CFAR Competitive Supplements in AIDS - FY2005 Awards

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PURPOSE

As described in the 2003 CFAR Program Announcement - the CFAR Program at the National Institutes of Health (NIH) will accept applications from current CFARs for competitive supplements of up to $150,000 in direct costs in the six research areas identified below. The NIH expects to make from nine to 15 scientific awards based on budget requests received, and funding availability. Applicants may request only one year of funding. Applications should address one or more of the following specific AIDS research priority areas:

• Area 1: International. Collaborations with colleagues from developing countries on specific AIDS projects that will enhance the international capabilities of the CFARs, and the development of sustainable research capacity in the developing country. Supplements for countries in central and Eastern Europe, the former Soviet Union and countries in Africa, the Americas, Asia (except Japan, Singapore, South Korea and Taiwan), the Middle East (except Israel) and the Pacific Region (except Australia and New Zealand) will be considered responsive to this request. Studies in Ethiopia, Nigeria, Russia, China, and India are especially encouraged. All AIDS-related scientific studies, including forward thinking applications that address HIV-related care, risk behavior, and prevention, will be considered responsive. International studies that involve the other specific AIDS research areas below are also encouraged. CFAR-CFAR collaboration is especially encouraged to expand the range of influence. The following research areas are of special interest to the NIH.
• Operations research to implement existing and new HIV prevention interventions, therapeutic tools, and other care interventions for broad-based use, and the study of barriers to their integration and implementation.
• Collaborations involving training, research and research-related activities that focus on the protection of human subjects.
• Area 2: Behavior. Collaborative studies to develop behavioral interventions in AIDS clinical treatment settings
• Development of innovative approaches to risk behavior change based in HIV/AIDS treatment settings. Interventions of special interest are those that screen for HIV transmission risk behaviors; provide brief behavioral risk reduction interventions and examine optimal mechanisms for referral to services for prevention needs that are not feasible in medical settings; interventions that combine behavioral and medical/ biological components; and those that facilitate disclosure of serostatus to partner(s), combined with counseling.
• Studies of the associations, through all phases of illness and treatment, among HIV/AIDS treatment response, treatment adherence, risk behavior, and other psychosocial factors that are likely to impact these variables (e.g., housing instability, substance abuse, depression, domestic violence).
• Studies to identify the social and behavioral factors affecting recruitment, retention, and adherence to prevention and treatment interventions, including clinical trials of HIV-related vaccines, microbicides, and therapeutics are encouraged.
• Collaborative research on adherence to treatment regimens, including communication techniques to improve shared decision making between health care providers and HIV-infected individuals, on issues such as how and when to initiate therapy, how and when to begin interventions to assist with treatment adherence, and behavioral strategies to manage symptoms secondary to treatment protocols.
• Area 3: Substance abuse. Collaborative studies to understand the implications of substance-abuse and co-infections in AIDS pathogenesis, therapeutic, vaccine, and behavioral studies.
• Collaborative research on the optimal therapeutic approaches to HIV disease treatment and management, including treatment and management for both infectious and non-infectious conditions common among drug users (such as the bi-directional effects of HBV and HCV infection and their impact on treatment)
• Collaborative research on treatment interactions among commonly used HIV treatments, treatments for co-infections, and other pharmacotherapies, including drug abuse treatment medications, commonly prescribed for drug users
• Collaborative research on the impact of participation in therapeutic, vaccine and behavioral interventions on health and risk behaviors and on changing risk profiles among drug users
• Area 4: CAM. Collaborative studies on the effects of complementary and alternative medicine (CAM) on HIV infection, AIDS, and co-morbid conditions in the presence or absence of more conventional ART.
• Collaborative studies to identify the virological, immunological, and behavioral consequences of CAM treatment in the presence or absence of ART.
• Collaborative studies to determine the role of CAM in HIV/AIDS patients regarding quality of life outcomes, development of opportunistic infections and AIDS malignancies, and identification of new biological markers for disease progression.
• Area 5: Malignancies. Collaborations to elucidate the natural history and pathobiology of HIV-related malignancies in diverse populations across the spectrum of age and gender in national and international settings.
• Identify the mechanisms by which immune dysfunction, oncogenes, suppressor genes, carcinogens, HIV genes, and non-HIV viral and other microbial genes and proteins contribute to the development, progression, or maintenance of HIV-associated malignancies
• Correlate etiologic or molecular factors associated with development and/or progression of cancer in HIV+/AIDS with epidemiologic studies.
• Establish collaborations to identify novel mechanisms or targets suitable for translation to treatment and prevention modalities for these cancers.
• Area 6: Women/girls. Collaborative studies in women and girls, domestically and internationally, to elucidate the role of sex and gender in therapy and prevention.
• Studies in AIDS pathogenesis including the biology of HIV infection, progression to disease, and development and course of clinical manifestations associated with HIV infection, therapeutic interventions, co-infections, and concomitant conditions among women and girls.
• Collaborative studies to address the gender-specific, psychological, behavioral, social, environmental, economic, and cultural dynamics that increase or decrease risk for, and protection from, HIV transmission, acquisition, and disease progression among women and girls.
• Collaborative research to inform the diagnosis, care, and treatment of HIV-infected women and girls across the life cycle, including clinical studies of therapeutic interventions.
• Collaborative prevention studies to develop, test, and evaluate safe and effective technologies and products, including vaccines and chemical and physical barrier methods that are appropriate, acceptable, and accessible to women and girls, for preventing transmission and acquisition of HIV.

The CFAR Program at the National Institutes of Health (NIH) will also accept applications from current CFARs for a competitive supplement for training of developing world investigators. A single application from each site is permitted. However, collaboration between CFAR sites is strongly encouraged. One award of not more than $200,000 in direct costs will be made for one year.

• Area 7: Database training. Collaborative training program for developing world investigators to develop, maintain, and utilize clinical databases for AIDS studies.
• A collaborative training effort to develop a sustainable core of developing world AIDS investigators who will be knowledgeable in the maintenance and utilization of a clinical database that includes planned training of colleagues.
• Training should include technical issues relevant to database expansion and maintenance that includes, but is not limited to data dictionary design.
• Training should include expertise in human subject research considerations in database development such as human subject protection, consent form development, NIH OHRP required project assurance, and IRB requirements, both domestic and foreign.
• The proposal should include collaboration between an existing NIH-supported AIDS clinical database and existing or developing international AIDS clinical databases.

This funding will provide an opportunity for CFAR grantees to supplement activities in these under-studied and important areas of AIDS research through the developmental core. These efforts should complement existing research being undertaken by the CFAR institution. Support is designed to jump-start studies in these areas to assist investigators in the development of preliminary data, or begin a program, that can lead to long-term funding by standard research funding mechanisms, such as R21, R01, P01, etc. CFARs are strongly encouraged to identify areas appropriate for CFAR-CFAR collaborative efforts that will utilize the strengths of each site. Investigators are strongly encouraged to use existing cohorts such as The Multicenter AIDS Cohort Study (MACS) http://www.statepi.jhsph.edu/macs/macs.html, The Women's Interagency HIV Study (WIHS) https://statepiaps.jhsph.edu/wihs/, and the AIDS and Cancer Specimen Resource http://acsr.ucsf.edu. Studies that are an expansion or replication of CFAR supplements funded in FY2004 are not eligible.

The FY 2005 NIH Plan for HIV-Related Research, available at http://www.nih.gov/od/oar/updates/updates.htm, describes overall NIH HIV research priorities. Applicants are encouraged to review and consider these documents in preparing their applications.

ELIGIBILITY REQUIREMENTS

The grantee institution must be a currently funded CFAR institution that will have at least one year remaining in its current project period at the time of the supplement award, planned for August 1, 2005.

Each CFAR is limited to submitting a maximum of two applications for the scientific areas, and a single application for the training area. CFARs are encouraged to collaborate with other CFARs, especially in developing the training applications. Applications may include more than one scientific area of emphasis. Core and program groups within the CFAR institution are encouraged to collaborate on their applications.

FUNDING SUPPORT

Grants will be made as one year supplements. Awards are dependent upon the scientific merit of the applications and funding availability. Funding will be as a supplement to the developmental core with funds restricted for the funded study(s).

RESEARCH OBJECTIVES

The primary goal of this program is to build research capacity at the CFAR institution, and secondly, to expand studies that would benefit by CFAR-CFAR collaborations. This program is intended to complement ongoing domestic and International HIV/AIDS research efforts of the NIH and, in the case of international collaborations, to respond to the research priorities in the foreign country.

SPECIAL REQUIREMENTS

Applicants are requested to include: the background and rationale for the study; a description of the activities to be undertaken, and roles of key staff; expected outcome of these activities; expected follow-up plan upon completion of the supplement; a description of how the supplement and follow-up plan are expected to achieve this outcome (“value-added”); and plans to monitor and evaluate the ability of the activities to achieve the outcome.

Before any funds can be expended for in-country activities in a foreign country, the grantee institution must:

• Show evidence of approval from domestic (including collaborating US institutions), and foreign IRBs, documentation of human subjects training for all key personnel, evidence of OHRP required project assurance, and any required approval from the appropriate foreign government officials, per what is standard in that country. Additional information can be found at the OHRP website http://ohrp.osophs.dhhs.gov/.
• Further NIH-initiated administrative actions will need to be taken for international studies, and may be required for human subject research.

APPLICATION INSTRUCTIONS

A supplemental application will not be accepted until after the original application has been awarded, and the requested period of support may not extend beyond the term of the awarded grant.

Applicants are asked to submit, by December 10, 2004, supplement application(s) following the instructions for competing supplements in the PHS 398 with the following modifications:

Face Page:

• Item 1. Enter a descriptive title of the supplement application limited to 56 characters, including punctuation and spaces, just as for NIH grants
• Item 2. Enter PA-03-089 in the number box and CFAR Supplement and AIDS research priority areas in the title box. (Example: CFAR Supplement-Area1 or CFAR Supplement-Areas 1,2,5.)
• Item 3. Enter name of CFAR PI, not the name of the project director.
• Items 7 and 8. The requested budget should be modular.
• NO other support. This information will be required for all applications that will be funded. NIH will request complete and up to date “other support” information at an appropriate time after peer review.
• NO resource page (unless there are new resources that will be used for this study)
• NO appendices (except for glossies that have reproduced in the research plan)

Checklist:

• TYPE OF APPLICATION. Check SUPPLEMENT box and enter your CFAR grant number.

SUBMITTING AN APPLICATION

For applications in response to this supplement announcement the page limitation is 15 pages for the research plan, excluding letters of collaboration, the PHS398 form pages, checklist, budget and biosketches, literature cited, and human subjects or animal care and use information.

Submit a letter of collaboration endorsing the proposed study from each of the following participants: investigator performing the study and any collaborators, foreign investigator(s) (if applicable), foreign institution (if applicable).

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)

Two single-sided copies of the application (text) must be sent to:

Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service)

Applications must be received (not postmarked) by December 10, 2004. If an application is received after that date, it will be returned to the applicant without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the CFAR program officer for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to this announcement, the application will be returned without review.

Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by a peer review group convened by the NIAID in accordance with standard NIH peer review procedures. A selection process may be used in which only those applications deemed to have highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

REVIEW CRITERIA

The following criteria apply to all applications. Factors to be considered in the evaluation of each application include:

Significance – The effect that a collaborative competitive supplement would have on the overall AIDS effort at the institution(s).

1. Evidence that the proposed project(s) will enhance new multidisciplinary collaborations, that may include international collaboration, collaboration with industry, collaboration with junior or minority investigators, or collaboration with other CFAR sites.
2. The extent to which the supplement will address one or more of the priority areas identified in this request for supplement proposals (“value-added” of the supplemental monies)

Approach – The quality of the CFAR scientific project proposed, including planning, management, and training (as appropriate) process

3. Project design and appropriate core selection
4. Utilization or development of unique and appropriate expertise, technology, and resources at the CFAR institution(s), and at the international site, as appropriate
5. The adequacy of the described plans to monitor the impact of the competitive supplemental award.

Innovation - The identification of a unique project or approach to solve a significant question or gap in AIDS research

6. The degree of variety in AIDS scientific disciplines that are included in proposed scientific projects
7. The degree of innovation in project selection and experimental design

Investigator - Choice of appropriate scientists to lead the identification and development of the collaborative competitive supplement project

8. Choice of appropriate competitive supplement project leader and participating investigators for individual collaborative projects proposed: scientific qualifications, commitment, experience

Environment – The likelihood that the proposed project will achieve the stated goals

9. Availability of appropriate scientific expertise, and for training – availability of experience in database design, utilization, and training
10. The potential and intent to collaborate with other institutions and to coordinate program activities with related efforts of other CFARs, NIH programs, other federal agencies (e.g., CDC and USAID), international organizations (e.g., UNAIDS and PAHO), and NGOs (e.g., the International Union Against Tuberculosis and Lung Disease (IUATLD)
11. Previous history of support for developmental projects and outcomes, and for training, previous experience with database development, maintenance, and utilization in AIDS studies
12. Evidence that scientific collaborative areas and projects arise from the complementary scientific environment at the CFAR institution(s)

In addition, for applications involving international collaborations:

13. The demonstration of interest for international collaboration with scientists from developing countries, and emerging democracies, and institutions included in the proposed competitive supplement
14. The demonstration of continued or of future support for the program from governments, and either institutions or other non-governmental organizations from collaborating countries.

Reviewers will also examine the appropriateness of the budget, in consideration of the research environment, for the scientific/training projects and cores.

ALLOWABLE COSTS

Funding may be requested for any category normally funded by a CFAR grant that is required to fulfill the goals of the proposed study, and must be fully justified.

SCHEDULE FOR APPLICATIONS

AWARD CRITERIA

The following will be considered in making awards:

• quality of the proposed project as determined by the NIH convened peer review panel, and relevance to the research priority areas specified in this request;
• funding availability;
• program and geographic balance among the scientific areas.

INQUIRIES

Prospective applicants are strongly encouraged to discuss their applications, including proposed collaborating countries and institutions, with any member of the NIH CFAR Steering Committee (see below) before submitting formal applications. Investigators whose applications have a connection to any ongoing NIH programs are encouraged to discuss the proposal with the program officer representing that NIH Institute or Center. Contacts are listed below.

NIAID

Janet M. Young, Ph.D.
Program Officer
Basic Sciences Program
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4152
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 496-6714
FAX: (301) 402-3211
E-mail: jy6r@nih.gov

FIC

Jeanne McDermott, Ph.D.
Program Officer
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
FAX: (301) 402-0779
E-mail: mcdermoj@mail.nih.gov

NCI

Jodi B. Black, Ph.D.
Program Director
AIDS Malignancy Program
Division of Cancer Treatment and Diagnosis National Cancer Institute
Building 31, Room 3A44
31 Center Drive
Bethesda, MD 20892
Telephone: (301) 402-6293
FAX: (301) 496-0826
E-mail: jb377x@nih.gov

NCCAM

Morgan N. Jackson, M.D., M.P.H.
Director, Office of Special Populations
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Bethesda, MD 20817 (use for express/courier service)
Telephone: 301-402-1278
FAX: 301-480-3621
E-mail: mj145m@nih.gov

NHLBI

Liana Harvath, Ph.D.
Deputy Director, Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 10170
Bethesda, MD 20892-7950
Telephone: (301) 435-0063
FAX : (301) 480-0867
E-mail: HarvathL@nhlbi.nih.gov

NICHD

Pat Reichelderfer, Ph.D.
Microbiologist
Contraception and Reproductive Evaluation Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13
Rockville, MD 20852
Telephone: (301) 435-6991
FAX: (301) 480-1972
E-mail: pr20f@nih.gov

NIDA

Jag Khalsa
Health Scientist Administrator
Center on AIDS & Other Medical Consequences
National Institute on Drug Abuse
Neurosciences Center
Room 5198
6001 Executive Boulevard, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 443-1801
FAX: (301) 594-6556 or 443-4100
E-mail: Jk98p@nih.gov

NIMH

Dianne Rausch, Ph.D.
Deputy Director
Center for Mental Health Research on AIDS
National Institute of Mental Health
Neurosciences Center
Room 6209
6001 Executive Boulevard, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7281
FAX: (301) 443-9719
E-mail: dr89b@nih.gov

OAR

Fulvia Veronese, Ph.D.
Health Science Administrator
Office of AIDS Research
National Institutes of Health
Building 2, Room 4E16
31 Center Drive
Bethesda, MD 20892
Telephone: (301) 496-3677
FAX: (301) 496-4843
E-mail: fv10x@nih.gov

For questions concerning the peer review process, applicants may contact:

Dianne Tingley, Ph.D.
Chief, AIDS Preclinical Research Review Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 496-0818
FAX: (301) 480-2310
E-mail: dt15g@nih.gov

For questions concerning budget and fiscal matters, applicants may contact:

Lori Zimand
Grants Management Specialist
National Institute of Allergy and Infectious Diseases, NIH, DHHS
6700B Rockledge Drive, Room 2248
Bethesda, MD 20892 (express mail: 20817)
Telephone: 301-451-4580
Fax: 301-493-0597
E-mail: lz36k@nih.gov