dp12-001 foa final 1.23.12.doc

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 1. Overview Information

Announcement Type

New

Key Dates Publication Date

To receive notification of any changes to RFA-DP-12-001, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 1702(a)(2)(3) of the Public Health Service Act, 42 U.S.C. 300u-1(a)(2) and (3).

Purpose

The purpose of the program is to develop and evaluate a clinic-based intervention that modifies the way reproductive health services are provided to high risk female teens aged 15-19, particularly those from racial and ethnic minority groups, to increase the use of dual protection strategies that concurrently protect against unintended pregnancies and sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV). This program addresses the “Healthy People 2020” overarching goal for disparities (to achieve health equity, eliminate disparities, and improve the health of all groups) as well as the focus areas of family planning, sexually transmitted diseases and HIV:

· Family Planning (FP)-10: Increase the proportion of sexually active persons aged 15 to 19 years who use condoms to both effectively prevent pregnancy and provide barrier protection against disease.

· FP-11: Increase the proportion of sexually active persons aged 15 to 19 years who use condoms and hormonal or intrauterine contraception to both effectively prevent pregnancy and provide barrier protection against disease.

· FP-8: Reduce pregnancy rates among adolescent females.

· STD-1: Reduce the proportion of adolescents and young adults with chlamydia trachomatis infections.

· STD-6: Reduce gonorrhea rates.

· HIV-1: Reduce the number of new HIV diagnoses among adolescents and adults.

This program is also aligned with the National Prevention Strategy (i.e., recommendations for Elimination of Health Disparities and for Reproductive and Sexual Health); the CDC Winnable Battle areas of Teen Pregnancy and HIV; the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) priorities of Health Equity and Research Translation; and the Division of Reproductive Health priorities of Unintended Pregnancy Prevention and Women’s Reproductive Health.

Through this announcement, the CDC intends to fund projects that have the potential to yield high impact research results by reducing public health burden and improving population health on a large scale.

Nature of the Research Opportunity

The nature of this research opportunity is to develop and evaluate a clinic-based intervention that modifies the way reproductive health services (e.g., contraceptive counseling, provision of contraceptive methods, STD/HIV screening/treatment) are provided to high risk female teens aged 15-19, particularly those from racial and ethnic minority groups, in order to increase the use of dual protection strategies that concurrently protect against unintended pregnancies and STDs, including HIV. Incorporating elements of a sexual health framework (e.g, support teens to understand and weigh the responsibilities, risks and outcomes of sexual behaviors, and have a positive approach to relationships), the intervention should:

1) Improve access to elements of effective dual protection strategies (e.g., long-acting reversible contraceptive methods [LARCs], STD/HIV testing/treatment);

2) Address motivations to use dual protection (e.g., knowledge and attitudes about pregnancy and STD prevention, decision making skills, healthy relationships); and

3) Provide ongoing support for adherence to dual protection.

To assess the impact of the intervention, a rigorous evaluation will be conducted with both biological (e.g., pregnancy, STDs) and behavioral (e.g., uptake of dual protection, adherence to dual protection) outcomes.

Background

Unintended pregnancy and STDs, including HIV, have substantial adverse health, social, and economic impacts. In the U.S., racial and ethnic minority teens are affected disproportionally by pregnancy and STDs. For example, the teen pregnancy rate among black youth is over two-times that of white teens1 and it is estimated that 50 percent of black teen girls will become pregnant at least once before they turn 20, compared to 19 percent of white teenage girls.2 Additionally, nearly half of U.S. black teenage girls have at least one of the five most common STDs, a rate that is over two- times that for white teens.3 These disparities may result in part from differences in sexual activity or contraceptive use. For example, in 2009, black high school students (65%) were more likely than white students (42%) to report having ever had sex and among sexually active students, more white (27%) than black (8%) students reported using birth control pills before the last time they had sex.4 Practices shown to reduce unintended pregnancy or STDs alone could be combined for dual protection. Increasing use of long-acting, reversible contraceptive methods (LARCs), including intrauterine devices (IUDs) and contraceptive implants, should substantially decrease unintended pregnancy rates, given that these methods are highly effective and require little user adherence. However, less than 4% of U.S. teens using contraception use LARCs, but over half use oral contraceptives,5 which require daily user adherence. Condoms and STD screening and treatment help prevent new STD infections. Yet, many U.S. teens do not use condoms consistently or correctly and rates of STD testing are low. In 2006-08, only half of sexually active female teenagers reported using condoms every time they had sex during the previous 4 weeks.6 Additionally, among sexually active females aged 16 to 20 just over half of those enrolled in Medicaid plans and 40% of those enrolled in commercial insurance plans were screened for chlamydia in 2008.7 As few interventions have attempted to increase dual protection use and none have shown reductions in pregnancy or STDs, interventions that can effectively promote uptake and adherence to effective dual protection strategies are needed, particularly for high risk groups.

References

1. Kost K, Henshaw S and Carlin L. U.S. Teenage Pregnancies, Births and Abortions: National and State Trends and Trends by Race and Ethnicity, 2010, available at http://www.guttmacher.org/pubs/USTPtrends.pdf.

2. The National Campaign to Prevent Teen and Unplanned Pregnancy analysis of Martin, J.A., Hamilton, B.E., Sutton, P.D., Ventura, S.J.., Menacker, F., & Kirmeyer, S. (2006). Births: Final data for 2004. National Vital Statistics Reports, 55(1); Ventura, S.J., Abma, J.C., Mosher, W.D., & Henshaw, S. (2008). Estimated Pregnancy Rates by Outcome for the United States, 1990-2004. National Vital Statistics Reports, 56(15), available at http://www.thenationalcampaign.org/resources/pdf/Briefly_PolicyBrief_RacialEthnicDisparities.pdf

3. Forhan SE, Gottlieb SL, Sternberg MR, Xu, F, Datta SD, McQuillan GM, et al., 2009. Prevalence of sexually transmitted infections among female adolescents aged 14 to 19 in the United States. Pediatrics, 124(6), 1505-1512.

4. Youth Risk Behavior Surveillance—United States, 2009. Surveillance Summaries, June 4, 2010. MMWR; 59(SS-5).

5. Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. National Center for Health Statistics. Vital Health Stat 23(29). 2010.

6. Martinez G, Copen CE, Abma JC. Teenagers in the United States: Sexual activity, contraceptive use, and childbearing, 2006–2010 National Survey of Family Growth. National Center for Health Statistics. Vital Health Stat 23(31). 2011.

7. National Committee for Quality Assurance. The state of healthcare quality 2009. Washington (DC): National Committee for Quality Assurance; 2009. p.37-38.

Scientific knowledge to be achieved through this FOA

Research is needed to develop culturally tailored, scientifically validated interventions for teens at high risk for pregnancy and STDs. It is anticipated that this research will build on the Division of Reproductive Health’s research on the contraceptive and disease prevention practices of black teens and young adults in order to identify innovative modifications to clinical reproductive health service delivery for teens that will lead to:

1) Increased uptake of effective dual protection strategies;

2) Improved adherence to dual protection strategies; and

3) Reductions in pregnancy and STDs and their associated consequences.

To ensure that the intervention is culturally appropriate and that there is adequate statistical power for the evaluation, the target population should be limited to one racial or ethnic minority group in one fairly well-defined geographic area (e.g., black teens living in an urban area with high STD rates and high rates of teen births or teen pregnancies). A focus on one racial or ethnic minority group will allow for a more tailored intervention that can more adequately address specific attitudes, beliefs and group norms. In addition, an effective and scalable intervention for a racial or ethnic minority group will contribute to reductions in racial and ethnic disparities in teen pregnancy and STDs.

Research objectives and approach

This FOA will build on current research to develop and test a clinic-based intervention to promote dual protection among 15-19 year old females who are at high risk for unintended pregnancy and STDs, who live in one well-defined geographic area and who are from one racial or ethnic minority group. The intervention to be developed and tested should be applicable to publicly funded family planning or community clinics (e.g., the Title X Family Planning program [Title X] Family Planning clinics, Federally Qualified Health Centers) that serve the target population, 15-19 year old sexually active female teenagers at high risk for pregnancy and STDs. The proposed multi-component intervention should not be an existing intervention that has already been rigorously evaluated nor be an adaptation of a rigorously evaluated intervention. However, it should combine intervention approaches or methodologies that have been individually proven or are individually shown promising for addressing unintended pregnancy, STDs, HIV, or other health issues (e.g., case management, group based care, tools for provider counseling, computer-based health education, social media). The intervention should be able to be integrated into clinical services, and not require support as a completely stand-alone service.

Objective 1: Develop a culturally appropriate, multi-component clinic-based intervention that promotes dual protection from pregnancy and STDs, including HIV, among high risk 15-19 year old sexually active females from one racial or ethnic minority group.

· Solicit stakeholder and target audience feedback on proposed intervention.

· Refine and finalize definitions of dual protection strategies and intervention content (i.e., factors that influence dual protection).

· Draft and produce detailed intervention materials, including (but not limited to) intervention manuals.

· Pilot test the intervention.

· Recruit and train staff to deliver the intervention.

Proposed intervention components/content should include, but not be limited to:

· The promotion of LARCs (IUDs, contraceptive implants) as “first-line” contraceptive methods and one component of dual protection.

· The promotion of dual protection strategies that might include, but not be limited to:

· Dual method use (i.e., LARCs or hormonal method in combination with consistent condom use);

· Consistent condom use alone;

· Strategies to prevent or mitigate STDs within the context of counseling about mutual monogamy (e.g., STD screening following U.S. Preventive Services Task Force (USPSTF) guidelines with appropriate treatment, partner notification and treatment (e.g., expedited partner therapy as permitted by state regulations) in combination with use of LARC or hormonal contraceptive methods; or

· Abstinence.

· Addressing factors that influence dual protection, (e.g., knowledge and attitudes about pregnancy, STD prevention, and sexual and reproductive health; decision making skills; and healthy relationships).

· The provision of on-going support for adherence to dual protection.

Objective 2: Evaluate the efficacy of the intervention with primary outcomes that include both biological (pregnancy, STD) and behavioral (uptake, adherence to dual protection, relationship quality) outcomes.

· Develop the research protocol for the study to evaluate the intervention and submit the protocol for human subjects review.

· Develop and pilot test assessment instruments.

· Develop manual of operations for the conduct of the study.

· Conduct the study to evaluate the intervention.

The research proposed to evaluate the intervention should use a rigorous design (e.g., randomized experimental design) and must include a comparison group that receives the standard of care services in the clinic(s) in which the intervention is being implemented. Primary outcomes should be proposed and should include biological outcomes (e.g., pregnancy and chlamydia, and/or gonorrhea), as well as behavioral outcomes (e.g., uptake of and adherence to dual protection strategies, influences on dual protection use that are addressed in the intervention). The research proposed should have a sufficient follow-up period (e,g., at least 12 months) to adequately assess biological outcomes of interest and a minimum sample size of 700 female teens from the proposed target population.

Objective 3: Plan for dissemination of findings and the intervention, if effective.

· Draft a dissemination plan that could guide efforts to disseminate the intervention to other publicly funded clinics in the state and/or region after the end of the project.

Timeline

The general timeline for the project will consist of 3 phases over 5 years.

Phase 1: Development (Months 1-12)

· Design the intervention components and develop draft materials

· Design the study to evaluate the intervention

· Develop the research protocol for the evaluation study and submit the protocol for human subjects review

Phase 2: Intervention implementation (Months 13-48)

· Finalize intervention materials (by 18 months)

· Pilot test the intervention, revise materials, produce sufficient materials for intervention (by 20 months)

· Recruit and train staff to deliver the intervention and to conduct the evaluation study

· Conduct the evaluation study including the enrollment of at least 700 participants followed for a minimum of 12 months

· Conduct quality assurance of intervention implementation and data collection

Phase 3: Study findings, publications, and dissemination (Months 49-60)

· Complete study data collection (by 51 months)

· Analyze data to assess the effectiveness of the intervention and submit papers reporting findings to peer-reviewed journals

· Draft a dissemination plan that could guide efforts to disseminate the intervention to other publicly funded clinics Section II. Award Information

Application Types Allowed

New

The NIH OER Glossary (http://grants.nih.gov/grants/glossary.htm) and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCCDPHP intends to commit approximately $300,000 including both direct and indirect costs in FY2012 to fund 1 application for the first 12-month budget period.

An applicant may request a project period of up to 5 years. The funding amount may be up to $850,000 (direct and indirect) each year for the 2nd, 3rd, and 4th years of the project, to support pilot testing, conducting, and evaluating the intervention; and may be up to $350,000 (direct and indirect) for the 5th year of the project, to support data analysis, report writing, and dissemination; subject to the availability of funds. The approximate total project period funded amount may not exceed $3,200,000.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($300,000), HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

· Nonprofits (Other than Institutions of Higher Education)

For- Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

· Indian/Native American Tribal Governments (Other than Federally Recognized)

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

· Native American tribal organizations (other than Federally recognized tribal governments)

· Faith-based or Community-based Organizations

· Regional Organizations

· Bona Fide Agents

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: http://www.dlis.dla.mil/Forms/Form_AC135.asp

· Central Contractor Registration (CCR) – must maintain current registration in CCR to be renewed annually.

· Grants.gov

· eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Central Contractor Registration and Universal Identifier Requirements

All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov (https://www.bpn.gov/ccr/default.aspx).

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 HHS/CDC support.

2. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html). Based on authorization language, this section should only be included in the FOA, if applicable.

3. Other Additional Information on Eligibility Number of Applications

Only one application per institution (normally identified by having a unique DUNS Number) is allowed.

HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

Eligible applicants must have evidence of access to one or more clinic sites that meets the criteria that follow. Evidence of access can be in the form of letters or written agreements with the proposed clinic sites. Eligible applicants must meet the following criteria:

· Must provide evidence, in the form of reports, letters or written agreements with study clinics, of access to a total of least 1,000 unique clients from the proposed target population (i.e., 15-19 year old sexually active females from one racial or ethnic minority group who live in a well-defined geographic location [see last bullet in this series]) receiving reproductive health services (see definition below) annually across the clinic site(s) where the intervention will be implemented and evaluated.

· Must provide evidence, in the form of letters or written agreements with study clinic(s), that each clinic site where the intervention will be implemented and evaluated provides reproductive health services to 15-19 year old females in the target population. Reproductive health services include: contraceptive services and related counseling (including the provision of long-acting contraceptive methods, i.e., intrauterine devices and contraceptive implants); STD and HIV prevention counseling, testing and referral; and pregnancy diagnosis and counseling.

· Must provide evidence, in the form of reports, letters or written agreements with proposed study clinic(s), that each clinic site where the intervention will be implemented and evaluated serves the target population of 15-19 year old sexually active females at high risk for STDs and pregnancy. High risk may be demonstrated by recent racial or ethnic minority group specific rates (within the last 5 years) of STDs (chlamydia, gonorrhea) and teen birth or pregnancy in either the clinic(s) themselves or in their catchment area(s) that are above the national rates for 15-19 year old females from the targeted racial or ethnic minority group. Information on national STD rates can be found here: http://www.cdc.gov/std/stats/ . Information on national teen birth and pregnancy rates can be found here: http://www.cdc.gov/TeenPregnancy/AboutTeenPreg.htm.

· If more than one clinic site is proposed for implementation and evaluation, the clinic sites must have contiguous catchment areas, be within the same Metropolitan Statistical area and serve similar populations. Evidence in the form of maps of clinic catchment areas to show contiguous boundaries should be provided.

Evidence for these criteria must be presented in Appendix A of the application.

If your application is incomplete or non-responsive to the requirements listed in this section, it will not enter into the review process.

As defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or Email: pgotim@cdc.gov for further instruction Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Letter of Intent 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 CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Michael A. Brown, MPH Extramural Research Program Office

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

4770 Buford Hwy, N.E., M/S F-46 Atlanta, GA 30341

Telephone: (770) 488-5118 Fax: (770) 488-7863

Email: mab5@cdc.gov FedEx address

4770 Buford Hwy, NE

Building 101, Room 3116 Atlanta, GA 30341 Required and Optional Components

A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

Research Plan Components/Attachments

The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consist of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components:

1. Introduction to Application

2. Specific Aims

3. Research Strategy

4. Inclusion Enrollment Report

5. Progress Report Publication List

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

The Research Plan narrative is comprised of components 2, 3, and 4 above. Component 4 (Inclusion Enrollment Report) applies only to renewal and revision applications for clinical research. Note that the Research Strategy is divided into three parts: 1) Significance, 2) Innovation, and 3) Approach.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed, with the following additional instructions: Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

The applicants’ research plan(s) should address activities they will conduct over the entire project period and must include the following items:

Introduction/Background

· Describe the demographics (e.g., age, race/ethnicity) of the clients served by the clinic(s) where the intervention will be implemented and evaluated. Include information on STD rates (chlamydia, gonorrhea) and pregnancy or birth rates for 15-19 year old females in the target population in either the clinic(s) themselves or in their catchment area(s), as well as in the state(s) in which the clinic(s) reside.

· Describe the clinic site(s). Include clinical and other reproductive health services provided to the target population at the proposed clinical site(s), including (but not limited to) contraceptive and STD services, health education, payment/reimbursement, staffing, and number of women in the target population who access services in a year. Also include information about funding sources, including receipt of Title X funds, grants for federally qualified health centers or other public funds.

· Describe research team’s experience developing and evaluating interventions aimed at improving reproductive health (e.g., HIV, STD, or pregnancy prevention) in female teens in the target population. Include information on experience with randomized controlled study designs for evaluating interventions.

· Describe research team’s experience working with the target population within the clinic site(s) where the intervention will be implemented and evaluated, including clinical experience of proposed staff.

· Demonstrate capacity to recruit a minimum of 700 15-19 year old female teens in the target population (i.e., at high risk for unintended pregnancy and STDs, of the same racial or ethnic minority group, and in the same well defined geographic area).

· Describe experience retaining high risk female teens, from the target population, in studies involving follow-up. Include steps taken to locate participants that are lost to follow-up.

· Provide letter(s) of support from proposed clinical site(s). In addition to a commitment to collaborate, the letter of support should identify proposed roles for clinical staff.

Specific Aims

· Specify overall aims or objectives for intervention development and evaluation.

Research strategy

· Define dual protection strategies to be promoted in the proposed clinic-based intervention, indicating whether and in what order of preference (e.g., hierarchy) strategies may be promoted. Justify basis for proposed dual protection strategies and preference, addressing ability of strategies to protect from pregnancy and/or STDs, and expected uptake of and adherence to strategies in the target population (e.g., extent to which teens are likely to use strategies given current patterns of condom and/or contraceptive use in the clinic or catchment area population).

· Describe key approaches or methodologies (e.g., case management, computer-based health education, group-based care) that will be combined for an intervention that will increase access to, promote and support dual protection among the target population. Describe whether and how any of these methodologies help increase access to elements of dual protection strategies, including LARCs and STD screening and treatment.

· Describe intervention content (i.e., identify factors influencing dual protection use) that will promote dual protection by increasing access, addressing motivation and supporting adherence to dual protection. Describe whether and to what extent they are informed by a sexual health framework.

· Describe how the proposed intervention approaches or methodologies will be integrated into ongoing services at the proposed clinical site(s).

· Describe whether and how the proposed intervention will appeal to the target population, and how it will be culturally appropriate.

· Describe approach to finalizing intervention parameters, including definitions of dual protection, primary and secondary intervention outcomes, intervention approaches or methodologies to be combined and intervention content (or factors influencing dual protection). Describe the role of your own previous research, the literature, best practices, stake holders and the target population in finalizing these parameters.

· Describe approach to developing content for and producing intervention materials. Identify the types of materials likely to be produced.

· Provide information on sample size calculations for the evaluation study. The study should be powered with respect to the primary outcome (pregnancy and chlamydia, and/or gonorrhea) and must take into account the unit of randomization (e.g., individual, group). The anticipated minimum sample size is approximately 700, with potentially higher sample sizes needed depending on study design, expected effect size, and expected rates of pregnancy and STDs.

· Describe approach for recruitment and retention of the target population

· Describe the evaluation design, level of rigor (e.g., experimental, quasi-experimental), method for assignment to intervention and control, and number of follow-up assessments and length of follow-up.

· Describe method of data collection and management.

· Provide a timeline for conducting follow-up assessments and collecting biological and behavioral data at a baseline and at subsequent time points during a minimum follow-up period of 12 months.

· Describe how study data will be analyzed to determine the efficacy of the intervention using appropriate statistical methods.

· Describe plans to share de-identified data with CDC for analyses

· Describe expected changes in biological and behavioral outcomes associated with the proposed intervention (e.g., specify baseline and post-intervention rates of pregnancy and select STDs).

· Describe expected contributions to the field (e.g., further understanding of dual protection in the target population, potential for dissemination to and sustainability of the proposed intervention in publicly funded clinics (e.g., Title X Family Planning clinics or Federally Qualified Health Centers).

Staffing and Milestones for Development and Implementation Phases

· Describe experience and expertise of key proposed staff, including ability to develop and implement the intervention and the valuation and to analyze data and publish in peer-reviewed journals.

· Identify tasks and a timeline for key intervention and protocol development activities to occur in the first 18 months of the project (i.e., development phase and first 6 months of intervention implementation phase). Include milestones and/or measurable outputs that will be used to indicate progress toward having an Institutional Review Board (IRB)-approved protocol and all intervention materials pilot-tested, revised, and produced within the first 18 months of the project.

· Identify key milestones and staffing needs for implementation of the intervention and evaluation (e.g., recruitment and enrollment, intervention delivery, data collection, data management, data analysis, report writing).

· Provide evidence of a clear management and staffing plan for all 3 phases (i.e., Development, Intervention implementation, Study findings, publications and dissemination).

· Include in the budget planned travel each year to an annual meeting in Atlanta, GA to discuss study progress and any issues related to accomplishing project objectives.

Appendix

Do not use the appendix to circumvent page limits. A maximum of 12 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Page Limitations

All page limitations described in this individual FOA must be followed. For this FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 12 PDF files with a maximum of 50 pages for all appendices.

Format for Attachments

Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff.

CDC require all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

Failure to follow these requirements may lead to rejection of the application during agency validation or delay in the review process.

3. Submission Dates and Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS for guidance at least 3 calendar days before the deadline date.

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

5. Funding Restrictions Funds for research involving human subjects will be restricted until a Federalwide Assurance and Institutional Review Board Approval(s) are in place It should be noted that funds awarded under this announcement cannot take the place of funds that are currently being used to provide clinical services and contraceptives, including the provision of contraceptive methods and routine STD screening (or testing in the presence of symptoms) and treatment.

6. Other Submission Requirements and Information

Application Submission

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of this Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or…