HIV/AIDS AND DRUG USE AMONG ADOLESCENTS Release Date: January 29, 2001 RFA: RFA-DA-01-007 National Institute on Drug Abuse (http://www.nida.nih.gov/) Letter of Intent Receipt Date: February 28, 2001 Application Receipt Date: March 28, 2001 THIS REQUEST FOR APPLICATIONS (RFA) USES THE "MODULAR GRANT" AND "JUST-IN- TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The purpose of this RFA is to support drug-use/abuse focused HIV/AIDS studies that address the particular challenges and needs of HIV-infected and at-risk adolescents. Specifically, research applications are sought on: (a) prevention of HIV infection and related infectious diseases among adolescents, (b) transmission by HIV-positive youth, (c) accessibility, integration, and management of adolescent-specific medical, mental health, and drug treatment services and interventions relative to HIV infection, (d) outreach strategies for high-risk adolescent sub-populations, and (e) analysis of infectious comorbidities and their influences on HIV progression. This RFA is also meant to encourage appropriate research with pre- adolescents, such as strategies for early HIV prevention efforts in various settings (e.g., primary health care, community-based clinics, schools). HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This Request for Applications (RFA), "HIV/AIDS and Drug Use Among Adolescents," is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01) and exploratory/developmental (R21) (http://grants.nih.gov/grants/guide/pa-files/PA-99-089.html) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2001. FUNDS AVAILABLE The National Institute on Drug Abuse (NIDA) intends to commit approximately $1,500,000 in FY 2001 to fund three to six new and/or competitive continuation grants in response to this RFA. The total project period for an application submitted in response to this RFA may not exceed five years for the R01 and three years for the R21. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NIDA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background In contrast to attenuation of the infant AIDS epidemic in the United States, there is evidence that HIV infection rates are increasing in the adolescent population. This expanding adolescent HIV epidemic is increasingly female, minority, and related to sexual transmission (i.e., heterosexual activity in females and homosexual activity in males). Use of alcohol and illicit drugs by youth is related to early sexual experience. These risky behaviors may lead to unprotected sexual intercourse and are related to the acquisition and transmission of HIV among adolescents. Certain sub-populations of adolescents, in addition to females and minorities, are particularly at high risk for HIV infection. Examples are homeless, runaway, and street youth who engage in unsafe sex as a means of obtaining drugs or money, especially in urban areas with high HIV rates, adolescents in juvenile detention centers where there is frequent HIV-associated risk-taking behavior, and drug-using adolescents in rural communities with increasing HIV seroprevalence. Within the broad areas of HIV prevention, transmission, disease progression, consequences, and treatment, studies are greatly needed on specific concerns arising from the intersection of adolescence, drug abuse, and HIV/AIDS. Clinical care of HIV-infected adolescents involves unique challenges and management demands. The presence of drug use/abuse provides additional unique challenges. Information on the manifestations and progression of HIV disease in drug-using adolescents is critical to the further development and evaluation of an adolescent-specific therapeutic agenda. Recent data provide evidence that there are differences in the immune systems of male and female adolescents and that adolescents immune systems differ from those of children and adults. The long-term implications of these disparities, the immunologic potential of adolescents, the development of methods for enhancing adolescents HIV specific immune responses, and complications of these processes related to drug abuse need further study. HIV-infected adolescents must face the common challenges associated with normal pubertal development, as well as the acceptance of chronic illness, complex drug regimens, and disclosure of condition to peers. Adolescents often have difficulty with chronic, complicated therapeutic regimens initiated during this period. There is need for adolescent-specific studies aimed at improving treatment adherence and preventing or minimizing the negative physical, psychological, cognitive, and social consequences of HIV infection during adolescence, for youth in general, and for drug- using/abusing youth in particular. Areas of Interest To advance the current knowledge base about HIV/AIDS and drug abuse in adolescent populations, this RFA solicits applications covering a broad range of specific research topics. To the extent possible and appropriate, investigators are encouraged to incorporate consideration of gender differences in their research designs and analyses. The following are illustrative examples of research that would be responsive to this RFA. They are intended as a guide and not meant to limit the themes or approaches that could be proposed. o Measurement of incidence and prevalence of HIV infection and related infectious diseases among drug-abusing adolescents. o Development, evaluation, and dissemination of prevention strategies to reduce the incidence of drug-use related HIV infection, including: - study of community-based behavioral and social intervention strategies to reduce needle-sharing and high-risk sexual behavior among injection drug users, crack cocaine users, and their sexual partners, - approaches targeting youth at high risk for initiating injection drug use and/or initiating sexual risk behaviors associated with drug use, - primary prevention programs that include both HIV and drug abuse prevention (especially the integration of HIV risk components with existing drug abuse prevention programs), - joint drug abuse and HIV prevention programs for high-risk groups, such as gay/bisexual males, heterosexual females, minorities, street youth, and adolescents in continuation high schools and juvenile detention, and - prevention programs for underserved populations (e.g., Native American, African American, rural, etc.). o Outreach strategies for high-risk adolescent sub-populations. O Development of methods and screening procedures for use by healthcare providers to identify youth at risk of future exposure to HIV infection, particularly those in elementary and middle schools. o Impact of public policy on prevention and treatment of HIV infection among adolescents. o Impact of use of illicit drugs on the effectiveness of HIV therapy. o Evaluation of the complications of HIV therapy during adolescent maturation, such as metabolic (including nutritional), endocrine, and cardiovascular disorders, drug-drug interactions, and hepatotoxicity, relative to substance abuse, other pharmacotherapies, and co-infections, such as hepatitis C. o Improvement of access to and utilization of health services by drug-using HIV-infected adolescents, including strategies to: - improve adherence with HIV medications, - recruit and retain participants in HIV/AIDS treatment, and - deliver linked medical and drug abuse treatment services. o Organization and management of services for HIV-positive adolescent drug abusers, including analyses of barriers to services and access and utilization, and strategies to overcome them (e.g., mobile vans as a means for improving health care access by drug abusers). o Cost, cost-benefit, and cost-effectiveness of interventions to reduce HIV risk behaviors and prevent the transmission of HIV among adolescents. o Development of interventions to support transitions from pediatric to adolescent and from adolescent to adult health care settings. o Factors that may make adolescents more vulnerable to HIV infection (e.g., hormonal contraceptives, prevalence of STDs), and how use of illicit drugs may influence such vulnerability. o Adolescent-specific disease progression in drug-using youth, including: - effects of puberty-associated hormonal levels on HIV progression, - gender differences in pathways to and progression of HIV-infection among adolescents, and - adolescent-specific immune responses to HIV infection and drug abuse, including reproductive immaturity and hormonal changes. o Relationships between ongoing drug use, health, mental health, and development of HIV-positive youth. o Assessment of infectious comorbidities (e.g., viral hepatitis) and their influences on HIV progression. o Effects of HIV infection and disease progression on drug use patterns and the resulting influence of drug use on morbidity. o Behavioral and psychosocial consequences of HIV diagnosis during the critical developmental period of adolescence (e.g., drug use, risky sexual behavior, depression). o Special issues in rural and international settings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA"s Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE Researchers funded by NIDA who are conducting research in community outreach settings, clinics, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection include injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of all other personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. Send the letter of intent (by receipt date listed in the heading of this RFA) to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form, and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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) At the time of submission, two additional copies of the application must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data. Schedule Letter of Intent Receipt Date: February 28, 2001 Application Receipt Date: March 28, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 30, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include scientific merit (as determined by peer review), availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jessica Campbell, Ph.D. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-0854 FAX: (301) 443-4100 Email: jcampbel@nida.nih.gov Direct inquiries regarding review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 E-mail: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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