dp15007amendmentpublication.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

AMENDMENT I. NEW DUE DATES AND SPECIAL DATE - Effectiveness of Teen Pregnancy Prevention

Programs Designed Specifically for Young Males

RFA-DP-15-007

Application Due Date: 03/06/2015

AMENDMENT I. NEW DUE DATES AND SPECIAL DATE - Effectiveness of Teen Pregnancy Prevention Programs Designed Specifically for Young Males

RFA-DP-15-007

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

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 Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title AMENDMENT I. NEW DUE DATES AND SPECIAL DATE - Effectiveness of Teen Pregnancy Prevention Programs Designed Specifically for Young Males Activity Code U01

AMENDMENT 2 includes:

1. Information on streamlining review of applications was added to 4. Review and Selection Process.

2. Questions from potential applicants and CDC responses was added to Section VIII. Other Information;

APPENDIX C: DP-15-007: Effectiveness of Teen Pregnancy Prevention Programs Designed Specifically for Young Males: cleared by February 13, 2015

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-007

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.946 93.297 Category of Funding Activity:

Health FOA Purpose A collaborative initiative between the HHS Office of Adolescent Health (OAH) and the Centers for Disease Control and Prevention (CDC), the purpose of this research opportunity is to rigorously evaluate innovative interventions designed for young men aged 15-24 years old to reduce their risk of fathering a teen pregnancy and that can be feasibly implemented in target settings (e.g., clinics, schools, community settings, youth-serving organizations, correctional settings). Up to three 5-year research projects will be funded, with at least one project evaluating an intervention targeted at young men aged 15-19 years.

Applicants will be funded as either Component A or B grantees, based on the readiness of the intervention to be rigorously evaluated. Component A applicants will submit a proposal using an existing intervention that has promising process data and/or some evidence of effectiveness, but that has not been rigorously evaluated. Component B applicants will submit a proposal using a partially developed intervention to be finalized prior to evaluation.

Both Component A and Component B projects will rigorously evaluate the interventions with an experimental approach, package efficacious interventions, and provide CDC and OAH with final intervention package materials to reproduce, publish, or otherwise use the work for public health purposes, and to authorize others to do so in accordance with applicable grant regulations (Part I).

and to authorize others to do so in accordance with applicable grant regulations (Part I).

Both Component A and Component B applicants will also obtain and conduct training and/or technical assistance (TTA) activities and services tailored to grantees’ needs to ensure high-quality implementation and rigorous evaluation of the proposed interventions (Part II).

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-007, 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.

Letter of Intent Due Date: 02/06/2015

AMENDMENT I.

New Letter of Intent Due Date: February 6, 2015

Application Due Date: 03/06/2015

AMENDMENT I.

Application Due Date has been changed from March 3, 2015 to March 6, 2015

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).

Scientific Merit Review: 04/01/2015

Secondary Review: 05/05/2015

Estimated Start Date: 09/30/2015

Expiration Date: 03/07/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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. 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 25 pages.

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

Executive Summary

Purpose. A collaborative initiative between the HHS Office of Adolescent Health and the Centers for Disease Control and Prevention, the purpose of this research opportunity is to rigorously evaluate innovative interventions designed for young men aged 15-24 years old to reduce their risk of fathering a teen pregnancy that can be feasibly implemented in target settings (e.g., clinics, schools, community settings, youth-serving organizations, correctional settings). Up to three 5-year research projects will be funded, with at least one project evaluating an intervention targeted at young men aged 15-19 years.

http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf be funded, with at least one project evaluating an intervention targeted at young men aged 15-19 years.

Projects will be funded under either Component A or B, based on the readiness of the intervention to be rigorously evaluated. Applicants will submit a proposal using either: A) an existing intervention that has promising process data and/or some evidence of effectiveness, but has not been rigorously evaluated; or B) a partially developed intervention to be finalized prior to evaluation.

Component A and Component B projects will rigorously evaluate the interventions with an experimental approach, package efficacious interventions, and provide CDC and OAH with final intervention package materials , to reproduce, publish, or otherwise use the work for public health purposes, and to authorize others to do so in accordance with applicable grant regulations. In this FOA, the set of activities on evaluation is referred to as Part I.

Component A and Component B projects will also obtain and provide training and technical assistance (TTA) that is tailored to the needs of the grantee (internal TTA) and the grantee’s external partners (external TTA) to ensure high-quality implementation and rigorous evaluation of the proposed interventions. In this FOA, the set of activities on training and technical assistance is referred to as Part

II.

Component A and Component B applications must address both Part I and Part II activities to be considered responsive.

Mechanism of Support. The funding mechanism is a cooperative agreement.

Funds Available and Anticipated Number of Awards. Funding used for selected research projects will enhance knowledge and evidence regarding effective approaches for working with young men to prevent and reduce teen pregnancy. The estimated total funding, covering both direct and indirect costs for the entire project period, for Component A and Component B combined, is $10,000,000. The intent is to commit a total of approximately $2,000,000 (direct and indirect) for the first 12-month budget period for two (2) to three (3) 5-year research projects, with at least one project evaluating an intervention targeted at young men aged 15-19 years. Two to three grantees will be awarded $666,000 to $1,000,000 (direct and indirect) costs in FY2015. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award may vary. The total amount awarded and the number of awards will depend upon the number, quality, and cost of the applications received. However, the total number of grantees will not exceed three and the total funding amount will not exceed $2,000,000 in FY2015. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications.

Funding Source: This FOA is funded by the HHS OAH Teenage Pregnancy Prevention Program (OAH) and the CDC Safe Motherhood Program (CDC). Part I activities are supported by OAH and Part II activities are supported by CDC. Projects will be funded either as Component A or B grantees, and will be funded with a combination of both Part I (OAH) and Part II (CDC) funds. Specifically, grantees will be awarded Part I funds of $533,000 to $800,000 plus Part II funds of $133,000 to $200,000 for combined direct and indirect costs in FY2015.

Because awardees will be funded with two sources of funds, applicants are expected to submit a single budget, but that budget must delineate and distinguish Part I and Part II activities and related planned expenditures.

Budget and Project Period. The estimated total funding, covering both direct and indirect costs for the entire project period, for Component A and Component B combined, is $10,000,000. Part I funds will include up to $8,000,000 in funds from OAH that are available for two to three research projects for up to 5 years, with at least one project evaluating an intervention targeted at young men aged 15-19 years. Part II funds will include up to $2,000,000 in funds from CDC that are available for to the Component A and B awardees for training and/or technical assistance (TTA) activities and services that help ensure high-quality implementation and rigorous evaluation of the proposed interventions.

The project period will run from 09/30/2015 to 09/29/2020.

The total funding (direct and indirect for the first year [12-month budget period]) is approximately $2,000,000 for Part I and Part II activities. Total Part I OAH funding (direct and indirect) for the first year (12-month budget period) is approximately $1,600,000. Total Part II CDC funding (direct and indirect) for the first year (12-month budget period) is approximately $400,000. The first year of the project period will run from 09/30/2015 to 09/29/2016.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

Application Type. New Special Date. CDC will conduct one teleconference for prospective applicants. This session will provide information about the FOA and will answer questions pertinent to preparing applications in response to this FOA.

Teleconference Date: January 14, 2015 at 1:00 p.m. (EST) Call-in Number: 1-877-985-9419 Participant Passcode: 773482

NEW - A second teleconference for prospective applicants has been scheduled:

* Teleconference Date: January 26, 2015 at 1:00 p.m. (EST)

* Call-in Number: 1-800-369-1782

* Participant Code: 1980059

Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: (770) 488-2783.

This FOA will be posted at http://www.cdc.gov/chronicdisease/about/foa.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Division H, Title II of the Consolidated Appropriations Act, 2014 (Public Law No. 113-76), and the Continuing Resolution thus far for FY 2015 (Public Law No.

113-164), and Section 317K and 301(a) of the Public Health Service Act, 42 U.S.C. 247b-12, 241(a).

Office or Management and Budget (OMB) Paperwork Reduction Act (PRA) requirements are expected to apply.

1. Background and Purpose http://www.cdc.gov/chronicdisease/about/foa.htm

Although teen birth rates (defined as live births per 1,000 15–19 year-old U.S. females) are declining, nearly 275,000 infants were born to teen mothers aged 15–19 years in 2013 (Hamilton, 2014), and the U.S. teen birth rate remains higher than in other developed countries (Penman-Aguilar, Carter, Snead, & Kourtis, 2013). Furthermore geographic, socioeconomic, and racial/ethnic disparities in teen birth rates persist. In 2012, non-Hispanic black and Hispanic teen birth rates were still more than two times higher than birth rates for non-Hispanic white teens (Martin, Hamilton, Osterman, Curtin, & Mathews, 2013).

Most pregnancies among female teens (82%) are unintended (Finer and Zolna 2014), and teen pregnancy and childbearing may bring substantial social and economic costs through immediate and long-term impacts on teen mothers and their children. Only about 50% of teen mothers receive a high school diploma by 22 years of age, versus approximately 90% of women who have not given birth during adolescence (Perper, Peterson, & Manlove, 2010). Children born to teen mothers experience poorer health and lower academic achievement, higher rates of teen pregnancy for female children, and higher rates of incarceration for male children (Hoffman 2008).

In 2012, teen fatherhood occurred at a rate of 13.8 births per 1,000 men aged 15-19 (Martin, Hamilton, Osterman, Curtin, & Mathews, 2013) and resulted in approximately 156,000 births. According to the 2002 National Survey of Family Growth, 15% of males fathered a child while under the age of 20 and rates were highest among non-Hispanic Black and Hispanic teens (Martinez, Chandra, Abma, Jones, & Mosher, 2006).

Data suggest that teen fathers attend fewer years of school and are less likely to graduate from high school (Fletcher & Wolfe, 2012). In addition, males just beyond their teen years (aged 20-24) father a higher proportion of children born to teen mothers than males aged 19 and younger (Elo, King, & Furstenburg, 1999; Males, 1995). Thus, it is important to reach both teenage as well as young adult males in their early 20s (hereafter referred to as “young men”) in teen pregnancy prevention efforts. Although typically teen pregnancy is defined by the age of the mother, for the purposes of this FOA, we are interested in those young men at risk of fathering a teen pregnancy, i.e., either teen males who father a pregnancy or men beyond their teen years who father a pregnancy to a female teen.

Initiatives to prevent teen pregnancy have focused primarily on the role of female teens; however, as described above, young men can also play an important role in preventing teen pregnancy and should be actively engaged in pregnancy prevention efforts. Partner involvement in contraceptive decision making has been shown to increase use of effective methods of pregnancy prevention, including the use of dual protection (i.e., the use of condoms plus hormonal methods for the prevention of pregnancy and sexually transmitted infections [STIs]) (Kerns 2003, Harper 2004, Kraft 2010, Cox 2010). This influence may be based on higher levels of contraception-related communication, joint responsibility, and decision-making between partners, as well as male partners’ knowledge and attitudes about contraceptive methods (including condoms), support for use of moderately or highly effective methods, and desire for pregnancy prevention. These and other mediators can be addressed in interventions for males, which is why it is so important for this funding opportunity to study initiatives designed to focus on young men. Despite the important role of the male partner in teen pregnancy prevention, working with young men is an underused approach to teen pregnancy prevention (TPP).

Implementing evidence-based interventions (EBI) for sexual risk reduction in clinical and community settings is a significant teen pregnancy prevention strategy supported by the Centers for Disease Control and Prevention (CDC) and the HHS Office of Adolescent Health (OAH) (OAH; U.S. Department of Health and Human Services, 2012). Yet, there are few interventions that are designed specifically for young men and that have been shown to be effective in reducing teen pregnancy. A systematic review (http://tppevidencerevi ew.aspe.hhs.gov/ReviewProtocol.aspx)conducted in 2012 by Mathematica Policy Research (U.S.

Department of Health and Human Services, 2012) and updated in 2014, identified 35 rigorously evaluated interventions found to have an impact on sexual risk behaviors, teen pregnancy, and/or STIs, known as the HHS Teen Pregnancy Prevention Evidence Review http://tppevidencereview.aspe.hhs.gov/EvidencePrograms .aspx (hereafter referred to as the “Evidence Review”). Most of these interventions included male and female participants, with only one intervention designed specifically for males (Magura, Kang, & Shapiro 1994).

http://tppevidencereview.aspe.hhs.gov/ReviewProtocol.aspx) http://tppevidencereview.aspe.hhs.gov/ReviewProtocol.aspx) http://tppevidencereview.aspe.hhs.gov/EvidencePrograms.aspx

These interventions were typically designed as HIV/STI prevention interventions and provide participants with information about condoms, but offer them little information about other contraceptive options. These interventions typically lack a focus on the shared responsibility of contraceptive decision making or on sexual and reproductive health services. Interventions exist that focus on male-specific risk and protective factors for teen pregnancy (e.g., Gottesgen & Philiber, 2001; Ricardo, Nascimento, Fonseca & Segundo, 2010; Smith, Weinman, Buzi, & Benton, 2004; Tello, Cervantes, Cordova, & Santos, 2010), but results from rigorous evaluations of these interventions have not been reported in the peer-reviewed literature.

Purpose:

A collaborative initiative between the HHS Office of Adolescent Health (OAH) and the Centers for Disease Control and Prevention (CDC), this research opportunity is a part of HHS-funded research and demonstration activities to support the evaluation of innovative interventions designed for young men aged 15-24 years old to reduce their risk of fathering a teen pregnancy. Interventions should target young men at high risk of fathering a teen pregnancy (e.g., young men at risk of health disparities due to low socioeconomic status (SES), race/ethnicity [with respect to high pregnancy rates among female teens who are Black or African American, Hispanic or Latino, Native Hawaiian or other Pacific Islander, American Indian and Alaska Native], exposure to social determinants negatively affecting health [e.g., inadequate housing, lower educational attainment, stressful neighborhood environment, high community unemployment, etc.], being out of school [for young men under age 18], unemployment [for young men ages 18-24], living in foster care, homelessness, experiencing trauma or domestic violence, involvement with the criminal justice system, substance abuse) (Adapted from CDC Office of Minority Health and Health Equity, HHS Office of Adolescent Health, and John Snow, Inc.). Interventions should primarily focus on a selected age group within the ages of 15 through 24 years (e.g., young men in high school; young men ages 20-24).

Projects will test innovative interventions designed for males that can be feasibly implemented in target settings (e.g., clinics, schools, community settings, youth-serving organizations, correctional settings).

The following is a summary of the application structure:

Structure and Required Elements for Component A and Component B Applications

Component A (Existing Intervention) Component B (Partially Developed Intervention)

Part I (implementation and evaluation) Part I (implementation and evaluation)

Part II (training and technical assistance) Part II (training and technical assistance)

Applicants will be funded as either Component A or Component B grantees, based on the readiness of the intervention to be rigorously evaluated. Component A applicants will submit a proposal using an existing intervention that has promising process data and/or some evidence of effectiveness, but that has not been rigorously evaluated. Component B applicants will submit a proposal using a partially developed intervention to be finalized prior to evaluation. Both component A and Component B projects will rigorously evaluate the interventions with an experimental approach, package efficacious interventions, and provide CDC and OAH with final intervention package materials, to reproduce, publish, or otherwise use the work for public health purposes, and to authorize others to do so in accordance with applicable grant regulations.

Component A: Applicants for Component A will have an existing intervention that:

a) Is implementation-ready (although the intervention materials may need some minor editing before conducting a rigorous evaluation) and has been implemented in its entirety at least once (and preferably many times) in one or more settings; and

b) Has promising process data (e.g., feasibility and acceptability among the target population and setting) and/or some evidence of effectiveness (e.g., pre-posttest findings of increased intention to use condoms and/or highly or moderately effective contraception, increased knowledge of contraceptive methods, and/or highly or moderately effective contraception, increased knowledge of contraceptive methods, increased partner communication self-efficacy regarding contraceptive use, etc.), but has not been rigorously evaluated (i.e. randomized controlled trial or non-randomized design with external comparison group) to date.

Component B: Applicants for Component B will have a partially developed intervention to be completed prior to the evaluation. Successful applicants will have conducted formative research and/or consulted with members of the target population, initiated development of the intervention, and will have drafts of intervention materials. Under this component, interventions will not be implementation-ready at the time of application; applicants will have up to 18 months from notice of award to finalize the intervention, including detailed intervention materials, (e.g. logic model, core elements, curricula, training manuals) prior to implementation and rigorous evaluation.

Component A and Component B projects will address two sets of activities:

Part I: Implementation and Evaluation. Applicants will rigorously evaluate the interventions with an experimental approach, package efficacious interventions, and provide CDC and OAH with final intervention package materials, to reproduce, publish, or otherwise use the work for public health purposes, and to authorize others to do so in accordance with applicable grant regulations.

Part II: Training and Technical Assistance. Applicants will also conduct training and technical assistance (TTA) that is tailored to the needs of the grantee (internal TTA) and the grantee’s external partners (external TTA) to ensure high-quality implementation and rigorous evaluation of the proposed interventions. Applicants for both Component A and Component B may propose to use Part II funds toward internal, external, or a combination of internal and external training and technical assistance, depending on the needs of the grantee.

Applicants for Component A must address both Part I and Part II activities to be considered responsive to the intent of this FOA.

Applicants for Component B must address both Part I and Part II activities to be considered responsive to the intent of this FOA.

Applicants funded under this FOA, whether Component A or Component B, must acknowledge receipt of funds from the two funding sources, OAH and CDC, and must address budget requirements to delineate and distinguish Part I and Part II activities and expenditures.

Healthy People 2020 and other National Strategic Priorities

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:

1) FP-6 Increase the proportion of females at risk of unintended pregnancy or their partners who used contraception at most recent sexual intercourse.

2) FP-7 Increase the proportion of sexually experienced persons who received reproductive health services.

3) FP-8 Reduce pregnancies among adolescent females.

4) 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.

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

6) STD-6: Reduce gonorrhea rates.

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

This research opportunity is aligned with My Brother’s Keeper (http://www.whitehouse.gov/my-brothers -keeper), a White House initiative to address persistent opportunity gaps faced by boys and young men of http://www.whitehouse.gov/my-brothers-keeper http://www.whitehouse.gov/my-brothers-keeper

-keeper), a White House initiative to address persistent opportunity gaps faced by boys and young men of color, and the White House Fatherhood Initiative and Mentoring Initiative (http://www.whitehouse.gov /champions/fatherhood). It supports 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 http://intranet.cdc.gov/od/winnablebattles/teenpregnancy and HIV and the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) priorities of increasing health equity and conducting research. The research to be conducted addresses the Division of Reproductive Health priorities of Unintended Pregnancy Prevention and Women’s Reproductive Health and two key strategic areas of focus within these priorities: Teen Pregnancy Prevention and Family Planning Methods, Services, and Use.

This funding opportunity announcement is one of a series of five funding opportunities, each with a different focus, available through the HHS Office of Adolescent Health’s Teen Pregnancy Prevention Program.

Applicants may apply for more than one FOA. This FOA provides information to apply for FOA RFA-DP-15-007– Effectiveness of Teen Pregnancy Prevention Programs Designed Specifically for Young Males. Other anticipated funding opportunity announcements from OAH include:

Capacity Building to Support Implementation of Evidence-Based TPP Programs (OAH-15-0003) Implementing Evidence-Based Teen Pregnancy Prevention Programs to Scale in Communities with the Greatest Need (OAH-15-0004) Supporting and Enabling Early Innovation to Advance Adolescent Health and Prevent Teen Pregnancy

(OAH-15-0006)

Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy (OAH-15-0007)

Information about these anticipated FOAs is available from the HHS grant forecast which can be found at:

http://www.acf.hhs.gov/hhsgrantsforecast/.

Public Health Impact

Through this announcement, HHS (OAH and CDC) intends to fund projects that have the potential to yield high-impact research results by reducing public health burden and improving population health. This work will expand on a limited research base by providing much needed investigation on how to develop, implement, and evaluate interventions related to teen pregnancy prevention and sexual and reproductive health for young men. The research also has the potential to expand evidence-based TPP and sexual and reproductive health interventions, thereby increasing the arsenal of strategies to reduce risk behaviors and improve sexual and reproductive health for young men and their female partners, and reduce unintended and teen pregnancy in the United States.

Relevant Work

Refer to Background and Purpose section.

2. Approach

The project goal is to increase the number of evidence-based TPP interventions for 15-24 year-old young men at high risk for fathering a teen pregnancy and make such interventions available to the broader field to use in their public health efforts. To meet this goal, grantees will rigorously evaluate either an existing intervention that has not been rigorously evaluated (Component A) or a partially developed intervention to be finalized prior to evaluation (Component B). Through research and intervention implementation activities, the announcement also aims to expand the knowledge base on developing, implementing, and evaluating TPP interventions for young men.

Objectives/Outcomes http://www.whitehouse.gov/my-brothers-keeper http://www.whitehouse.gov/my-brothers-keeper http://www.whitehouse.gov/champions/fatherhood http://www.whitehouse.gov/champions/fatherhood http://intranet.cdc.gov/od/winnablebattles/teenpregnancy

Part I. Implementation and Evaluation

Component A applications must identify an existing intervention that has promising process data and/or some evidence of effectiveness, but has not been rigorously evaluated. Component B applications must identify a partially developed intervention to be finalized prior to evaluation. Component A and B applications must include a summary of the intervention; a logic model (including: the intervention goals and objectives and the intervention’s theoretical basis); the age range of participants and the target population;

and a summary of all completed intervention materials (or draft materials for Component B), including implementation manual(s). Applicants are encouraged to provide all intervention materials as page limits for the Appendices permits.

Interventions that are not acceptable for this funding announcement include those already included as an evidenced-based program as determined by the Evidence Review; those in CDC’s Compendium of Evidence-Based Risk Reduction Interventions for HIV Prevention (http://www.cdc.gov/hiv/prevention/resea rch/compendium/rr/complete.html); those currentlyundergoing a rigorous evaluation under funding opportunity announcement OPHS/OAH-TPP PREP Tier2-2010 (http://www.hhs.gov/ash/oah/news/assets /funding_announcment_research.pdf); or those that replicate or make changes (adaptations) to these interventions (See a complete list in FOA Appendix A).

The proposed intervention should be targeted to young men within the age range of 15-24 years who are at high risk for fathering a teen pregnancy and should fill a significant gap in evidence-based TPP interventions (e.g., critical target populations and/or settings that are not reached by existing interventions). Interventions must be developed with significant input from the target population and based on theoretical models to innovatively address the unique risk and protective factors associated with fathering a teen pregnancy.

Interventions may address factors at the individual, interpersonal relationship, community, structural, or multiple levels to affect behavioral, clinical, or biological outcomes. Interventions must be feasible to implement in target settings (e.g., clinics, schools, community settings, youth-serving organizations, correctional settings) during the project period and for future implementation in real-world settings.

Applicants should explain how the proposed target setting(s) fit well with the intervention and target population and have the potential to reach large numbers of young men.

Applicants will ensure that program materials, including all materials associated with the intervention and any supplemental materials (i.e. curricula, facilitator and participant manuals, videos, podcasts, posters, scripts, participant booklets, pamphlets, and handouts) are medically accurate, complete, and age appropriate, and should ensure that all materials are culturally and linguistically appropriate, and sensitive to and inclusive of Lesbian Gay Bisexual Transgender and Questioning (LGBTQ youth). Interventions should be implemented in environments that are positive, safe, supportive, and healthy for all youth and their families.

To ensure that the most current science is reflected in the intervention materials, successful applicants will be required to submit all intervention materials prior to use in the project to OAH for a medical accuracy review.

To ensure that the most current science is reflected in the intervention materials, successful applicants will be required to submit all intervention materials to be used in the project to CDC and OAH for a medical accuracy review. This review of intervention materials will be conducted after an application is approved for funding. The successful applicant will be notified of any content that needs modification and will make any necessary changes. The intervention materials may not be used in the project until after the medical accuracy review is final and any required modifications are made. The grantee must verify that all required modifications have been made and accepted by CDC and OAH.

Applicants must demonstrate capacity and experience accessing and working with large groups of young men, including evidence of successful enrollment in programs, intervention studies or trials, and the expertise to implement the intervention with fidelity and conduct a rigorous evaluation. Applicants may use partnerships to fulfill the capacity needs for successfully completing the project (e.g., intervention developer collaborating with a clinic and/or youth-serving organization to develop and implement the intervention;

http://www.cdc.gov/hiv/prevention/research/compendium/rr/complete.html http://www.cdc.gov/hiv/prevention/research/compendium/rr/complete.html http://www.hhs.gov/ash/oah/news/assets/funding_announcment_research.pdf partnering with a research firm to conduct the evaluation). The applicant PI(s) and their primary partners will hereafter be referred to as the Study Team. Such partnerships should be documented through written and signed agreements prior to application submission, and preferably have previous successful collaborations together. Applicants may also use Part II funds to increase the capacity of internal and external staff (see below). Applicants should engage stakeholders in the form of a community advisory board (CAB), which includes representation from the target population and target settings. The CAB should provide input throughout the project period to ensure that interventions resonate with the target population and are feasible to implement in the target setting. The CAB should also provide input on evaluation activities, such as participant recruitment and retention.

The awards under this funding opportunity are cooperative agreements, which require substantial federal programmatic involvement throughout the project period. This will include CDC’s close collaboration with recipients to: ensure adherence to project aims; review and provide input on intervention and evaluation materials and study analyses; develop outcome-focused and other project-related manuscripts; review training and technical assistance plans; provide ongoing training, technical assistance, oversight, troubleshooting; and facilitate coordination with other agencies and offices within HHS. Recipients will submit all de-identified study data to CDC over a secure data network. As described above, recipients will also provide CDC and OAH with final intervention package materials.

All funded grantees will collect and report on a common set of performance measures to assess program implementation and whether the program is observing intended program outcomes. Performance measures must be collected for every participant (at the individual level) served by the project using non-identifying identification numbers. The broad categories of the measures that grantees are expected to collect and report includes reach, dosage of intervention (individual-level attendance), fidelity and quality, linkages and referrals to healthcare services, cost of implementing the program, sustainability, partnerships, trainings, and dissemination. Please refer to the detailed list of measures in Appendix B.

Applicants should review relevant state laws, school district policies, and other administrative procedures of their sites or partner organizations to ensure the feasibility of data collection. If necessary, applicants should obtain any required permissions to collect these data. Applicants should demonstrate/indicate within the application that they have permissions to collect these data and report them to CDC as part of this project, as well as demonstrate the capacity to do so at the individual level. There are no exceptions or waivers from this requirement.

Part II. Training and Technical Assistance

Component A and B applications must include a detailed description of a plan for training and technical assistance (TTA) that is tailored to the needs of the grantee (internal TTA) and the grantee’s external partners (external TTA) to ensure high-quality implementation and rigorous evaluation of the proposed interventions. Applicants for both Component A and Component B may propose to use Part II funds toward internal, external, or a combination of internal and external training and technical assistance, depending on the needs of the grantee.

Part I.

Objective 1: Develop and prepare the proposed intervention for a rigorous evaluation. Below are some of the activities anticipated for objective 1.

Component A:

Identify and convene a community advisory board (CAB) Refine and finalize intervention materials (as applicable) to prepare for the evaluation, including but not limited to a logic model, core elements, curricula, and training manuals Pilot test feasibility and appropriateness of intervention with target population and setting(s)

Component B:

Identify and convene a community advisory board (CAB)

Identify and convene a community advisory board (CAB) Finalize intervention approaches and produce detailed intervention materials, including but not limited to a logic model, core elements, curricula, and training manuals Pilot test feasibility and appropriateness of intervention with target population and setting(s)

Objective 2: Evaluate the intervention. There will be two evaluation elements: a quantitative efficacy evaluation and a qualitative evaluation. Below are the parameters for the evaluation design and some of the anticipated activities for objective 2.

Components A and B:

Develop and implement quantitative efficacy evaluation of the intervention

The proposed evaluation plan should address the required elements outlined in the Evidence Review (http://tppevidencereview.aspe.hhs.gov/EvidencePrograms.aspx) (see Appendix A for a summary). Evaluations implementing randomized controlled trials (RCTs) are preferred, though rigorous evaluations with non-randomized designs that include an external comparison group are acceptable when an RCT is not feasible. Cooperative agreement recipients and Study Team partners will receive training and technical assistance from CDC on developing and implementing research protocols that meet HHS evidence standards.

Applicants should provide a power analysis that demonstrates the proposed sample size after anticipated attrition is sufficient to detect an intervention effect, and that includes a sufficient post-intervention follow-up period to adequately assess outcomes of interest (at least 24 months for Component A and 12 months for Component B).

Evaluation outcomes

The primary outcomes to be assessed are increased: condom use; abstinence from vaginal intercourse (primarily for teen males); use of sexual and reproductive health services;

female partners’ use of moderately effective contraception (hormonal injection; patch;

ring; pill) or highly effective long-acting reversible contraception (implant; IUD); and dual use of condoms and moderately or highly effective contraception. The applicant should address possible limitations in assessing outcomes related to female-controlled methods of contraception (i.e., moderately or highly effective contraceptive methods), since these methods are not under the direct control of the male intervention participants.

Measures will need to be designed to maximize reliability.

Where possible, the evaluation should assess pregnancies and births among teen female partners and incidence of STIs among male participants Key intermediate outcomes based on the intervention logic model should be assessed

Implementation of the evaluation should include process monitoring and quality assurance activities; protections of human subjects; baseline and follow-up data collection for intervention and comparison groups; and data security, cleaning, and analysis activities, including assessment of intervention efficacy.

Develop and implement qualitative evaluation of the intervention

The purposes of a qualitative evaluation element are to provide context to the quantitative efficacy results and enhance understanding of intervention, such as the components that resonate with participants and mediate behavior change, barriers to behavior change and intervention attendance, and in-depth feedback on participants’ experiences in the intervention. This evaluation element should also assess facilitators and barriers to program implementation, cost of implementing the intervention, and provide information to finalize intervention packaging. In addition, these data may provide valuable information to inform future efforts to develop and implement teen pregnancy prevention interventions for young men.

Implementation should include process monitoring and quality assurance activities; data collection procedures; and data security, cleaning, transcription, and analysis activities.

Objective 3: Develop and implement a plan to package efficacious interventions and disseminate study results and products. Below are some of the activities anticipated for objective 3.

Components A and B:

Complete packaging of efficacious interventions

Use lessons learned from the quantitative and qualitative evaluations to refine intervention materials, including but not limited to: the logic model, implementation and training curricula, technical assistance guidance for implementation, information on the intervention’s logistics and costs, and any process and outcome monitoring tools.

Prepare a package of the completed intervention that can be shared with other teen pregnancy preventions programs. The package should address required elements as outlined at: http://www .hhs.gov/ash/oah/oah-initiatives/for-grantees/program-guidance/Assets/tpp_packaging_guidance .pdf

Prepare intervention outcome-related manuscript for submission to a peer-reviewed journal; Prepare manuscript and/or report on the findings from the qualitative evaluation

Part II.

Objective 4: Develop and implement a detailed plan for training and technical assistance (TTA) that is tailored to the needs of the grantee (internal TTA) and the grantee’s external partners (external TTA) to ensure high-quality implementation and rigorous evaluation of the proposed interventions. Below are some of the activities anticipated for objective 4.

Components A and B:

Develop a detailed internal and/or external training and technical assistance (TTA) plan.

Internal TTA refers to training and technical assistance that is delivered to the grantee or the grantee staff. Internal TTA could be provided by an expert member of the grantee staff, member of the Study Team, consultant, expert, or organization (“TTA providers”).

External TTA refers to training and technical assistance that is provided to parties who are not part of the grantee’s staff or Study Team. External TTA could be provided by an expert member of the grantee staff, member of the Study Team, consultant, expert, or organization (“TTA providers”).

Examples of areas and types of consultation, technical assistance, and/or training that might be sought include, but are not limited to: designing, implementing, and packaging sexual health interventions and studies focused on young men; conducting randomized controlled trials in accordance with consolidated standards of reporting trials (CONSORT) guidelines; recruiting and retaining young male participants; strengthening a male focus in youth-serving intervention settings (such as clinics, schools, corrections facilities, etc.); training program, clinical, or other staff to implement interventions with fidelity; evaluating interventions targeting young men; and packaging these interventions for dissemination and scale up; or other identified TTA needs of the grantee.

Implement CDC-approved TTA plan and conduct continuous assessment of internal and external capacity needs and tailor activities and TTA providers as needed.

Target Population http://www.hhs.gov/ash/oah/oah-initiatives/for-grantees/program-guidance/Assets/tpp_packaging_guidance.pdf http://www.hhs.gov/ash/oah/oah-initiatives/for-grantees/program-guidance/Assets/tpp_packaging_guidance.pdf http://www.hhs.gov/ash/oah/oah-initiatives/for-grantees/program-guidance/Assets/tpp_packaging_guidance.pdf

The target population for this project are young men within the age range of 15-24 years who are at high risk for fathering a teen pregnancy (e.g., young men at risk of health disparities due to low socioeconomic status (SES), race/ethnicity [with respect to high pregnancy rates among female teens who are Black or African American, Hispanic or Latino, Native Hawaiian or other Pacific Islander, American Indian and Alaska Native], exposure to social determinants negatively affecting health [e.g., inadequate housing, lower educational attainment, stressful neighborhood environment, high community unemployment, etc.], being out of school [for young men under age 18], unemployment [for young men ages 18-24], living in foster care, homelessness, experiencing trauma or domestic violence, involvement with the criminal justice system, substance abuse).

Collaboration/Partnerships

Grantees are expected to develop a Study Team to fulfill the capacity needs for successfully completing the project (e.g., intervention developer collaborating with a clinic and/or youth-serving organization to develop and implement the intervention; partnering with a research firm to conduct the evaluation). Grantees will establish and partner with a community advisory board (CAB), which includes representation from the target population and target settings. Grantees will also collaborate closely with CDC.

To ensure that the intervention tested is a significant step forward for the field and that the intervention and the evaluation are of the highest quality and rigor, Component A and Component B grantees are expected to collaborate with one or more TTA providers (such as internal or external consultants, organizations) that have the expertise and ability to provide needed technical assistance and training related to the proposed project.

Evaluation/Performance Measurement

All funded grantees are expected to complete a rigorous evaluation designed to address the required elements outlined in the Evidence Review (http://tppevidencereview.aspe.hhs.gov/EvidencePrograms.aspx) (see Appendix A for a summary), and a qualitative evaluation. All funded grantees will collect and report on a common set of performance measures to assess program implementation and whether the program is observing intended program outcomes. Grantees should consider whether TTA is needed to successfully design and undertake any aspects of the evaluation, and include such activities in their TTA plan and related budget.

Translation Plan

All funded grantees are expected to prepare an intervention outcome-related manuscript for submission to a peer-reviewed journal and prepare a manuscript and/or report on the findings from the qualitative evaluation.

All grantees with efficacious interventions are expected to complete packaging of the intervention. Grantees may include TTA activities, if needed, for completion of intervention packaging.

Anticipated Timeline

Component A

0-6 months

Finalize training and technical assistance plan after consultation with CDC Finalize and pilot intervention materials Develop…