Demonstration Projects for Implementation of Rapid HIV Testing in Historically Black Colleges and Universities and Alternative Venues and Populations

Announcement Type: New.

Funding Opportunity Number: 04158.

Catalog of Federal Domestic Assistance Number: 93.943.

DATES:

Application Deadline: July 23, 2004.

SUMMARY:

The purpose of this project is to demonstrate new models for diagnosing HIV infection, a priority strategy in the context of the Advancing HIV Prevention Initiative (AHP). AHP is aimed at reducing the number of new infections caused by Human Immunodeficiency Virus (HIV) each year in the United States by emphasizing greater access to HIV testing and provision of prevention and care services for persons infected with HIV. Demonstration projects will be funded to show the feasibility, and demonstrate best methods of, integrating routine HIV testing programs (including rapid testing), in a variety of venues.

Current HIV screening programs rely on individual, provider-administered assessments of risks for HIV infection, and do not identify risks which would indicate HIV testing for all HIV-infected persons. The alternative to individual risk assessment is the offering of HIV testing on a routine basis. Where routine offering of HIV testing has been utilized in areas with high HIV prevalence, the rate of HIV positive tests (two to seven percent in hospitals and emergency rooms) is similar to or exceeds that observed nationally in publicly funded HIV counseling and testing sites (two percent) and Sexually Transmitted Disease (STD) clinics (1.5 percent). HIV prevalence among persons tested in outreach settings is also consistently higher than among those tested at traditional testing clinics.

Historically, many persons tested in outreach settings never receive their test results. Because results of rapid HIV tests are available within 30 minutes, rapid HIV testing offered routinely in a variety of clinical settings and outreach efforts in nonclinical settings in high-risk communities has the potential to both reach persons at high-risk for HIV infection and to ensure that they will receive their test results.

The first part of this announcement describes a funding opportunity for demonstration projects to provide rapid HIV testing at Historically Black Colleges and Universities (HBCUs). Recent presidential proclamations support the development of research aimed at, and resources earmarked for HBCUs. There are between 102 and 118 HBCUs in the US, mostly in the South. The collective African-American student body of these schools exceeds 150,000 with an approximate age range of 18-35.

New and innovative HIV prevention programs that focus on young African American college students are needed; this is made clear by the epidemiology of HIV in the United States, and by a recently identified cluster of HIV infections among young African American male college students attending HBCUs in the South. Black males (and to a lesser extent Black females), ages 18-44 are the racial/ethnic group most disproportionately affected by HIV in the entire United States. A recent cluster of HIV infections among black male college students in North Carolina underscored the urgency of focusing attention and prevention efforts on young adults who may not have been previously or adequately served by HIV prevention programs.

CDC will use findings from these demonstration projects to design and implement HIV/AIDS prevention messages and activities in diverse settings, and serving diverse populations.

The second part of this announcement includes new strategies to identify HIV positive persons in order to provide assistance for linkage to treatment, care and prevention services. Because many newly diagnosed HIV positive persons have received care in medical settings in the year preceding their diagnosis without being offered HIV testing, diverse medical settings are the focus of the second part of this announcement. CDC will support primary care clinics, or alternative medicine clinics (homeopathic, naturopathic or chiropractic), that service high risk populations and/or communities, to develop demonstration projects to offer HIV testing to their clients. The Primary Care clinics will include, but will not to be limited to: public or private health centers; ambulatory clinics; WIC clinics; managed care organizations; or other primary care facilities, either affiliated with a university, health department, or community based organization.

The third part of the announcement focuses on Native Americans, migrant farm workers and pre-or post-operative transgendered persons. These are communities that are disproportionately affected by HIV or are at increased risk for emerging HIV epidemics because of high levels of risk behaviors associated with HIV transmission. We will fund health departments and community based organizations to create projects to demonstrate new outreach models for rapid HIV testing in these populations.

I. Funding Opportunity Description

Authority: This program is authorized under the Public Health Service Act sections 301, 311, and 317 (42 U.S.C. 241, 243 and 247(b)), as amended.

Purpose: The purpose of the program is to: (PART 1) introduce rapid HIV testing programs to serve attendees of HBCUs and Hispanic Serving Institutions (HSIs); (PART 2) develop and evaluate new models for providing rapid and conventional HIV testing into clinical venues that have not offered routine HIV screening in the past in high risk communities ; and (PART 3) introduce rapid HIV testing in clinical and nonclinical settings that serve three specific populations disproportionately affected by HIV: Native Americans, migrant worker populations, and pre-or post-operative transgendered persons. Organizations may apply for one or more parts of this announcement. This program addresses the AHP goals of CDC's initiative, Advancing HIV Prevention: New Strategies for a Changing Epidemic, aimed at reducing barriers to early diagnosis of HIV infection and increasing access to quality medical care, treatment, and ongoing prevention services for those diagnosed with HIV. This program addresses the “Healthy People 2010” focus area of identifying new HIV infections.

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): Strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs. In addition, this program addresses the Division of HIV/AIDS Prevention priorities: Develop new methods for diagnosing HIV infection, and institute integrated surveillance with emphasis on incidence, behavioral surveillance, and evaluation.

Activities: Activities for awardees under any part of this program are as follows:

• Develop a program plan in collaboration with CDC and other participating sites.
• Conduct routine HIV testing (using HIV rapid tests or conventional HIV screening tests depending on venue) in the funded facilities and for the funded populations. For these facilities, offer HIV testing to all patients between 18 and 49 years of age during the project year.
• Throughout the project, keep detailed records of barriers and successes in developing an HIV testing program within the population targeted or venue, to serve as guidance on how to create and implement similar programs in other venues.
• Collect and maintain a database of information linked to screening and confirmatory tests, including data routinely collected on patient characteristics, testing site, HIV test(s) performed, reasons for refusal of testing, modes of follow up and results of follow up, disposition of clients with confirmed positive tests with respect to services received, and other information deemed necessary by CDC and grantees. For persons with confirmed positive HIV tests, additional information will be collected at the time of receipt of confirmatory tests and at some point after (e.g., six months) to determine potential and actual barriers to access to care and other qualitative information deemed important by funded organizations, the CDC and grantees.
• Develop a plan for evaluation of the project in conjunction with CDC, and conduct evaluations of the project near the end of the project period. Evaluations may include process outcomes such as numbers of clients tested and seropositivity rates, as well as comparisons to historical data on HIV testing in the facility or a description of uptake of testing by the populations served.
• Participate in periodic conference calls, site visits and grantee meetings with other funded sites and the CDC.
• Disseminate findings jointly with CDC and other participating sites.

In addition to the above activities, grantees for Part 1 may propose the following:

• During the first 6 months of the project period, develop and conduct a focus program of formative research to determine factors or services which might contribute to increasing acceptance of testing among students attending HBCUs.

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 required program plans, protocols, evaluation plans, and data collection tools.
• Provide guidelines for HIV counseling and testing and for rapid HIV testing.
• Provide guidance and assistance in the development of data management systems and procedures.
• Facilitate conference calls, grantee meetings, and site visits.
• Assist in the analysis and dissemination of single-site and multi-site data.

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: $ 2,480,020.

Approximate Number of Awards:

Part 1: Two to three awards for the development of rapid HIV testing programs for attendees of HBCUs.

Part 2: Up to four awards for routine HIV testing in primary care clinics, community health centers, managed care organizations and alternative health clinics.

Part 3: Four to six awards for rapid HIV testing in disproportionately affected populations.

Approximate Average Award:

Part 1: Historically Black Colleges and Universities: $250,000.

Part 2: Primary care clinics and alternative health clinics: $250,000.

Part 3: Native American, migrant farm workers, and pre- or post-operative transgendered persons: $250,000.

Floor of Award Range: None.

Ceiling Award Range: None.

Anticipated Award Date: September 1, 2004.

Budget Period Length: 12 months.

Project Period Length: 12 months.

III. Eligibility Information

III.1. Eligible Applicants

Part 1. Applications may be submitted by:

• Historically Black Colleges and Universities
• Community-based organizations serving or collaborating with HBCUs

Part 2. Applications may be submitted by public and non-profit organizations, such as:

• Community-based organizations
• Primary care clinics, either free-standing or in affiliation with hospitals
• Community Health Centers
• Managed care organizations
• Private non-profit organizations

Part 3. Applications may be submitted by:

• Federally recognized Indian tribal governments
• Indian tribes
• Indian tribal organizations
• Community based organizations

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.

Part 1: For HBCUs, applicants must be colleges and universities with at least 50% Black enrollment and having a total student enrollment of at least 5,000 full and part time students. HBCUs who do not meet the minimum enrollment criteria may submit applications with strategies to include 2 or more HBCUs located in the same geographic area in order to meet minimum enrollment requirements. In this latter case, one HBCU should take the lead on developing the proposal for submission.

This announcement is not intended to provide funds to support direct instruction or curriculum implementation and training, nor are they intended to solely provide resources for HIV counseling and testing in the student health center, although this may be part of a larger strategy for providing HIV counseling and testing to this population.

For community based organizations who apply for Part 1, a letter of collaboration or support from an HBCU or HBCUs serving a total enrollment of at least 5,000 full or part time students must be included.

Part 2: Preference will also be given to programs that propose routine screening rather than targeted HIV testing or HIV testing based on risk assessment. Preference will be given to programs that propose to implement HIV testing with existing clinical staff. Additional non-clinical staff, for example for data collection or entry, may be proposed.

Health care settings that already routinely offer HIV testing to all patients (e.g., sexually transmitted disease clinics) will not be considered. Primary care clinics affiliated with hospitals and managed care organizations are encouraged to apply.

Alternative health care facilities must be able to document at least 3,000 patient visits per year, be staffed by two or more clinicians, and demonstrate that the facility serves high risk populations. Alternatively, a high HIV prevalence in the population served by the facility may be demonstrated by satisfying at least one of the criteria listed below.

High HIV prevalence may be demonstrated by: (1) HIV prevalence data demonstrating prevalence of at least one percent in the population served by the facility; (2) HIV or AIDS diagnosis rate of at least one per thousand hospital discharges for health centers and clinics in the referral network for the hospital; (3) eligibility for Title II Ryan White Care Act funds; (4) comparison data demonstrating that the facility's patient population is similar to that of other medical care facilities with HIV/AIDS prevalence rates of at least one percent; (5) demonstration that the facility serves a high risk population.

Part 3: Preference will be given to programs that propose routine screening rather than targeted HIV testing or HIV testing based on risk assessment. Preference will be given to programs that propose to implement HIV testing with existing clinical staff. Additional non-clinical staff, for example for data collection or entry, may be proposed.

For populations of Native Americans and migrant farm workers, outreach programs must be able to identify and test a minimum of 1000 persons per year in outreach or clinical settings from the population of interest, preferably using the HIV rapid test. For pre-or post-operative transgendered persons, outreach programs must be able to identify and test a minimum of 250 persons per year in outreach or clinical settings from this population. Primary care or specialty medical clinics that primarily serve these populations are encouraged to apply.

CBOs and Indian tribes are encouraged to apply and should collaborate with their respective Health Departments and other appropriate organizations. If non-tribal organizations apply to work with American Indian populations, they must show a past record of collaboration with these populations.

In addition, organizations should coordinate program activities with health department HIV/AIDS programs, and comply with all health department requirements regarding HIV counseling, testing and referral; HIV/AIDS reporting; partner counseling and referral services; and other program activities. Funded organizations should collect and report all information required by the health department related to services provided under this announcement.

Note:

Title 2 of the United States Code 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

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

• Maximum number of pages: [20] 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
• 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: Understanding of the Need; Objectives; Methods; Timeline; Evaluation Plan; Staff; Budget and Justification.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes: resumes of key staff; staffing plans; training agreements and other memoranda of understanding to assure that linkages with other appropriate organizations are in place; descriptive information regarding the applicant's organization or affiliated programs, i.e., pamphlets, brochures, other documents; appropriate reference materials to support applicant's application, i.e., publications concerning risk within the communities served by the organization; references from other funding organizations that have previously funded the applicant for HIV prevention projects.

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. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. 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

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

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:

• Awards will not allow reimbursement of pre-award costs.

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.

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

Application Submission Address: Submit the original and two hard copies of your application by mail or express delivery service to: Technical Information Management-PA# 04158, 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.

Your application will be evaluated against the following criteria, whether you are applying to Part 1, Part 2 or Part 3:

1. Methods (40 points): Are the proposed methods feasible? Will they accomplish program goals? Can the proposed methods for offering routine testing be sustainable by existing staff after the project period (especially important for Part 2)? Does the applicant describe a plan for routinely recommending voluntary HIV testing in the identified setting or to the identified populations; the process for promoting and offering rapid or conventional HIV tests; the setting in which HIV counseling, testing, and referral services will be provided; clearly defined mechanisms for referral into care, treatment, and prevention services for patients testing positive for HIV; training for project staff; a reasoned approach of how to contact clients when necessary to ensure receipt of confirmatory test results for all positives; and a system for reporting HIV-positive test results to the health department, where required? Is a time line with realistic and measurable milestones for major project activities provided?

2. Capacity (20 points): Does the applicant have the appropriate facilities and staff to conduct this program? Is adequate and objective information provided to demonstrate the availability of sufficient numbers of clients and sufficient prevalence of HIV risk behaviors or rates of seroprevalence in the populations being targeted? Is the project director well qualified, by education and experience, to lead the project team, hire and train appropriate staff, and provide programmatic and scientific oversight? Has the applicant established relationships to assure oversight, supervision, and regulatory compliance for rapid HIV testing?

3. Objectives (20 points): Are the objectives reasonable, time-phased and measurable? Does the applicant provide reasonable methods to evaluate their progress toward the timely accomplishment of objectives?

4. Evaluation (20 points): Are evaluation methods described? Are the outcome measures clearly related to the objectives? Are the types of process and outcome data proposed in the evaluation plan readily collected? To determine the effectiveness of the program, does the applicant have access to counseling and testing data for their area to serve as a comparison group; or does the applicant intend to use data from existing counseling and testing programs within the proposed venue(s) as a comparison group; or does the applicant intend to compare different methods of delivering counseling and testing programs to a particular population or in a particular venue?

5. Budget (not scored): Is the budget reasonable for the proposed activities? Does the budget allow for sufficient time—approximately three to six months—for the development of the program plan and review by CDC and other entities?

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 National Center for HIV/STD/TB Prevention, Division of HIV/AIDS Prevention. 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.

Applicants may apply for any or all of the target populations or settings. A separate application should be submitted for each setting or population proposed. Applications from each target population will be evaluated independently by the objective review panel and will be ranked against applications from the same target population according to the Evaluation Criteria.

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

Preference will be given to applicants who propose settings which will provide a diverse ethnic, racial or risk population with regard to the overall selection of venues participating in the demonstration projects.

V.3. Anticipated Announcement and Award Dates

Awards will be issued on or about 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-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-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-24 Health Insurance Portability and Accountability Act Requirements

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 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: Scott Kellerman, MD, MPH, Extramural Project Officer, 1600 Clifton Road, MS E-46, Atlanta, Georgia 30333, Telephone: 404-639-4484, E-mail: SKellerman@CDC.GOV.

For financial, grants management, or budget assistance, contact: Betty Vannoy, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2897, E-mail: bbv9@cdc.gov.