodically transmit this data to CDC with patient unique identifier. No individual patient names will be transmitted to CDC or to the CDC contractor.
• Data security: Protect data in accordance with “Appendix C” of CDC's “Guidelines for HIV/AIDS Surveillance.” Applicant must ensure that the program requirements detailed in the Security Standards are attained.
• Participate in periodic conference calls and grantee meetings with other funded sites and the CDC.
• Disseminate findings jointly with CDC and other participating sites.

Sampled sites that have successfully conducted either Adult Spectrum of Disease (ASD) or Survey of HIV Disease in Care (SHDC), but that have not conducted Supplement to HIV/AIDS Surveillance (SHAS) (see eligibility criteria) will conduct all startup activities listed above except the patient interview.

Sampled sites that have successfully conducted Supplement to HIV/AIDS Surveillance (SHAS), but that have not conducted Survey of HIV Disease in Care (SHDC) or Adult Spectrum of Disease (ASD) in the past (see eligibility criteria) will conduct all startup activities listed above in year 1 except the abstraction of medical records.

Sampled sites that have not conducted Adult/Adolescent Spectrum of HIV Disease (ASD), or Supplement to HIV/AIDS Surveillance (SHAS), or successfully conducted Survey of HIV Disease in Care (SHDC), will conduct all startup activities listed above in year 1 except data collection, participation in interviewer training, and participation in abstractor training.

Year 2 Activities (June 2005-May 2006)

All funded sites will conduct medical record abstractions and interviews during calendar year 2006 for care occurring during calendar year 2005.

• Participate in required training activities: send appropriate staff members to interviewer, abstractor, and data manager training meetings.
• Continue to abstract medical records and interview patients selected in year 1.
• In preparation for data collection in year 3, sites will develop a new de-duplicated list of HIV/AIDS care providers in the jurisdiction, using data from the HIV/AIDS Reporting System (HARS).
• Provide the list of providers (by unique identifier or non-identifying code determined by CDC) to CDC and to a CDC contractor for development of a sample of providers.
• Approach selected providers to solicit participation in the project. Work with selected providers to secure human subjects review (if required).
• Abstract the medical records of sampled patients for variables related to clinical care and outcomes as determined in collaboration with CDC.
• Work with sampled HIV/AIDS care providers to contact sampled HIV-infected persons to conduct personal interviews. During the interview, patients will be asked about care seeking and ongoing risk behaviors as well as multiple sources of care during the surveillance period. Consent for release of medical records will be obtained if possible, and every effort will be made to contact all providers of care named for each sampled participant during the surveillance period and review and abstract medical records at those sites.
• Maintain a database of linked interview and chart review data; periodically transmit this data to CDC with patient unique identifier. No individual patient names will be transmitted to CDC or to the CDC contractor.
• Data security: Protect data in accordance with “Appendix C” of CDC's “Guidelines for HIV/AIDS Surveillance.” Applicant must ensure that the program requirements detailed in the Security Standards are attained.
• Participate in periodic conference calls and grantee meetings with other funded sites and the CDC.
• Disseminate findings jointly with CDC and other participating sites.

Year 3 Activities (June 2006-May 2007)

• Repeat cycle of chart abstractions and interviews for persons in care for HIV infection.

Year 4 (June 2007-May 2008)

• Repeat cycle of chart abstractions and interviews for persons in care for HIV infection.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities for this program are as follows:

• Assist in the development and review of the core components of protocols.
• Participate in joint conference calls, grantee meetings, and site visits.
• Jointly disseminate findings.
• Collaborate with the CDC-funded contractor to develop a sample of HIV/AIDS care providers from the list of providers developed by the grantee.
• Collaborate with the CDC-funded contractor to develop a sample of HIV-infected persons from the list of patients developed by the sampled providers.
• Provide training and technical support for data abstractors and interviewers, including technical support for electronic data collection and data transfer to CDC.
• Provide training and technical support for data management and data analysis.

II. Award Information

Type of Award: Cooperative Agreement.

CDC involvement in this program is listed in the Activities Section above.

Fiscal Year Funds: 2004, 2005, 2006, 2007.

Approximate Total Funding: $41,000,000.

Approximate Number of Awards: 26 awards.

Approximate Average Award:

Year 1 (September 2004-May 2005, 9 Months)

Sampled sites that have successfully conducted Supplement to HIV/AIDS Surveillance (SHAS) and either Adult Spectrum of Disease (ASD), Survey of HIV Disease in Care (SHDC) in the past; or that are currently conducting Survey of HIV Disease in Care-Plus (SHDC+) will receive approximately $375,000 each in year 1.

Sampled sites that have successfully conducted either Adult Spectrum of Disease (ASD), Survey of HIV Disease in Care (SHDC) but that have not conducted Supplement to HIV/AIDS Surveillance (SHAS) will receive approximately $200,000 each in year 1.

Sampled sites that have successfully conducted Supplement to HIV/AIDS Surveillance (SHAS), but that have not conducted Survey of HIV Disease in Care (SHDC) or Adult Spectrum of Disease (ASD) in the past will receive approximately $270,000 each in year 1.

Sampled sites that have not conducted Adult/Adolescent Spectrum of HIV Disease (ASD), or Supplement to HIV/AIDS Surveillance (SHAS), or successfully conducted Survey of HIV Disease in Care (SHDC) will receive approximately $140,000 each in year 1.

Years 2, 3 and 4

For all grantees, budgets for collecting chart abstraction data and interviews for persons in care for HIV infection will be approximately equal for years 2, 3 and 4. Average budgets will be as follows, based on the number of matched medical record abstractions/interviews allocated by random sampling:

• 1000 abstractions/interviews: $900,000-$1,100,000
• 800 abstractions/interviews: $700,000-$900,000
• 500 abstractions/interviews: $500,000-$700,000
• 400 abstractions/interviews: $450,000-$550,000
• Less than or equal to 200 abstractions/interviews: $150,000-$300,000

All eligible applicants that are technically acceptable will be funded. Funding levels will be determined based on number of abstractions and interviews to be performed, and site-specific variations in cost. For the number of records to be collected, see Appendix I, as posted on the CDC Web site.

Floor of Award Range: $100,000.

Ceiling of Award Range: $1,100,000.

Anticipated Award Date: September 1, 2004.

Budget Period Length: Year 1: 9 months; Year 2-4: 12 months.

Project Period Length: 3 years, 9 months.

Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government. If full funding is not available, number of matched medical record abstractions/interviews allocated by random sampling may be reduced.

III. Eligibility Information

Eligible Applicants

Eligible applicants are limited to those jurisdictions randomly sampled by the RAND Corporation in a national probability sample. Following are the jurisdictions sampled: California; Chicago, IL; Delaware; Florida; Georgia; Houston, TX; Illinois; Indiana; Los Angeles, CA; Maryland; Massachusetts; Michigan; Mississippi; New Jersey; New York; New York City, NY; North Carolina; Oregon; Pennsylvania; Philadelphia, PA; Puerto Rico; San Francisco, CA; South Carolina; Texas; Virginia; and Washington.

Sampled sites that have successfully conducted Supplement to HIV/AIDS Surveillance (SHAS) and either Adult Spectrum of Disease (ASD) or Survey of HIV Disease in Care (SHDC), or are currently conducting Survey of HIV Disease in Care-Plus (SHDC+) are: Georgia; Houston, TX; Los Angeles, CA; Michigan; New Jersey; and Washington.

Sampled sites that have successfully conducted either Adult Spectrum of Disease (ASD) or Survey of HIV Disease in Care (SHDC) but that have not conducted Supplement to HIV/AIDS Surveillance (SHAS) are: New York City, NY and Puerto Rico.

Sampled sites that have successfully conducted Supplement to HIV/AIDS Surveillance (SHAS), but that have not conducted Survey of HIV Disease in Care (SHDC) or Adult Spectrum of Disease (ASD) are: Delaware; Florida; Illinois; Maryland; Philadelphia, PA; South Carolina; and Texas.

Sampled sites that have not conducted Adult/Adolescent Spectrum of HIV Disease (ASD), or Supplement to HIV/AIDS Surveillance (SHAS), or successfully conducted Survey of HIV Disease in Care (SHDC) are: California; Chicago, IL; Indiana; Massachusetts; Mississippi; North Carolina; New York State; Oregon; Pennsylvania; San Francisco, CA; and Virginia.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

CDC will accept and review applications with budgets greater than the ceiling of the award range.

If your application is incomplete or non-responsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use application form PHS 5161. Application forms and instructions are available on the CDC Web site, at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Submission

Application: You must submit a project narrative with your application forms. The narrative must be submitted in the following format:

• Maximum number of pages: 25. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.
• Font size: 12 point unreduced.
• Double spaced.
• Paper size: 8.5 by 11 inches.
• Paper margin size: One inch.
• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.

Your narrative plan should address activities to be conducted over the entire project period, and must include the following items in the order listed: Plan, Methods, Objectives, Timeline, Staff, Understanding, Need, Performance Measures, Budget and Justification. The budget justification will not be counted in the stated page limit.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit.

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711.

For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.

Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

Application Deadline Date: July 26, 2004.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. If you send your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If CDC receives your application after closing due to: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, CDC will consider the application as having been received by the deadline.

This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.

CDC will not notify you upon receipt of your application. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the application deadline. This will allow time for applications to be processed and logged.

IV.4. Intergovernmental Review of Applications

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state's process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html .

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing your budget, are as follows:

• None

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

Awards will not allow reimbursement of pre-award costs.

IV.6. Other Submission Requirements

Application Submission Address: Submit the original and two hard copies of your application by mail or express delivery service to: Technical Information Management—PA#04155, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

You are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement.

Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

Note:

All technically acceptable applications will be awarded appropriate funds. Your application will be evaluated against the following criteria:

1. Methods (40 points): The extent to which the proposed methods are feasible, will accomplish program goals, addresses the required follow-up activities and methods in a timely manner. Specific methods for accomplishing the following technical activities should be described.

2. Capacity (30 points): The extent to which the applicant has the appropriate facilities and staff to conduct this research; the extent to which the primary investigator is well qualified, by education and experience, to lead the project team, hire and train appropriate staff, and provide scientific oversight; the extent to which job descriptions and curricula vitae for both the proposed and current staff indicate the ability to carry out the purposes of the program.

3. Objectives (20 points): The extent to which the objectives are reasonable, time-phased and measurable. The extent to which the applicant provides reasonable methods to evaluate their progress toward the timely accomplishment of objectives.

4. Proposed data uses (10 points): The extent to which data have, or will, assist in HIV prevention and care activities, so that these data are used in formulating strategies and targeting resources for improving quality of care for HIV infection and, if applicable, getting HIV infected persons into care in a timely manner.

5. Budget (not scored): The extent to which the budget is reasonable, clearly itemized and justified, and consistent with the intended use of funds.

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by the NCHSTP. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.

V.3. Anticipated Announcement and Award Dates

September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html .

The following additional requirements apply to this project:

• AR-1 Human Subjects Requirements
• AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
• AR-4 HIV/AIDS Confidentiality Provisions
• AR-5 HIV Program Review Panel Requirements
• AR-6 Patient Care
• AR-7 Executive Order 12372
• AR-8 Public Health System Reporting Requirements
• AR-9 Paperwork Reduction Act Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-14 Accounting System Requirements
• AR-15 Proof of Non-Profit Status
• AR-21 Small, Minority, and Women-Owned Business
• AR-22 Research Integrity
• AR-23 States and Faith-Based Organizations
• AR-24 Health Insurance Portability and Accountability Act Requirements
• AR-25 Release and Sharing of Data

Additional information on these requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm .

VI.3. Reporting Requirements

You must provide CDC with an original, plus two hard copies of the following reports:

1. Interim progress report, (use form PHS 2590, OMB Number 0925-0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days before the end of the first 12 month budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives

b. Current Budget Period Financial Progress

c. New Budget Period Program Proposed Activity Objectives

d. Budget

e. Additional Requested Information

f. Measures of Effectiveness

2. Financial status report no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be mailed to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

For general questions about this announcement, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.

For program technical assistance, contact: Patrick Sullivan, DVM, PhD, Extramural Project Officer, 1600 Clifton Road, MS E-46, Atlanta, Georgia 30333, Telephone: 404-639-2090, E-mail: msw6@CDC.GOV.

For financial, grants management, or budget assistance, contact: Ann Cole, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2731, E-mail: zlr5@cdc.gov.