03-14128. Minority Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) Research Initiative To Build Capacity in Black and Hispanic Communities and Among Researchers Who Conduct HIV/AIDS Epidemiologic and Prevention Research in ...

Application Deadline: August 4, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under 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. The Catalog of Federal Domestic Assistance number is 93.943.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program called the Minority HIV/AIDS Research Initiative (MARI) that is funded by the Minority AIDS Initiative (MAI). The MARI program has been established to build capacity for HIV epidemiologic and prevention research in Black and Hispanic communities and to promote the independent research careers of HIV/AIDS investigators working in these communities. In addition, MARI aims to engage in capacity building among researchers at Historically Black Colleges and Universities, Hispanic Serving Institutions and Hispanic Serving Health Professions Schools as stipulated in Federally promulgated Executive Orders 13256 and 13230, respectively. You may reference these Executive Orders at the following Web Sites: http://www.whitehouse.gov/​news/​releases/​2001/​10/​20011012-10.html and http://www.whitehouse.gov/​news/​releases/​2002/​02/​20020212-3.html

This initiative addresses the “Healthy People 2010” focus area of HIV as well as the CDC's HIV prevention strategic plan through 2005. The overarching national goal stated in the CDC's HIV prevention strategic plan is to reduce the number of new HIV infections in the U.S. by 50 percent by 2005 by focusing on eliminating racial and ethnic disparities in new HIV infections. The CDC 2001 year-end HIV/AIDS surveillance report, which outlines the racial disparities in HIV/AIDS, reveals that Blacks and Hispanics together represented 57 percent of reported AIDS cases and 62 percent of reported HIV cases in 2001. Furthermore, of the new HIV cases in 2001, 58 percent of Black and Hispanic men and approximately 40 percent of Black and Hispanic women had unknown or unreported risk upon presentation for HIV testing. These statistics highlight the urgent need for HIV epidemiologic and prevention research in Black and Hispanic populations that are at-risk for HIV infection.

The goals of the MARI program are to:

(1) To build HIV prevention research capacity in Black and Hispanic communities in which insufficient research has been conducted by partnering with and developing new investigators from these communities to address pertinent research questions.

(2) To engage in career development and provide research opportunities for new investigators from Black and Hispanic communities through collaboration with the Division of HIV/AIDS Prevention at CDC. This will be achieved by encouraging these scientists to develop independent research skills needed to gain experience in HIV epidemiologic and prevention research, to present the results of their research at national conferences and to publish their results in peer-reviewed journals.

(3) Develop and conduct HIV epidemiologic prevention research, in the form of limited case-control, cross-sectional or qualitative projects that have public health relevance to Black and Hispanic communities.

Measurable outcomes of the program will be in alignment with the following performance goals for the National Center for HIV, STD and TB Prevention (NCHSTP):

(1) Decrease the number of persons at high risk for acquiring or transmitting HIV infection;

(2) Increase the proportion of HIV-infected people who know they are infected;

(3) Increase the proportion of HIV-infected people who are linked to appropriate prevention, care, and treatment services; and

(4) Strengthen the capacity to develop and implement effective HIV prevention interventions.

Given the goals of MARI and the CDC's HIV strategic plan, this program announcement calls for epidemiologic and prevention research that will advance scientific knowledge about HIV transmission, testing and treatment patterns, as well as social and environmental factors that influence risk behaviors in Black and Hispanic communities. This announcement specifically invites applications addressing a variety of scientific research topics outlined below in sections “I” and “II”.

Section I

Participation of Minorities in Government-Sponsored Research

The participation of communities of color in HIV vaccine research is critical to ensuring that HIV vaccine candidates are effective across diverse racial and ethnic groups and that all groups have equal access to eventual vaccines. Community-based studies are needed to understand facilitators and barriers related to participation in government-sponsored research, which may include examination of the following: (1) Perceptions of AIDS in relationship to other community health issues, (2) community and individual attitudes of research related to HIV/AIDS, particularly vaccine trials, (3) the relationship between socioeconomic status, stigma, and disenfranchisement to research involvement, (4) strategies for enhancing community partnerships in the support and conduct of research, and (5) the historical context of government-sponsored research in minority communities such as the Tuskegee Syphilis Study.

Voluntary HIV Testing and Counseling of Young Men Who Have Sex with Men (MSM)

Recent data indicate that up to 90 percent of young MSM of color who are infected with HIV are unaware of their seropositive status. Other studies indicate that HIV+ men who become aware of their status substantially reduce their sexual risk behaviors. Studies are needed to increase HIV testing among young MSM of color who are at risk for transmitting or contracting HIV and to determine motivating factors in the desire to seek HIV testing. Of particular interest are studies that test different types of persuasive communications to promote HIV testing in this population.

Prevalence of Intravenous Drug Use (IDU) Related HIV in the Southeast

The epidemiology of the HIV among intravenous drug users has been well defined in the United States, with the exception of the Southeast region. Epidemiologic and surveillance studies are needed to assess the prevalence, incidence and risk factors for HIV infection among Southeastern U.S. intravenous drug users. In addition, data are needed to quantify the seroprevalence of Hepatitis B and C and attendant risks for acquisition of these diseases in southern populations.

Missed Opportunities for Prevention of Perinatal Transmission

Perinatal transmission in the U.S. has been drastically reduced since 1993. However, greater than 75 percent of babies with HIV continue to be born to Black and Hispanic mothers. Elimination of perinatal transmission can only be achieved by reducing missed opportunities that occur among these women and by addressing issues associated with failures of prevention efforts. Reasons for these missed opportunities and prevention failures vary and warrant investigation. Studies are needed to understand why prevention failures occur among Black and Hispanic women and infants who access the required services and to address the reasons that these mothers and infants may not access prevention services required to reduce perinatal transmission.

Section II

Behavioral, Psychosocial, and Cultural Determinants of HIV Risk Behavior

The majority of HIV prevention research in the U.S. has been conducted in gay, white male populations. Consequently, many of the current prevention interventions have been informed and developed based on data from this population. Qualitative and quantitative studies of Black and Hispanic populations are needed to understand the unique psychological, social, and cultural factors that influence HIV-related knowledge, attitudes, perceptions and behaviors in these minority populations. Studies are needed to understand a wide-range of issues including but not limited to perceptions of risk, injection drug use, sexual risk-taking, response to HIV prevention messages, decisions to seek HIV testing and counseling, and decisions to seek HIV care and related treatment. Specific areas of interest include:

(1) Effect of social, community (including religious influences), and family dynamics on attitudes, knowledge, risk perceptions, and willingness to seek HIV testing.

(2) The role of gender and sexual identity and their relationship to HIV attitudes and risk behaviors.

(3) How social, economic, and cultural environments influence attitudes about HIV, response to prevention messages, and behavior change.

(4) The role of social and sexual networks in HIV transmission.

(5) Pilot studies to assess explanations for disparities in HIV rates in minority populations.

(6) Identification of factors associated with sexual- and drug-risk behavior in persons of color who have tested positive for HIV.

Treatment Adherence

Studies are needed to understand many aspects of treatment adherence in Black and Hispanic HIV-infected patients such as (but not limited to), its relationship to mental illness, patient/provider concordance and/or relationships, pill burden and structural barriers impacting adherence.

Biological Disparities

Ethnicity may play a role in the biological and immunological responses to HIV, as well as the responses to treatment and therapy for opportunistic infections. Studies are needed to determine the role of immunology, virology and the host response(s) in any of these areas.

C. Eligible Applicants

• Applications may be submitted by:
• Public nonprofit organizations
• Private nonprofit organizations
• For profit organizations
• Small, minority, women-owned businesses
• Universities
• Colleges
• Technical schools
• Research institutions
• Hospitals
• Community-based organizations
• Faith-based organizations
• Federally recognized Indian tribal governments
• Indian tribes
• Indian tribal organizations
• State and local governments or their bona fide agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
• Political subdivisions of States (in consultation with States)

The primary investigator from the applying entity must also meet and be able to demonstrate the following additional requirements:

(1) Possession of a research or a health-professional masters or doctorate-level degree from an accredited school/program;

(2) Have never been a primary investigator on a National Institute of Health (NIH) R-01 award for $250,000 or greater;

(3) Be knowledgeable about HIV/AIDS epidemiology and prevention, as well as have basic but minimal research experience in or related to the field of HIV/AIDS;

(4) Have a documented history of working in Black and Hispanic communities;

(5) Have documented linkages to Black and Hispanic communities that are impacted by HIV;

(6) Have the ability to establish effective and well-defined working relationships with community advisory boards, community-based organizations or similar entities which will ensure appropriateness of proposed research and implementation of the proposed activities. The investigator must demonstrate efforts to develop this relationship by submitting letters of support or equivalent statement(s); and

(7) Demonstrate willingness to partner with HIV epidemiologic and prevention researchers at CDC to ensure timely development of protocols and study instruments, submission of protocols to required human subjects review boards, conduct of investigations and to analyze, present and publish study results.

Documentation of the above requirements must be included in the application. This includes, but is not limited to letters indicating involvement in HIV/AIDS research or HIV/AIDS-related publications, curriculum vitas and/or letters of support.

Applications are encouraged from organizations that serve predominantly racial and ethnic minority populations that are disproportionately impacted by HIV/AIDS or those who are representative of the minority communities targeted in this program announcement.

D. Funding

Availability of Funds

Approximately $1.4 million is available in FY 2003, to fund approximately six to ten awards. Up to five awards may be granted for each section “I” and “II”. It is expected that the average award will be $200,000, ranging from $75,000 to $300,000. The awards will begin on or about September 15, 2003 and will be made for a 12-month budget period within a project period of one to three 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.

Funding Priority

Priority will be given to:

(1) Projects that demonstrate strong community partnerships and access to predominantly Black and Hispanic communities that are disproportionately affected by the HIV/AIDS epidemic.

(2) Projects that are cross-sectional or pilot in nature and that will require one to three years of funding to ensure the availability of funding for a greater number of applicants.

Funding Preferences

Preference will be given to applicants that:

(1) Have the ability to implement culturally and linguistically competent methodology within the study design;

(2) Have a history of service to Black and Hispanic communities;

(3) Are indigenous to the targeted population; and

(4) Have linkages to the targeted population.

Funding decisions will attempt to achieve regional diversity. Preference will be given to proposals addressing HIV prevention needs in Black and Hispanic communities with the highest rates of HIV. In addition, preference will be given to proposals targeting areas with increasing rates of HIV such as the Southeast.

Recipient Financial Participation

Matching funds are not required for this program.

E. Program Requirements

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

1. Recipient Activities

a. Collaborate with CDC researchers and community-based organizations or similar community liaisons for duration of project period on several activities such as development of data collection instruments, specimen collection protocols, and data management procedures.

b. Identify, recruit, obtain informed consent form, and enroll an adequate number of study participants as determined by the study protocols and the program requirements.

c. Follow study participants as determined by the study protocols.

d. Establish procedures to maintain the rights and confidentiality of all study participants.

e. Perform laboratory tests (when appropriate) and data analysis as determined in the study protocols

f. Present and publish research findings

g. Participate in conference calls with CDC project officer(s) and research team

h. Attend initial and annual meetings with other MARI-funded grantees to promote research dissemination and networking among investigators.

2. CDC Activities

a. Provide technical assistance in the design and conduct of the research.

b. Facilitate and 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.

c. Assist in designing a data management system.

d. Assist in performance of selected laboratory tests.

e. Assist in the analysis of research data information and the presentation and publication of research findings.

f. Conduct site visits to ensure that venues are properly selected, collaborations outlined in proposals are true and that the community is involved in the research activities, and that investigators are complying with the research protocol.

g. Conduct initial and annual meetings of MARI-funded investigators to facilitate the exchange of research progress among recipients and to offer additional technical expertise for the conduct of research.

F. Content

Letter of Intent (LOI)

A LOI is required for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than one page, single-spaced or two pages double-spaced. Your letter of intent will be used to assess the number of applications to anticipate, plan the review process more effectively and efficiently, and determine the level of interest in the MARI goals and objectives.

Your letter of intent should include the following information: Name, address and affiliation of the primary investigator, a brief description of the scope and intent of the proposed research, any plans/provisions to collaborate with community agencies.

Applications

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 12-point font.

The narrative at a minimum should include a plan, objectives, methods, evaluation, budget and timeline.

The program plan should address activities to be conducted over the entire one to three-year project period. The budget must cover the first one-year budget period.

G. Submission and Deadline

Letter of Intent (LOI) Submission

On or before June 15, 2003, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application Forms

Submit the signed original and two copies of PHS 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: 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 on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section 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 August 4, 2003. Submit the application to: Technical Information Management—PA# 03097, CDC Procurement and Grants Office, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

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

Deadline

Letters of intent and 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. Applicants will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of MARI or cooperative agreement. Measures of effectiveness must relate to the performance goals as stated in section “B. Purpose” 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 each application against the following criteria:

(1) Description and Justification of Research Plan, Objectives and Methodology (35 points)

a. Applicability and relevance of study objectives to Black and Hispanic communities.

b. Integration of culturally competent and relevant study methodology for Black and Hispanic communities.

c. Study questions address gaps in the HIV/AIDS research literature or build on the findings of previously conducted research in Black and Hispanic populations.

d. Applicant's understanding of research objectives as evidenced by the quality of the proposed research plan and specific study design and methods.

e. Feasibility of plan to sample, recruit and enroll study participants in a culturally appropriate manner and design study instruments that are culturally appropriate to Black and Hispanic populations.

f. Plan to ensure confidentiality of participants.

(2) Familiarity with and access to Black and Hispanic communities most adversely and disproportionately affected by the HIV/AIDS epidemic (30 points)

a. Experience conducting research and working in Black and Hispanic communities.

b. Ability of the investigator to identify with Black and/or Hispanic populations at-risk for HIV.

c. Extent of applicant's knowledge of issues faced by Black and/or Hispanic communities affected by HIV.

d. Demonstrable ability to recruit study population and obtain valid data through the use of culturally appropriate methods and instruments.

(3) Demonstration of community collaboration during study design, recruitment and project implementation. (20 points)

a. Evidence of plan for establishing a partnership with at least one community organization to consult on all aspects of conducting the study and to link participants with prevention and medical services as needed.

b. Evidence that plans for recruitment and outreach for study participants will include establishing partnerships with communities.

c. Feasibility of plans to involve the study population, their advocates, or service providers in the development of research activities and to inform them of research results.

(4) Demonstration of Capability to Conduct Research (15 points)

a. Applicant's ability to carry out the proposed research as demonstrated by the experience of the principal investigator and the proposed research team and organizational setting.

b. Demonstration of epidemiologic, behavioral, clinical, laboratory, administrative, and management expertise needed to conduct the proposed research.

c. Demonstration that principal investigator and staff have experience working with the targeted population of study participants.

Budget (reviewed, but not scored)

Extent to which budget is reasonable, itemized, clearly justified and within funding limits of this program announcement.

Human subjects: (not scored)

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects?

Does the application adequately address 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 the study is adequate to measure differences when warranted.

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.

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 Activities 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 Attachment I of the program announcement as 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-5 HIV Program Review Panel Requirements

AR-6 Patient Care

AR-7 Executive Order 12372 Review

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

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, contact: Carlos Smiley, Grants Management Officer, 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 program technical assistance, contact: Lisa K. Fitzpatrick, MD, MPH, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd. #E-45, Atlanta, GA 30333, 404-639-5166.

Dated: May 30, 2003.

Edward Schultz,

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