This Program Announcement expires on June 1, 2004, unless reissued. HIV TREATMENT ADHERENCE RESEARCH Release Date: March 20, 2001 PA NUMBER: PA-01-073 (The R01 portion has been reissued as PA-07-338, the R03 as PA-07-339, the R21 as PA-07-340 and R34 as PAR-07-341) National Institute of Mental Health ( National Institute of Drug Abuse ( National Institute of Alcohol Abuse and Alcoholism ( THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. THIS PROGRAM ANNOUNCEMENT REPLACES PA-97-070 PURPOSE The efficacy of combination antiretroviral medication therapies (ART) for the treatment of HIV-disease is now well documented. Combination therapies can inhibit viral replication and reduce viral load to a point where viral particles are undetectable in the blood of infected individuals. Significant and sustained suppression of HIV replication is associated with improved clinical outcomes. However, these benefits are only tenable when adherence to precise dosing schedules is rigorous and other treatment requirements are closely followed. Partial or poor adherence can lead to the resumption of rapid viral replication, poorer survival rates, and the mutation to treatment-resistant strains of HIV. Both domestically and internationally, behaviorally based interventions will continue to be integral to the success of any medication advances and their health outcomes. Therefore, understanding and enhancement of ART treatment adherence remains a critical goal for the individuals receiving treatment, for those providing treatment, for public and private health officials who are responsible for making treatment available, and for the public health at-large. In response to this pressing need, scientists and practitioners have made significant gains in ART adherence research. For example, progress has been made to simplify dosing regimens, to ameliorate aversive medication side effects, to improve access to health care, to facilitate behavior changes to avoid re- infection with HIV or other STDs, and to intervene with consumer and provider characteristics (e.g., increase self-efficacy, remove barriers to adherence, treat psychosocial factors that can impair adherence), in order to advance treatment adherence to an acceptable level. However, as the HIV pandemic and treatment rapidly evolves, the goals of ART adherence research must also evolve to build on scientific advances and the changing needs of those affected by HIV. This Program Announcement (PA) identifies gaps in the understanding of ART adherence, and encourages studies to address the role of adherence through all phases of treatment and illness, the need to broaden the scope of interventions to enhance treatment adherence, and the importance of tailoring methodological and intervention advances to the special needs and context of affected populations. Emphasis is on the development of innovative approaches to adherence and behavior change, especially models of interventions to improve adherence. Approaches based on basic behavioral principles such as cognition, emotion, decision-making, motivation, social interaction, and cultural context are particularly encouraged. A well-articulated and empirically based conceptual framework is essential in applications solicited under this announcement. 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 PA, HIV TREATMENT ADHERENCE RESEARCH, is related to one or more of the priority areas of the NIH Strategic Plan for HIV-Related Research, i.e., to improve treatment adherence and quality of life among infected individuals. Potential applicants may obtain a copy of "Healthy People 2010" at: 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. Foreign institutions may apply for the R01 mechanism, but are not eligible for small grants (R03). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and small grant (R03) mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years for the R01 award, and 2 years for the R03. Special instructions and information for the Small Grant (R03) mechanism, generally applicable to NIMH, NIAAA, and NIDA, are available in the NIH Guide for Grants and Contracts at: Because small grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with NIMH, NIAAA, or NIDA program staff (See INQUIRIES). R03s are limited to 2 years of support at a maximum of $50,000 direct costs per year, and are not renewable thereafter. For all competing applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. RESEARCH OBJECTIVES Background The efficacy of combination therapy with antiretroviral drugs (ART) has dramatically altered the landscape of HIV treatment. Treatment with protease inhibitors and other antiretroviral drugs can inhibit virus replication and reduce virus load to undetectable levels. Significant and sustained suppression of HIV replication is associated with improved clinical outcomes. However, benefits of combination medication regimens require careful adherence to precise dosing schedules and other dosing requirements. Poor treatment adherence can allow the virus to resume its characteristic rapid replication, providing the opportunity to generate resistant mutant strains no longer responsive to available antiretroviral drugs. Widespread transmission of resistant HIV strains is becoming an increasingly serious public health concern in the United States and throughout the world. There has been a widespread response to the need for adherence studies. More than 150 abstracts on this topic were presented at the 12th International AIDS meeting in Geneva in 1999, and findings are being presented with greater frequency in peer-reviewed journals. This literature, combined with prior theory and research on other chronic disease conditions (e.g., diabetes), has informed good working models for HIV treatment adherence. In general, understanding of adherence has focused on the individual or the consumer. For example, depressive symptomatology and substance abuse problems are often associated with poor ART adherence. However, despite a growing body of evidence regarding the influence of mental health factors on adherence (e.g., severe mental illnesses, substance abuse, high stress levels), only about 40 percent of HIV treatment locations offer on-site mental health treatment, and fewer offer drug or alcohol treatment. Innovative, effective interventions are needed to facilitate behavior change, improve ART adherence, and prevent treatment relapse among persons at high risk for acquiring and transmitting the infection, including the severely mentally ill and both injecting and non-injecting drug users. Although persons with severe mental illness are at enhanced risk for HIV, very little is known about their ART adherence and such issues as interactions of ART medications with psychoactive medications. Relatively few ART adherence studies have addressed the provider or system level, which includes integrated service delivery, staff training, economic and sociocultural barriers, or other structural factors that affect access and adherence to ART. Investigators should attempt to broaden the scope of interventions to enhance treatment adherence. For example, there is evidence that treatment providers may make decisions about when and with whom to start utilizing ART methods (to assess a consumer’s likelihood of adequate adherence) without being fully aware of reliability and validity issues. Assessment tools are available, but translational studies are needed to illuminate how best to implement research findings for provider use. Regarding provider/consumer relationships, a better understanding is needed regarding how effective alliances are facilitated among providers, consumers, and their family and/or friends. More needs to be known about what basic behavioral principles foster these alliances or partnerships, with the aims of improving the process, effective treatment, and outcomes of HIV disease. Studies are needed to better understand the antecedents and correlates of adherence throughout the phases of treatment and disease. Adherence related factors are not expected to be similar across disease stages. Pre-ART interventions may, for example, address different mechanisms than interventions coincident with ART initiation and maintenance. Very different issues are likely to be important with individuals who have been on ART for years. For many, HIV disease has become more of a chronic condition and other lifestyle concerns may become more immediate and important (e.g., employment, medical care, day-to-day stressors, dyadic and sexual relationships, complacency about infectivity, drug and alcohol use). Understanding the effects and interactions of these and other behavioral, social, and environmental factors on an individual’s attitudes, beliefs, and motivations toward ART adherence will help in the development of improved interventions for ART adherence across the stages of HIV infection and disease. Research issues related to directly observed therapy (DOT) highlight the importance of environmental factors and their effects on adherence. A few studies have shown that DOT results in better adherence and treatment outcomes. However, little is known about the effectiveness of this treatment strategy when individuals make environmental transitions (e.g., change their living arrangements), when medical condition improves or worsens, or when the treatment regimen changes. For example, DOT has been used successfully in correctional settings with HIV-positive inmates, but researchers have rarely followed participants longitudinally upon return to the community to evaluate how, whether, and for how long these individuals connect to post-incarceration services and adhere to ART without DOT. Similar issues arise in the transition of consumers from inpatient to outpatient care, when individuals move to different housing, geographic location, or to new treatment providers. Qualitative findings also suggest that not all non-adherence is unintentional. Some investigators have begun to examine the effects of scheduled periods of drug holidays ( intermittent ART ). Even short drug holidays have been linked to rapid viral rebound, but the evidence is less clear regarding a loss in general immune response or the development of drug resistance. Cyclic use of ART is desirable for many HIV-infected persons who want periods of being drug free, however, more research is needed to understand the risks and consequences of episodic adherence or on the development of HIV resistant strains. In addition, little is known about characteristics that may contribute to adherence or non-adherence decision-making, such as personality traits, attitudes, stigma, and self-esteem. Moreover, as secondary HIV prevention (prevention targeting those already living with HIV) becomes more of a national and international priority, it is important to understand how adherence to medication regimens is correlated with adherence to other health risk behavior practices, such as practicing safer sex or harmful alcohol or drug abuse. In summary, understanding the factors influencing adherence and development of effective interventions are critical for improved clinical outcomes among persons on ART. Access to health care and difficulties in managing and sustaining complex treatment regimens for HIV are challenges for many who are hard to reach and underserved, as well as for providers. For example, engagement of drug abusers into HIV care through accessible programs, such as primary care linked with methadone treatment, has demonstrated reduced morbidity and improved survival, nevertheless, providers may consider drug abusers as high risk candidates for ART. Because there has been an under-representation of hard to reach individuals, such as drug abusers and persons with comorbid conditions, in clinical studies of HIV therapies, there are few data on potential risks of drug interactions and toxicity in these populations. For example, interactions between illicit drugs and HIV therapies, as well as pharmacotherapies for substance abuse, mental health conditions, and other diseases, may cause morbidity, influence adherence, and reduce the effectiveness of HIV treatment. Appropriate sample selection is especially critical in these areas, because it is important that the field does not advance with an understanding only of adherence among study participants who may already tend to be more adherent. The ability to draw generalizations from study findings and the power to detect post-intervention changes will be limited without attention to this issue. That is, some of the factors that may be related to poor adherence to medication and appointments (i.e., language barriers, difficulties accessing medical care, childcare needs, substance use, fear of stigmatization, and a host of other contextual factors) may also be barriers to research participation. This PA seeks a broad range of research on HIV treatment adherence, including but not limited to the following: o Research on the relationship(s) among disease stage, individual difference characteristics, treatment response, and adherence is related to treatment outcomes throughout the course of the treatment, illness, and intervention(s), identify points where different types of adherence interventions can have the greatest impact o Research to expand understanding of the mechanisms by which factors associated with adherence and non-adherence, such as depression and substance use, influences adherence related behavior, risk studies of the factors underlying individuals" decisions to adhere or not to adhere should link directly to development and testing of interventions to modify those mechanisms o Research on treatment provider-caregiver-consumer alliances, how these interrelationships affect adherence to complicated medication regimens, and identification of the active ingredients of effective alliances o Studies of beneficial and deleterious behavior risk changes that occur as a result of HIV therapy and of the factors that influence long-term therapeutic effectiveness, development of viral resistance, disease progression, and medical outcomes in high-risk individuals o Research to improve the effectiveness of staff training in consumer education to promote adherence o Studies to develop, adapt, and assess theory-based interventions for improving adherence among underserved, high risk, or special need populations (e.g., persons with severe mental illness, incarcerated individuals, active drug and alcohol users, adolescents) o Research to understand how integrated service delivery systems contribute to effective consumer adherence, especially when environmental transitions are addressed o Studies on the effectiveness, toxicities, and pharmacologic interactions of antiretrovirals with drug abuse treatment medications for drug abusers, ongoing illicit drug abuse, and pharmacotherapeutic medications for dually-diagnosed individuals o Research to refine measurement of ART adherence (e.g., studies that account for the myriad of biological and health behavioral that can influence CD4 count and viral load, in the context of treatment and adherence interventions, to identify appropriate intervention outcomes) o Research on the effectiveness of improving adherence through consumer education using a variety of health-related informational modules, a variety of modalities (including groups involving families, friends, significant others), repetition of information, and follow-up educational sessions, computers, etc. o Research on economic and other structural barriers or facilitators to ART, and studies of the relationships between these factors and adherence in the context of other competing demands o Studies of how factors underlying adherence or behavior change in other chronic diseases might inform adherence to ART 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 (, a complete copy of the updated Guidelines are available at: 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: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits 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: Applications are also available on the World Wide Web at: SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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. 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 for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o 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 the 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 key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - 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. o 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 title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and 5 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIH in accordance with the standard NIH peer review procedures. 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Christopher M. Gordon, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6199, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-1613 FAX: (301) 443-9719 E-Mail: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 E-Mail: Elizabeth Lambert, M.Sc. 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) 402-1933 FAX: (301) 443-4100 E-Mail: Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 E-Mail: 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) 594-6849 E-Mail: Linda Hilley Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 E-Mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.279 (NIDA), and 93.273 (NIAAA). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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 and contract 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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