Linkage to HIV Care Demonstration Project

Announcement Type: New.

Funding Opportunity Number: 04154.

Catalog of Federal Domestic Assistance Number: 93.941.

Key Dates:

Letter of Intent Deadline: June 18, 2004.

Application Deadline: July 23, 2004.

Executive Summary: Data from several studies indicate that 30 to 40 percent of persons with new HIV diagnoses are not linked to an HIV care provider within 12 months of their HIV diagnosis. However, such early, prompt linkage to care is important for the health of the infected person, as well as putatively that person's potential to infect others. A recently completed Antiretroviral Treatment Access Study(“ARTAS”) in four United States (US) cities indicates that providing case managers to help such newly diagnosed persons into care significantly increases the percentage of persons who see an HIV care provider once within six months and twice within twelve months after their initial HIV diagnoses. Such case management was also cost-effective (about one thousand dollars per additional person successfully linked). The purpose of this project is to test the feasibility of providing intensive case management to HIV-infected persons newly diagnosed at publicly funded clinics or testing locations throughout the U.S.

I. Funding Opportunity Description

Authority: Section 301(a) and 317(k)(2) of the Public Health Service Act, (42 U.S.C. 241(a) and 274b(k)(2)), as amended.

Purpose: The purpose of the program is to link HIV-infected persons recently diagnosed at publicly funded clinics in the U.S. to HIV care providers. The project is intended for communities with socio-economically disadvantaged HIV-infected persons. There are compelling personal and public health benefits to get recently diagnosed HIV-infected persons into care before they get sick. The personal benefits include delayed disease progression, early beginning of antiretrovirals, regular monitoring of their immunologic status (CD4+ cell count) and virologic status (HIV-1 RNA copies in plasma). The public health benefits include reducing HIV transmission due to earlier reduction in infectious HIV-1 RNA copies in the blood; and earlier entry into prevention for positives programs in clinical settings.

Data from the original linkage to care clinical trial ARTAS and from other research studies indicate that about 40 percent of socioeconomically disadvantaged HIV-infected individuals are not yet linked to clinical care within a year of their HIV diagnosis. The ARTAS research project showed that case managers trained in strengths-based case management methodology can facilitate entry into clinical care at a very reasonable cost. After one year, 64 percent of case managed participants and 50 percent of non-case managed participants were linked to care. Furthermore, the ARTAS model required only two to three face-to-face meetings on average with a case manager over a maximum of three months. The intent of the demonstration project is to determine how well ARTAS can be implemented locally. Data will be collected at each local site to determine success rates and costs to implement linkage case management.

The proposed project should specifically address the following objectives:

1. To assess and compare linkage to care rates in the existing referrals program with linkages rates after instituting a program of linkage case management in recently HIV-infected persons in the local area.

2. To evaluate the public health impact, including costs or cost savings from the project, on local HIV care providers and local agencies responsible for HIV diagnosis. This program addresses the “Healthy People 2010” focus area of HIV.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for HIV, STD and TB Prevention (NCHSTP): Increase the proportion of HIV-infected people who are linked to appropriate prevention, care and treatment services. Performance measure: Increase the proportion of HIV-infected people who receive some form of medical care within three months of HIV diagnosis. National target for this measure for FY 2004 is 80 percent.

Measurable outcomes will be in alignment with Strategy number three of CDC's Advancing HIV Prevention initiative: Prevent new infections by working with persons diagnosed with HIV.

Activities: Awardee activities for this program are as follows:

• To develop, in consultation with CDC, an implementation plan within 90 days of the award, which specifies how the following program activities will be carried out:

—Assess the use and availability of HIV-directed case managers in the local area and determine whether new hires, or re-directed case managers best achieve the project goals.

—Develop a recruitment plan for connecting HIV-infected persons recently diagnosed at publicly funded clinics with the case managers from this project.

—Assess the local publicly funded HIV and sexually transmitted disease (STD) testing and counseling sites in the local area to determine the optimum recruitment locations.

—Develop a tracking plan to ensure participants can be located during the entire required 12-month period.

—Enroll into the project a minimum of 50 (target: 75 percent underserved) HIV-infected persons within three months of their HIV diagnoses.

—Abstract participant medical visit and laboratory data from HIV care provider medical charts to confirm self-reported linkage to care.

• To evaluate, with the assistance of CDC, the effect of the linkage case management program on rates of use of HIV care providers compared to the existing referrals program rates.
• To evaluate, with the assistance of CDC, the overall cost of linkage case management and the cost per client served.

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:

• Provide technical guidance as needed by the project through regular site visits and group conference calls.
• Arrange separate funding for strengths-based case management training of the applicant's case managers for the project.

II. Award Information

Type of Award: Cooperative Agreement.

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

Fiscal Year Funds: 2004.

Approximate Total Funding: $1,750,000.

Approximate Number of Awards: Nine.

Approximate Average Award: $175,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Award Range: None.

Ceiling of Award Range: $275,000 (Ceiling amount will only be considered if applicant can demonstrate ability to enroll approximately 100 persons. It is anticipated that the average amount will be awarded to applicants who can demonstrate ability to enroll approximately 50 persons.)

Anticipated Award Date: September 1, 2004.

Budget Period Length: 12 months.

Project Period Length: Two years.

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.

III. Eligibility Information

III.1. Eligible Applicants

Applications may be submitted by eligible community-based organizations (CBO) or state or local governments or their bona fide Agents. Eligible CBOs must meet all criteria listed below.

A. Have tax-exempt status.

B. Be located in the area(s) where services will be provided or have provided services in the area for at least three years.

C. Demonstrate a substantial number (more than 50 percent) of clients currently served are socioeconomically disadvantaged (i.e., individuals with no health insurance or with combined annual household incomes of less than $20,000).

D. Have committed to a Memorandum of Understanding (MOU) with local health authorities that will ensure ability to recruit recently diagnosed HIV-infected persons from local health authority clinics as demonstrated by a letter from the local health authority.

Have sufficient confidential HIV testing and counseling capacity to enroll these persons as described in ‘Activities’. The executed MOU must be submitted to CDC by December 1, 2004. Failure to meet this deadline will result in suspension of funding.

E. Not be a private or public university or college, or private hospital.

F. Not be a 501(c)(4) organization.

Eligible state or local governments or their Bona Fide Agents: Recent CDC Surveillance data indicate the South comprises an increasing share of the estimated number of new AIDS cases diagnosed each year compared to the rest of the U.S. In an effort to better address this disparity by assuring better linkages to care, eligible state or local government agencies must be from one of the following states: Alabama, Arkansas, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia. If you are applying as a bona fide Agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other Eligibility Information

If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

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.

Note:

Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

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: http://www.cdc.gov/od/pgo/forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms online, 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

Letter of Intent (LOI): Your LOI must be written in the following format:

• Maximum number of pages: Two
• Font size: 12-point unreduced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid jargon

Your LOI must contain the following information:

• The proposed principal investigator(s)
• The proposed case manager(s), or from where they will be recruited
• The site(s) from which recently diagnosed HIV cases will be recruited, and their approximate demographic breakdown.

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
• Paper size: 8.5 by 11 inches
• Page 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 should address activities to be conducted over the entire project period, and must include the following items in the order listed:

• Overview or Summary
• Background and Justification of Need
• Objectives
• Project Design and Methods (including a timeline and enrollment and follow-up methods)
• Plan for Evaluation
• 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. This additional information includes:

• Letter(s) of support from medical provider(s) where participants will enroll for HIV medical.
• Curriculum vitas.
• Other letters of support.

Eligibility: Suggested length of ten pages or less.

This section will not count toward the 25 page limit of your application, but it will determine if you are eligible for funding. Place all eligibility documents demonstrating eligibility consistent with section III.1. of this announcement, in Appendix A, labeled Proof of Eligibility.

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 http://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 If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter.

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

Letter of Intent (LOI) Deadline Date: June 18, 2004.

CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.

Application Deadline Date: July 23, 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

Executive Order 12372 does apply to this program.

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. Guidance for completing your budget can be found on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

LOI Submission Address: Submit your LOI by express mail, delivery service, fax, or E-mail to: Lytt Gardner, CDC/NCHSTP, Mail Stop E-45, 1600 Clifton Rd, Atlanta, GA 30333, Telephone: 404-639-6163, Fax: 404-639-6127, E-mail: lig0@cdc.gov.

Application Submission Address: Submit the original and two hard copies of your application by mail or express delivery service to: Technical Information Management-PA# 04154, 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 objectives stated at the end of Section I of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted in the narrative of the application and will be an element of evaluation.

Your application will be evaluated against the following criteria:

1. Ability to recruit and track recently diagnosed HIV-infected persons not already linked to a care provider. Documentation to substantiate ability to recruit sufficient number of persons should be included in an attachment. (30 points)

a. Evidence of ability to recruit, during a 6-month period and using the existing referral program, at least 25 persons who were diagnosed with HIV within three months before their recruitment date. (This constitutes a “baseline” or comparison population.)

b. Evidence of ability to recruit, during a 12-month period and using the new case management program, at least 50 persons who were diagnosed with HIV within three months before their recruitment date. (This constitutes the population receiving linkage care management.)

c. Evidence of ability to recruit persons with generally poor access to health care.

d. Evidence of ability to successfully track and re-interview project participants.

e. Evidence of ability to collect complete data from project participants.

2. Documentation that the needs with respect to linkage to care of recently infected persons are not being met by existing resources. (20 points)

a. Be specific about how this need is not met by existing HRSA or CDC funding.

b. Applicants are expected to present data or credible estimates of the percentage of recently diagnosed HIV-infected persons who do not get quickly linked to a care provider.

3. Description and Justification of Project Plans (25 points)

a. Familiarity and quality of experience pertinent to proposed public health activities.

b. Understanding of project objectives and activities from Section I of this announcement, as evidenced by high quality of the proposed plan.

c. Thoroughness of plans for data management, including medical record abstraction; reasonableness of data collected; and quality control measures.

d. Capacity to conduct project as evidenced by the quality of experience with similar or related work conducted previously, including demonstration of ability to collect and manage data in a timely manner.

4. Staffing, Facilities and Timeline (25 points)

a. Availability of qualified personnel with realistic and sufficient percentage time commitments and the clarity of the descriptions of the duties and responsibilities of project personnel.

b. Adequacy of plans for project oversight to assure quality of data.

c. Letter(s) of support from medical provider(s) where participants will enroll for HIV care.

d. Adequacy of facilities, equipment, and systems for management of data security and patient confidentiality.

e. Adequacy of timeline for completion of project activities.

5. Other (not scored)

a. Budget: Is the budget reasonable, clearly justified, consistent with the intended use of funds, and allowable? All budget categories should be itemized.

b. Past Performance: Has the applicant been the recipient of funds for CDC projects in the past? If so, what was the level of performance?

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff and for responsiveness by 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.

In addition, the following factors may affect the funding decision:

• Areas of high HIV/AIDS incidence.
• Populations with unique or especially difficult circumstances.
• A balance in the number of awards between CBOs and state or local government agencies to determine feasibility of implementing this project in a variety of settings.

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-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

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, no less than 90 days before the end of the 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 and annual progress 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 or Contract 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:

Lytt Gardner, CDC/NCHSTP, Mail Stop E-45, 1600 Clifton Rd, Atlanta, GA 30333, Telephone: 404-639-6163, Fax: 404-639-6127, E-mail: lig0@cdc.gov.

For financial, grants management, or budget assistance, contact:

Charles Elder, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2889, E-mail: cfe4@cdc.gov.