Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)

Title: HIV and Drug Abuse Interventions among Pregnant Women in Drug Abuse Treatment

Announcement Type
New

Request For Applications (RFA) Number: RFA-DA-05-008

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: January 21, 2005
Letters of Intent Receipt Date(s): 02/21/2005
Application Receipt Date(s): 03/21/2005
Peer Review Date(s): 06/2005
Council Review Date(s): 09/2005
Earliest Anticipated Start Date: 09/2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: 03/22/2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This RFA invites applications for studies testing interventions to prevent or reduce HIV risk among pregnant women in drug abuse treatment through: 1) targeted behavioral HIV prevention and risk reduction interventions; and 2) behavioral interventions aimed at improving adherence to prenatal care regimens among HIV-positive, pregnant drug-abusers. A total of $1.5 million is anticipated for funding approximately 4-6 meritorious research projects. The grant mechanisms eligible for funding through this RFA are the small grant (R03), the exploratory/developmental grant (R21), and the standard research grant (R01) mechanisms. Eligible institutions include for-profit, non-profit, domestic, foreign, public, private, and certain units of state and local government also faith and community based, eligible Federal. Eligible principal investigators are any applicants with the skills, knowledge, and resources to carry out the proposed research. An applicant may not submit more than one application in response to this RFA for which he or she is the Principal Investigator or Co-Investigator. An applicant who is the Principal Investigator on one application may serve as a consultant on other applications submitted in response to this RFA. Application materials are available through the NIH website (http://grants.nih.gov/grants/forms.htm), and technical assistance in preparing applications is available from the contact people listed in this announcement. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description


Purpose of the RFA

The purpose of this Request for Applications (RFA) is to encourage research on HIV prevention and risk reduction interventions among pregnant women in drug abuse treatment. (For the purposes of this RFA, drug abuse treatment refers to behavioral or combined behavioral and pharmacological treatment of drug abuse and/or dependence.) Pregnancy is a time of increased risk for HIV infection, both for drug-using women and for their infants through mother-to-child transmission. Behavioral HIV prevention and risk reduction interventions have shown promise in reducing HIV risk behaviors with a wide variety of drug-using populations, including drug-abusing pregnant women. For HIV-infected pregnant women, evidence suggests that proper HIV intervention care, including the use of certain antiretroviral medications, can reduce the maternal transmission of HIV to the child and can reduce other maternal and fetal complications. This RFA invites applications for studies to prevent or reduce HIV risk among pregnant women in drug abuse treatment through: 1) targeted behavioral HIV prevention and risk reduction interventions; and 2) behavioral interventions aimed at improving adherence to prenatal care among HIV-positive, pregnant drug-abusers.

Background

National surveys indicate that drug use and associated HIV risk during pregnancy is a major public health concern. The most recent National Survey on Drug Use and Health (SAMHSA, 2004) reported that among pregnant women aged 15 to 44 years, 4.3 percent reported using illicit drugs in the month prior to their interview. In the National Pregnancy and Health Survey, 4 million women who gave birth in the years 1992 and 1993 were surveyed in the hospital about drug use and other health behaviors (NIDA, 1993). Results of the survey indicated that approximately 21% (820,000) of women smoked tobacco during their pregnancies, 20% (757,000) used alcohol, and 6% (221,000) used at least one illicit drug. Marijuana and cocaine were the most frequently used illicit drugs, with 119,000 and 45,000 reporting use of these drugs during their pregnancies, respectively. Use of multiple drugs was common, with 32% of those who reported use of illicit drugs during pregnancy also using cigarettes and alcohol.

The key risk behaviors for contracting HIV are engaging in risky sexual behaviors and using non-sterile drug-injection equipment. Pregnant drug abusers appear to be at equal or increased risk for engaging in these behaviors, as are other drug abusers. For instance, in a study comparing pregnant and non-pregnant women at high risk for contracting HIV, in which women were either intravenous drug users themselves, or were sexual partners of intravenous drug users, pregnant women were significantly less likely to use condoms than were non-pregnant women (Deren et al., 1993). In addition, although intravenous drug use was less prevalent among pregnant women than among non-pregnant women, needle-related risk behaviors were equivalent among participants who abused drugs by injecting. Another study found that pregnant, injection-drug users in methadone maintenance treatment had higher injecting risk-taking behavior than did non-pregnant women in treatment, and had similar injecting risk-taking as non-pregnant, out-of-treatment women (Baker et al., 2001).

In addition to the HIV-related risks associated with drug use in general, drug use during pregnancy carries with it further HIV-related consequences related to poorer prenatal care and infant outcomes. There are multiple adverse consequences of maternal drug use on the developing fetus for use of alcohol, cocaine, marijuana (Kaltenbach & Finnegan, 1997), and opioids (Kaltenbach et al., 1998), including premature labor and neonatal abstinence syndrome. In a study comparing women using cocaine during pregnancy to those not using cocaine, both maternal and fetal complications were significantly higher among cocaine-using women (Burkett et al., 1998). Among the complications associated with cocaine use during pregnancy were maternal HIV seroconversion, syphilis, and anemia, as well as premature birth and low birthweight. A recent multisite, prospective study found similar adverse consequences of maternal drug use, although the prevalence of risk outcomes was lower than previous reports (Bauer et al., 2002).

Among HIV-positive pregnant women, prevention of transmission of HIV to the infant is a key component of perinatal care. Preventive efforts typically include prenatal HIV counseling and testing, antiretroviral prophylaxis, elective cesarean delivery, and avoidance of breast feeding (Mofenson et al., 2000), with best practices yielding mother-to-infant transmission rates below 2%. Similar to pregnant women without HIV infection, drug use among HIV-positive pregnant women is significantly associated with a lack of prenatal care, and with the related increases in HIV-infected infants. For instance, in a study by the Centers for Disease Control and Prevention, data were collected on 4755 infants born to HIV-infected mothers between 1996 and 2000 based on medical record reviews. Illicit drug use among the mothers was significantly associated with lack of prenatal care, with 17% of illicit drug-using women receiving no prenatal care versus 3% of women with no reported drug use (Peters et al., 2003). Based on significant multivariate associations between the rates of mother-to-infant HIV transmission and the patterns of prenatal care, the researchers concluded that more than half of the cases of HIV infection in infants could be attributed to missed opportunities for prenatal HIV prevention. Studies that develop and test interventions to improve prenatal care among HIV-positive pregnant drug abusers would contribute greatly to the reduction of HIV risk in a highly vulnerable population.

Populations vulnerable for health disparities in other areas of health--such as ethnic and racial minorities, those with fewer economic or social resources, and those managing multiple psychosocial problems--seem to be particularly vulnerable to drug use and related HIV risk during pregnancy. Several studies have reported that drug use is higher and treatment outcomes are poorer for pregnant women with fewer economic and social resources and more psychiatric problems (Comfort & Kaltenbach, 2000; NIDA, 1993). A study of pregnant women in Jamaica found that women of low-income attending a public hospital were at equivalent risk as a group of substance abusers for HIV seroconversion during the 5-year study period from 1996 to 2001, while there were no seropositive women among those receiving care at private medical clinics (Wynter et al., 2003). Among pregnant drug abusers entering a comprehensive treatment program, being a victim of partner violence (Tuten et al., 2004), or being homeless (Tuten et al., 2003) is related to greater drug use, and higher rates of social problems and psychiatric disorders, including higher rates of suicidal ideation and medical problems. Importantly, women experiencing partner abuse also had partners with greater rates of alcohol and illicit drug use, putting these women at greater risk for HIV through partner-related sexual risk and drug risk behaviors.

Regarding ethnicity, studies show fairly consistently that African American and Hispanic women tend to experience increased risk and poorer outcomes with regard to HIV, although these outcomes almost certainly have multiple determinants. For example, in a national study of 891 pregnant, HIV-positive women, Caucasian women had significantly better viral suppression at the time of delivery than did Hispanic or African-American women. While there were no significant differences by ethnicity in the initiation of prenatal care, there were significant differences in initiation of maternal HIV testing and treatment before pregnancy, with Caucasian women (42%) more likely than Hispanic (29%) or African-American (27%) women to initiate antiretroviral therapy prior to becoming pregnant (Cunningham et al, 2004). In another study conducted in California, children born to Latina and African-American women accounted for the majority of the State's pediatric AIDS cases diagnosed between 1998 and 2001 (Ruiz et al., 2002).

Somewhat paradoxically, perceptions of being at low risk for HIV may also increase vulnerability to HIV risk and inadequate screening and intervention. A survey on HIV screening and risk counseling practices was administered by the American Academy of Pediatrics (AAP) Committee on Pediatric AIDS to a random sample of the AAP membership (Kline et al., 2003). While more than three-fourths of the approximately 988 pediatrician-respondents reported that HIV screening during pregnancy or postpartum should not be limited to women with perceived risk for infection, HIV screening practices appeared related to pediatricians' perceptions of the likelihood of HIV risk. Pediatricians reported discussing a maternal or newborn HIV screening test with only about 10% of mothers for whom the HIV status was unknown. Among the reasons given for not discussing HIV screening with mothers were a low prevalence rate in the practice area (reported by 65.4% of respondents), a judgment by the pediatrician that the parents did not fit the profile of those “at risk” for HIV infection (reported by 56.1%), and a fear of offending the parents (reported by 50.2%). Another recent finding from a study of a couple's treatment for substance abuse suggests that even spouses in relatively stable relationships can be at high risk for HIV (Fals-Stewart et al., 2003). This study found that wives of men in substance abuse treatment unknowingly were at increased risk for HIV infection because of their husbands' engaging in risky behaviors, and because of couples' irregular use of condoms during intercourse. Taken together, these studies suggest that the need for HIV prevention and risk reduction interventions is not unique to traditionally vulnerable populations.

Theories of behavior change that emphasize rational decision-making, outcome expectancies, motivation, etc. (e.g., Fishbein's theory of reasoned action and Prochaska's transtheoretical model of change) might predict that pregnancy would be a critical window of opportunity for HIV intervention, increasing women's attention to health behaviors and motivation to seek drug abuse treatment. While there are no published studies that address these issues directly for pregnant drug abusers, the few that have tangential relevance do not support these predictions, suggesting that the clinical picture may be more complex. For instance, a study comparing pregnant and non-pregnant drug-abusers in methadone maintenance treatment between 1994 and 2003 found that women did not differ significantly on severity of addiction at treatment intake, on retention rates throughout treatment, or on urinalysis measures of treatment outcome (Crandall et al., 2004). In the Deren et al. study (1993), although intravenous drug use was less prevalent among pregnant women than among non-pregnant women, pregnancy did not appear to affect needle-related risk behaviors among participants who abused drugs by injecting. More research is needed to maximize the effectiveness of interventions to reduce HIV risk among drug abusers during pregnancy.

The research evidence, including an NIH consensus conference in 1997 and several published literature reviews, presents strong convergent evidence that drug abuse treatment can be an effective HIV prevention and risk reduction intervention. The most recent literature review found evidence that drug abuse treatment significantly reduces HIV risk behavior using three indicators: comparing drug abusers on HIV risk behaviors before and after drug treatment; comparing drug abusers in treatment to their matched out-of-treatment controls; and comparing rates of HIV seroconversion for those in continuous treatment versus those with no or incomplete treatment (Sorenson & Copeland, 2000). Earlier reviews reported similar findings (Des Jarlais et al., 1990; Metzger et al., 1998). The limitations in the existing drug treatment literature present opportunities to improve HIV prevention and risk reduction interventions in future research. Among the limitations cited by multiple researchers are the high drop-out rates in the treatment samples, the over-reliance on self-report measures of risky behaviors, and the relatively low efficacy in changing sexual risk behaviors compared to changing drug-related risk behaviors. Also, the majority of the drug abuse treatment studies in these reviews were methadone maintenance treatments, so that less is known about the role of other treatments in HIV prevention and risk reduction. This RFA calls for research to address the limitations of the current literature, including developing and testing more reliable measures of risk behaviors, and studies targeting sexual risk as well as risk related to drug use behavior itself.

Also, pregnant substance abusers may benefit from tailored HIV risk reduction interventions, with special attention to the social relationships of these women. Research suggests that the male partner is of great importance to the recovery status of pregnant substance-abusing women. Pregnant women with a drug-using partner have been found to be 5 times more likely to use drugs themselves (Bresnahan et al., 1992) than pregnant women with a drug-free partner. One treatment study suggests that pregnant women with drug-free partners feel more supported in their recovery and stay in treatment longer than do women with drug-using partners (Tuten & Jones, 2003). This study also found that intervening with the drug-using male partners of pregnant women in treatment improved drug outcomes for both male partners and pregnant women in treatment. Relatedly, the 1997 NIH Consensus Conference recommended that HIV prevention interventions for women take into account potential power differences in their relationships with men. Power and potentially related issues such as abuse and partner violence may be especially relevant issues during pregnancy, when women may have increased dependence on their male partners for physical and financial well-being.

Given the importance of prenatal care and attention to HIV prevention, especially for HIV-positive pregnant women, interventions to improve adherence to prenatal regimens are needed. Despite fairly universal recommendations for preventive HIV treatment among HIV-positive pregnant women, adherence to HIV treatment regimens during pregnancy is relatively low for some populations. One study of HIV-positive pregnant women at public clinics found an average adherence to zidovudine (AZT) in the last 3 weeks of pregnancy of 50% (defined as doses per day taken/prescribed), declining significantly to 34.1% by 3 weeks postpartum (Ickovics et al., 2002). Another study found that use of prophylactic AZT during pregnancy was related to the type of prenatal care women received, and to the 1994 US Task Force Recommendations to use AZT during pregnancy to reduce transmission (Sambamoorthi et al., 2002). Based on AIDS/HIV surveillance data and Medicaid records in New Jersey between 1992 and 1996, women with no health care during pregnancy received no prophylactic AZT. About 27% of women with health care that was not pregnancy-specific used AZT after the 1994 recommendations were published. Even among women receiving pregnancy-specific health care from specialty providers, only 63% used AZT after the recommendations were published. Across all users of AZT, only 24% used for the 3 months prior to delivery, and African American women were less likely to be persistent AZT users, even after controlling for other factors. Other studies have reported on women's beliefs and concerns about taking AZT during pregnancy, including a fear of toxic effects on the baby, the belief that prophylaxis is not needed for asymptomatic HIV-positive women, a previous birth to a healthy baby without using AZT, and troublesome side effects (Siegel et al., 2001; Sowell et al., 2001). Studies to develop and test interventions to improve adherence to prenatal HIV prevention and risk reduction regimens are of high priority in the efforts to reduce the mother-to-infant transmission of HIV/AIDS.

1. Research Objectives

This RFA requests research developing and/or testing behavioral HIV prevention and risk reduction interventions for pregnant women in drug abuse treatment. Applicants are encouraged to follow the 3-stage model of intervention research used in behavioral treatment research at the National Institute on Drug Abuse. Stage I involves the development and pilot-testing of interventions based upon or translated from basic behavioral, cognitive, or clinical science and theory. Stage II involves efficacy-testing of promising interventions. Stage III involves testing efficacious interventions in the community, including controlled clinical trials to determine if an intervention maintains its efficacy when delivered by community therapists, counselors, or clinicians in community settings. Stage III also includes research addressing how to transport interventions to community clinicians, such as therapist training/supervision research. Integral to all three stages is a focus on mechanism of action— how an intervention works in addition to whether it works. This RFA calls for studies in all three stages, depending on the state of the science appropriate to the research question of interest. (For a more detailed description of the stage model of treatment research, please see the Behavioral Therapies Development Program Announcement, PA-03-126, http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html).

Examples of research studies relevant to this RFA include, but are not limited to, the following areas:

Studies testing standard HIV prevention or risk reduction interventions, along with tests of their mechanism of action (MOA), for use with pregnant substance abusers in drug abuse treatment.

Studies developing or testing tailored HIV prevention or HIV risk reduction, concurrently examining their MOA, in pregnant women in drug-abuse treatment, based on theoretical or empirical evidence that tailored interventions might be necessary.

Theory-based studies focusing on the development, testing, and MOA of HIV prevention or risk reduction interventions for specific sub-populations of pregnant substance-abusers, such as pregnant adolescents, homeless women, members of ethnic or racial minority groups that are over-represented in the HIV epidemic, women experiencing trauma, and HIV-positive pregnant substance abusers.

Development of methodologies or statistical approaches that facilitate the study of HIV prevention or risk reduction for pregnant women in drug-abuse treatment.

Studies developing, adapting or testing measurement instruments necessary to conduct HIV prevention and risk reduction intervention research in pregnant substance abusers in drug abuse treatment.

Studies to develop and/or test behavioral interventions to promote adherence to prenatal care regimens, and to determine the MOA of these interventions, in pregnant drug abusers in drug abuse treatment.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 research grant, the R21 exploratory/developmental grant, and the R03 small grant award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

NIDA intends to commit approximately $1.5 million in FY 2005 to fund 4-6 new and/or competitive continuation grants in response to this RFA. An applicant may request for the RO1 a project period of up to 5 years and a budget for direct costs up to $500,000 per year. For the R21, the project period is 2 years and direct costs may not exceed $275,000 for the entire project period. For the RO3, the project period is 2 years and direct costs of up to $50,000 for each of those years.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration 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. The earliest anticipated start date is September 2005.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An applicant may not submit more than one application in response to this RFA for which he or she is the Principal Investigator or Co-Investigator. An applicant who is the Principal Investigator on one application may serve as a consultant on other applications submitted in response to this RFA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): 02/21/2005
Application Receipt Date(s): 03/21/2005
Peer Review Date(s): 06/2005
Council Review Date(s): 09/2005
Earliest Anticipated Start Date: 09/2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Director - DA-05-008
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Director - DA-05-008
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by NIDA. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will not be reviewed.

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 NIDA in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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 or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
The expected date of awarding grant funding is September 30, 2005.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

If the grantee organization is set up to receive e-mailed awards from NIH, the award will be e-mailed to the authorized business official of the grantee institution. If the organization is not e-mailed enabled, one copy of the Notice of Award will be mailed to the authorized business official. The business official's office is responsible for sending a copy of the award to the Principal Investigator.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Melissa W. Racioppo. Ph.D.
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4230, MSC 9593
Bethesda, MD 20892-9593
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2261
FAX: (301) 443-6814
Email: mraciopp@nida.nih.gov

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov

3. Financial or Grants Management Contacts:

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard , Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming@nida.nih.gov

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

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Cunningham, C. K., Balasubramanian, R., Delke, I., Maupin, R., Mofenson, L., Dorenbaum, A., Sullivan, J. L., Gonzalez-Garcia, A., Thorpe, E., Rathore, M., & Gelber, R. D. (2004). The Impact of Race/Ethnicity on Mother-to-Child HIV Transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. JAIDS-Journal of Acquired Immune Deficiency Syndromes, 36, 800-807.

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