03-17304. Viral Hepatitis Integration and Intervention Projects; Notice of Availability of Funds

Application Deadline: October 7, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301(a) and 317(k)(1) and 317(k)(2) of the Public Health Service Act, (42 U.S.C. 241(k) and 247b(k)(1) and 247(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2004 funds for a cooperative agreement program for Viral Hepatitis Integration and Intervention Projects. This program addresses the “Healthy People 2010” focus area of Immunization and Infectious Diseases.

The purpose of this program is to (1) improve the delivery of existing viral hepatitis prevention services in programs known to serve adults and adolescents at high risk for infection (e.g. Sexually Transmitted Disease (STD) clinics, Human Immunodeficiency Virus (HIV) counseling and testing sites, health care programs serving correctional facilities, primary health care settings, substance abuse prevention or treatment centers); (2) evaluate the effectiveness of different strategies to deliver recommended hepatitis preventive services (e.g. vaccination, testing and counseling, receipt of test results, and medical and other appropriate services for infected persons); (3) evaluate the impact of integration of viral hepatitis prevention services on existing prevention services (e.g., STD or HIV counseling and testing); (4) to conduct research to identify, develop and evaluate specific programmatic interventions and approaches to achieve successful integration of recommended preventive services and increase levels of coverage for these services; and (5) to produce materials that convey to other public health programs the lessons learned with respect to integration of viral hepatitis prevention activities into existing public health and clinical care programs.

Recommendations for prevention and control of hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV) among adults and adolescents at high risk of infection have been published by CDC (references 1-6, Appendix II, as posted with this announcement on the CDC web site). The primary goals of these recommendations are to decrease the incidence of acute viral hepatitis infections and to decrease the risk of complications from chronic infection with HBV or HCV among populations known to be at high risk for infection. Despite effective vaccines to prevent both HAV and HBV infections, and known behavioral changes necessary to prevent infection with HCV and the serious consequences of chronic HBV or HCV infection, new infections and adverse outcomes of chronic infection continue to occur among high risk adults and adolescents.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center for Infectious Diseases (NCID): Protect Americans from Infectious Diseases; National Immunization Program (NIP): Reduce the number of indigenous cases of vaccine preventable diseases; and National Center for HIV, STD, and Tuberculosis (TB) Prevention (NCHSTP):

Increase the proportion of HIV-infected people who are linked to appropriate prevention, care, and treatment services and strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs.

C. Eligible Applicants

Assistance will be provided only to the health departments of States or their bona fide agents and territories, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, the Republic of Palau, and federally recognized Indian tribal governments and political subdivisions of states (in consultation with States).

This limited eligibility is due to the requirement that viral hepatitis services be integrated with existing state or local public health programs.

State or local health departments are encouraged to partner with academic institutions in developing proposals for this announcement.

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.

D. Funding

Availability of Funds

Approximately $2,900,000 is available in FY 2004 to fund approximately seven awards. It is expected that the average award will be $400,000 ranging from $300,000 to $500,000. It is expected that the awards will begin on or about January, 1, 2004, and will be made for a 12-month budget period with a project period of up to five years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds

Cooperative agreement funds may be used to support personnel, purchase supplies, services, and travel directly related to program activities and consistent with the scope of the cooperative agreement. Funds under this program announcement may not be used to provide direct patient treatment services. Supplies may include, but are not limited to those for laboratory testing and hepatitis A and B vaccine for adults (any adolescents included in the projects may be eligible for free vaccine under the Vaccines for Children program), although other sources of funding for these essential supplies need to be sought. Computers and related technologic needs should be requested under supplies, not equipment, if less than $25,000. Consultants and sub-contracts (e.g., with academic or other institutions) may be requested as appropriate. Federal funds awarded under this program announcement may not be used to supplant State or local funds.

Recipient Financial Participation

Matching Funds are not required for this program.

Funding Preferences

Preference will be given to programs that currently deliver viral hepatitis prevention services (e.g., hepatitis A and or hepatitis B vaccination services, hepatitis C counseling, testing, medical referral or case management for HCV positive persons) through an existing program serving adults (may also serve adolescents) at high risk for infection with hepatitis viruses, and are seeking to evaluate or improve these services. Such existing programs include, but are not limited to STD Clinics, HIV/AIDS counseling/testing sites, correctional health care settings, substance abuse treatment programs accessing and providing services to injection drug users (IDUs), and primary care health settings that are known to serve high risk populations.

Preference will be given to programs that are able to determine the proportion of clients in their selected health/prevention delivery service setting who have known risk factors for infection with HBV, HCV, HAV or HIV (e.g., percent of clients served who are IDUs), and the proportion of clients who accept and receive recommended disease-specific prevention services (e.g., percent of IDUs who receive 1st, 2nd,and 3rd doses of hepatitis B vaccine or are tested for HCV infection, receive results, and, if HCV positive, undergo medical evaluation or other recommended services such as drug treatment if appropriate).

Preference will be given to ensure a diversity of settings for delivery and evaluation of integrated prevention services. Applicants should specify one specific type of setting in which to concentrate efforts to improve and evaluate delivery of recommended services.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities.

1. Recipient Activities:

a. Develop and implement a plan to improve the delivery of recommended viral hepatitis prevention services in an existing public health or primary care setting that serves known high risk adults and/or adolescent populations, as appropriate for the particular setting proposed. References for current recommendations and integration experiences are included in Appendix II (as posted with this announcement on the CDC website). Core viral hepatitis prevention services should include:

(1) Assessment of risk factors for viral hepatitis among all clients.

(2) Performing appropriate testing of persons for HCV and HBV infection and appropriate pre-vaccination testing for immunity to HBV and/or HAV infection.

(3) Client-centered viral hepatitis prevention counseling.

(4) Hepatitis B vaccine for persons in appropriate risk groups (e.g., persons at risk of sexual transmission, including STD clients and men who have sex with men [MSM]; incarcerated persons; IDUs; and sex and household contacts of persons with chronic HBV infection).

(5) Hepatitis A vaccine to persons in appropriate risk groups (e.g, MSM, illegal drug users).

(6) Delivery of primary prevention services for anti-HCV positive and HBsAg-positive persons, including: (a) Counseling on how to prevent transmission to others, (b) identification of partners (sex and/or needle-sharing) for counseling and referral services, if appropriate, and (c) providing hepatitis B vaccine for at-risk (sex or needle-sharing) partners and household contacts of HBsAg-positive persons.

(7) Either directly or by referral, provide appropriate follow-up services to persons found to be anti-HCV or Hepatitis B Surface Antigen (HBsAg) positive, including: (a) Alcohol and drug counseling and/or treatment, and (b) medical evaluation for chronic liver disease and possible treatment, including assistance in accessing medical care.

b.Monitor and evaluate prevention activities and intervention strategies, including:

(1) Develop and provide a written plan to assess the success of strategies to improve hepatitis prevention service delivery (measuring both process and outcome components).

(2) Implement the evaluation plan, including appropriate data collection and analysis, interpretation, and cost-effectiveness analyses. Of particular interest is to determine rates (at baseline and following intervention efforts) for services offered and accepted among clients, including:

(a) HIV and HCV testing among clients recommended for testing.

(b) Receipt of test results (STD, HIV, hepatitis).

(c) HIV positives identified, HCV positives identified, co-infections identified (or persons confirmed negative for one disease or both);

(d) New and chronic infections with other STDs (e.g., syphilis, herpes) identified.

(e) Follow up (which may be provided directly or by referral) for persons infected with HIV or HCV (e.g., appropriate evaluation and treatment for HIV disease, medical evaluation in HCV-positive persons, substance abuse treatment when indicated, or other appropriate services; and outcome(s) of referral and follow up.

(f) Dose-specific hepatitis A and hepatitis B vaccination coverage for persons for whom vaccine is recommended.

c. Provide staff training regarding viral hepatitis prevention and control, including specialty training required to implement specific activities of the program.

d. Participate in at least two national meetings (CDC, or Division of Viral Hepatitis (DVH), NCID-sponsored, including DVH sponsored National Hepatitis Coordinators Conference) during each budget year of the project period for the purpose of improving and sharing methods to achieve project goals and to plan, present and evaluate program activities.

e. Develop and implement a plan to disseminate the findings and outcomes of the proposed projects, including guidelines for the implementation of successful integrated prevention activities, presentations at state-wide and national health professional meetings, and publication of findings and recommendations.

2. CDC Activities:

a. Collaborate directly in the design and implementation of studies and interventions to evaluate and improve delivery of recommended hepatitis prevention services integrated into existing programs to deliver prevention services.

b. Collaborate directly in the ongoing and expanded training of staff in viral hepatitis.

c. Collaborate directly in data analysis, including economic analysis, interpretation, and presentation and publication of project findings.

d. Coordinate annual meeting of project managers or state and local hepatitis coordinators to plan, present, and evaluate program activities.

e. Collaborate directly in the publication dissemination of successful findings and experiences.

f. Assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

F. Content

Letter of Intent (LOI)

An LOI is optional for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than two pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font. Your LOI will be used to assist CDC in planning for and executing the evaluation of applications submitted under this Program Announcement and should include the following information, the name of the principle investigator(s); the name, address, telephone, e-mail address, and fax number of the applicant's primary contact for writing and submitting the application; the setting proposed to evaluate the intervention/integration and evaluation of services for high risk adults and adolescents (e.g., STD clinic, HIV Counseling and Testing Sites (CTS), correctional health care, substance abuse, primary care program); a brief description of the hepatitis services currently available in the proposed setting; the proposed strategy(ies) to improve these services; and the name(s) of proposed collaborators (e.g., academic partners).

Applications

Beginning October 1, 2003, applicants will be required to have a Dun and Bradstreet (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.

Although obtaining a DUNS number is not required for applications submitted in response to announcements with deadlines on or before September 30, you are encouraged to obtain a DUNS number now if you believe you will be submitting an application to any Federal agency on or after October 1, 2003. Proactively obtaining a DUNS number at the current time will facilitate the receipt and acceptance of applications after September 2003. To obtain a DUNS number, access: www.dunandbradstreet.com or call 1-866-705-5711.

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 25 pages, double-spaced, printed on one side, with one-inch margins and unreduced 12-point font. The narrative should consist of a Plan, Objectives, Methods, Evaluation, and Budget. The program plan should address activities to be conducted over entire five year project period. See all attachments posted with this announcement on the CDC web site for more detailed information on development of the application content.

G. Submission and Deadline

Letter of Intent (LOI) Submission

On or before July 24, 2003, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

CDC will host a voluntary pre-application conference call for all interested parties to answer any questions about this announcement or application process. To participate, interested parties must contact the program technical assistance contact within two weeks of the publication of the program announcement in the Federal Register.

Application Forms

Submit the signed original and two copies of PHS form 398 (OMB Number 0925-0001); adhere to the instructions on the Errata Instruction Sheet (posted on the CDC web site) for PHS 398. Forms are available 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) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time, October 7, 2003. Submit the application to:

Technical Information Management—PA#04009, Procurement and Grants Office, 2920 Brandywine Rd., Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgment of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received 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, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Applicants 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 as stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These Measures of Effectiveness shall be submitted with the application and shall be an element of evaluation.

An independent review group appointed by CDC will evaluate the application against the following criteria:

1. Project/Research Design and Methods (45 points): The design of the proposal's intervention(s), activities and methods to evaluate the outcomes or effectiveness of their proposed intervention strategies will be scored as follows:

(a) The extent to which the applicant provides Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. The degree to which the measures are objective/quantitative and adequately measure the intended outcome. Quality of the plan to evaluate the success (outcomes) of proposed strategies to improve service delivery and integrated services. This should include the appropriateness of the proposed evaluation method for the chosen intervention(s) or activities, the potential generalizability of the findings to other similar settings, and the impact of the intervention(s)/integration on other services being delivered at the site (e.g. HIV counseling and testing services). (20 points)

The following outcome measures are of specific interest:

(1) Changes in rate of persons seeking services in selected venues who truly have high risk behaviors for recommended services.

(2) Changes in rates of STD, HIV, HCV tests accepted by persons recommended for testing.

(3) Changes in rates of receipt of test results (with and without counseling).

(4) Changes in rates of HIV and HCV positive persons identified, co-infections identified (or confirmed negative for one disease or both).

(5) Changes in rates of new and chronic infections with other STDs (e.g., syphilis, herpes).

(6) Changes in rates of success and follow up (which may be direct or by referral) for persons infected with HIV or HCV (e.g., getting appropriate evaluation and treatment for HIV disease, getting medical evaluation for evidence of chronic liver disease in persons found to be HCV positive, getting into substance abuse treatment, or other appropriate services).

(7) Changes in rates of offering hepatitis A and hepatitis B vaccination to persons for whom vaccine is recommended.

(8) Changes in rates of vaccine acceptance among these clients (and reasons for refusal).

(9) Changes in rates of completion for each dose of hepatitis A and hepatitis B vaccine among clients recommended for and accepting vaccine.

(b) Consistency with the CDC Evaluation Framework for Evaluating Public Health Programs (see Appendix III as posted with this announcement on the CDC web site) and inclusion of a clear logic model (or other appropriate tool) for the proposed program that clearly identifies process and outcome measures (indicators). (5 points)

(c) Quality of methods to be used to evaluate the implementation of the interventions used in the proposed program (process evaluation). (5 points)

(d) Indication of how the evaluation will be used to improve program services. (5 points)

(e) Indication of how evaluation will be institutionalized as a normative, ongoing activity. (5 points)

(f) If research involving human subjects is proposed, the degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes: (1) the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) the proposed justification when representation is limited or absent; (3) a statement as to whether the design of proposed studies is adequate to measure differences when warranted; and (4) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community/ies and recognition of mutual benefits. The extent to which applicant describes the existence of or plans to establish partnerships. (5 points)

2. Background and Significance (30 points):

(a) Extent to which applicant demonstrates that one or more hepatitis prevention activities are provided to at least five percent of clients seeking services in the proposed setting for whom prevention services are currently recommended (e.g., at least five percent of STD clients receive hepatitis B vaccine; at least five percent of persons reporting IDU past or current receive anti-HCV counseling and testing). (10 points)

(b) Extent to which applicant demonstrates maximized use of existing resources and staff to integrate viral hepatitis prevention services, which clearly and appropriately addresses all “Recipient Activities” in the application; including (directly or through collaboration) adequately trained personnel (technical, administrative, and analytic), adequate facilities, research capacity including Institutional Review Board (IRB), adult vaccine supply (at least partial), and laboratory testing (at least partial) for beginning the project. (5 points)

(c) Extent to which the applicant demonstrates adequate numbers of clients or at-risk population, (based on risk factors or other denominators) to achieve the objectives of the proposed evaluation or intervention. Projects should be of a size that represents populations served annually in medium to large clinics (e.g. average at least 3000/year). (5 points)

(d) Extent to which applicant documents experience of proposed personnel, either direct or collaborating, in developing, implementing, and evaluating strategies to improve clinical prevention services for high risk adults and likely has the capacity to do so for viral hepatitis prevention and control activities and services (e.g., training, testing, counseling, vaccination, clinical services). (5 points)

(e) Evidence of existing quality assurance mechanisms to insure appropriate counseling and other services as recommended for the proposed setting, as provided by published CDC guidelines in various settings (e.g. STD, HIV, Substance Abuse Treatment). (5 points)

3. Preliminary Studies (10 points): Quality of existing summarized data from proposed setting to demonstrate potential outcomes pertaining to the project.

4. Specific Aims (10 points): Extent to which the applicant describes objectives of the proposed project which are consistent with the purpose and goals of this cooperative agreement program, results oriented, realistic, measurable and time-phased, and consistent with published CDC guidelines on prevention and control of hepatitis C (MMWR 1998;47 [No. RR-19]), hepatitis B (MMWR 1991;40 [No. RR-13]) and hepatitis A (MMWR 1999;48 [No. RR-12]). Sexually Transmitted Diseases Treatment Guidelines (MMWR 2002;5 [No. RR-06]). In addition to these three references, additional relevant CDC guidelines that should be followed include those listed in Appendix II (as posted with this announcement on the CDC Web site).

5. Other (5 points): Extent to which the applicant clearly identifies specific assigned responsibilities of all key professional personnel, and includes a clear time-line for activities.

6. Human Subjects (not scored): Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

7. Budget (not scored): The budget will be reviewed to determine the extent to which it is reasonable, clearly justified, consistent with the intended use of funds, and allowable.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

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 Activity Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

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.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see all attachments posted on the CDC Web site.

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-6 Patient Care

AR-7 Executive Order 12372

AR-9 Paperwork Reduction Act

AR-10 Smoke Free Work Place Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

AR-22 Research Integrity

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone].

For business management and budget assistance in the states, contact: Yolanda Sledge, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone]. E-mail Address: [e-mail]

For business management and budget assistance in the territories, contact: Charlotte Flitcraft, Contract Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone], Email Address: [e-mail]

For program technical assistance, contact: Joanna Buffington, MD, MPH, Mailstop G-37, Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA 30333, Telephone: [phone], E-mail address: [e-mail].

Dated: July 1, 2003.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.