PKG00258269-instructions.pdf

DEPARTMENT OF

HEALTH AND HUMAN SERVICES

OFFICE OF THE

ASSISTANT SECRETARY FOR HEALTH

Office of Population Affairs

Funding Opportunity: FY2020 Teen Pregnancy Prevention (TPP) Tier 2, Phase II Rigorous Evaluation of Promising Interventions

Opportunity Number: PA-TP2-20-001

Application Due Date:

Friday, April 17, 2020 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

Office of the Assistant Secretary for Health / Office of Population Affairs

FUNDING OPPORTUNITY TITLE

FY2020 Teen Pregnancy Prevention (TPP) Tier 2, Phase II Rigorous Evaluation of Promising Interventions

ACTION

Notice

ANNOUNCEMENT TYPE

Competitive Cooperative Agreement

FUNDING OPPORTUNITY NUMBER

PA-TP2-20-001

CFDA NUMBER AND PROGRAM:

93.297 Teen Pregnancy Prevention

DATES

Application Deadline: Monday, April 17, 2020 by 6:00 PM Eastern.

Technical Assistance: Webinar Wednesday, February 19, 2020 at 2:30 PM Eastern.

EXECUTIVE SUMMARY

The Office of Population Affairs announces the availability of funds for Fiscal Year (FY)

2020 cooperative agreement awards under the authority of Division A, Title II of the Further

Consolidated Appropriations Act, 2020 (Public Law No. 116-94).

This notice solicits applications for the FY2020 Teen Pregnancy Prevention (TPP) Tier

2, Phase II Rigorous Evaluation of Promising Interventions (TPP Rigorous Evaluation). The goal of this Funding Opportunity Announcement (FOA) is to rigorously evaluate promising interventions that could contribute to adolescent optimal health, prevent teen pregnancy, and reduce sexually transmitted infection (STI) rates. The applicant is expected to evaluate interventions that already have project merit, positive preliminary evidence, readiness, and feasibility. This funding will support rigorous evaluations designed to answer important research question(s) about the impact and implementation of interventions. Projects may conduct either efficacy or effectiveness studies and must be able to complete the project within the three-year period. OPA intends to make approximately $5 million available for an estimated five to ten awards. The amount of funding an applicant may request ranges from $500,000 to $1 million per year for a three year period (three 12-month budget periods).

This FOA continues efforts supported through the FY2018 and FY2019 Phase I New and

Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence, but is open to any applicant (not just those previously funded through Phase I) who can meet the following expectations for Phase II.

1. Meaningfully Contribute to Optimal Health, Prevent Teen Pregnancy and Reduce

STIs; Demonstrate Project Merit and Preliminary Positive Evidence

2. Demonstrate Readiness and Feasibility of the Intervention and Evaluation

3. Conduct High-Quality Implementation

4. Rigorously Evaluate the Intervention

5. Collaborate with Partners, Participants, and Stakeholders

6. Monitor and Improve the Project

7. Communicate Project Activities; Disseminate Results

8. Manage the Project and Ensure Capacity

For purposes of this funding opportunity announcement, “project” will refer to all activities described in the grant application and funded by the grant; “evaluation” will refer to the rigorous implementation and impact research of interventions; “intervention” will refer to the innovative programs, models, component(s), products, approaches, or practices to prevent teen pregnancy and reduce STIs; and “counterfactual” will refer to the comparison or control group(s) in the evaluation.

FUNDING OPPORTUNITY DETAILS

A. DATES

1. Application Deadline

Your application is due Friday, April 17, 2020 by 6:00 PM Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a written exemption from this requirement 2 business days in advance of the deadline from the Director, HHS/Office of the Assistant Secretary for Health (OASH) Office of Grants Management (OGM).

To obtain an exemption, you must request one via email from the HHS/OASH OGM, and provide details as to why you are technologically unable to submit electronically through Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request: the HHS/OASH announcement number;

your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your Authorizing Official; the Grants.gov Tracking Number (for example, GRANT####) assigned to your submission; and a copy of the "Rejected with Errors" notification from Grants.gov. Send the request with supporting documentation to ogm.oash@hhs.gov. Note: failure to have an active System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. Failure to follow Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH OGM will only accept applications via alternate methods (hardcopy paper via U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval.

If you receive an exemption, you must still submit your application by the deadline. Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via U.S.

mail or other service or PDF via email) with an approved written exemption will be accepted. See

Section F.8 (“Other Submission Requirements”) for information on application submission mechanisms.

To ensure adequate time to submit your application successfully, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. You must register an authorizing official for your organization. HHS/OASH does not determine your organization’s authorizing official; your organization makes that designation. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov

Contact Center 24 hours a day, 7 days a week (excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

mailto:ogm.oash@hhs.gov http://www.grants.gov/ mailto:support@grants.gov

Your organization is strongly encouraged to register multiple authorized organization representatives in Grants.gov to ensure someone is available to submit your application.

2. Technical Assistance

A technical assistance webinar for potential applicants will be held on February 19, 2020, at 2:30 PM Eastern. Details to log-in to the webinar will be available on the OPA website at https://www.hhs.gov/opa/grants-and-funding/index.html.

We recommend you review the entire announcement promptly so you can have any questions answered well in advance of the application due date. We also recommend you subscribe to this announcement in Grants.gov so you receive any amendments, question and answer documents, or other updates.

B. PROGRAM DESCRIPTION:

The Office of the Assistant Secretary for Health, Office of Population Affairs announces the availability of funds for Fiscal Year (FY) 2020 cooperative agreement awards under the authority of Division A, Title II of the Further Consolidated Appropriations Act, 2020 (Public Law

No. 116-94). The primary focus of the Office of the Assistant Secretary for Health is leading

America to healthier lives, especially for those who are most vulnerable, including those who have suffered historic disparities. In support of this vision, the Office of Population Affairs promotes health across the reproductive lifespan through innovative, evidence-based adolescent health and family planning programs, services, strategic partnerships, evaluation, and research. The Teen

Pregnancy Prevention (TPP) Program is designed to give youth the information and skills to promote optimal health and prevent teen pregnancy across the United States, especially among those who are most vulnerable.

https://www.hhs.gov/opa/grants-and-funding/index.html

1. Background

There has been much progress in reducing teen pregnancy and teen birth. However, the current teen birth rate in 2018 of 17.4 per 1,000 females aged 15-19 is still much higher than other western industrialized nations [1,2], and we continue to see disparities by race, ethnicity, and among our most vulnerable populations, including homeless youth, those living in foster care, or involved with the juvenile justice system [2,3,4]. Further, STI rates reached an all-time high in the

United States in 2018 [5], with significant concern for transmission of STIs in adolescents. Syphilis rates jumped 34% from 2017 for females age 15-19. Approximately 62% of all chlamydia cases

(1,087,277) were reported in individuals aged 15-24, and 15-19-year-old males and females experienced an increase of 3.7% and 1.3%, respectively, from 2017. Females in this age group also reported the second-highest rate of gonorrhea, after females age 20-24. Herpes continues to be prevalent. Finally, while not as common in adolescents, individuals aged 13-24 made up 21% of all new HIV diagnoses in 2017 [6].

The Office of Population Affairs’ (OPA) goal is to ensure optimal health beginning in adolescence and continuing across the reproductive lifespan through lifestyle change. Optimal health is a dynamic balance of physical, emotional, social, spiritual, and intellectual health.

Lifestyle change can be facilitated through a combination of learning experiences that enhance awareness, increase motivation, and build skills and, most important, through the creation of opportunities that open access to environments that make positive health practices the easiest choice [7]. OPA takes an optimal health approach in supporting adolescents to lead healthier lives by avoiding and/or reducing sexual risks, preventing teen pregnancy, and reducing STIs. The optimal health model can be applied to a broad range of programs proven effective at preventing teen pregnancy and associated risk behaviors, including positive youth development, sex education, abstinence education, and programs designed for diverse populations and settings.

Under this framework, OPA also promotes healthy adolescence through the Adolescent Health:

Think, Act, Grow® (TAG) Five Essentials, including: positive connections with supportive people; safe and secure places to live, learn, work and play; access to high quality and teen-friendly health care; opportunities to engage as learners, leaders, team members, and workers; and coordinated adolescent and family-centered services.

New and innovative programs to prevent teen pregnancy and improve optimal health are being developed and evaluated through investments by the U.S. Department of Health and Human

Services and others. The Personal Responsibility Education Innovative Strategies Program

(PREIS) at ACF, for example, has funded research and demonstration projects that implement innovative strategies for preventing pregnancy among youth aged 10-19 years old. Through

OASH, in 2015, five-year investments were made to enable and support early innovation to advance adolescent health and prevent teen pregnancy (FY15 TPP Tier 2A); through this funding, new technologies and programs have been developed. At the same time, teen pregnancy prevention programs were funded to undergo rigorous evaluation (FY15 TPP Tier 2B). More recently, in

2018, OPA invested in Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence. These projects were funded for two years to conduct formative evaluations of new and innovative programs.

This FOA continues efforts supported through the FY2018 and FY2019 Phase I New and

Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence, but is open to any applicant (not just those previously funded through Phase I). The purpose of this

FOA is to rigorously evaluate interventions that already have project merit, positive preliminary evidence, readiness, and feasibility. All applicants are expected to justify that their intervention is ready for rigorous evaluation, and their rigorous evaluation would be ready to start within the first three months of the project period. Successful applicants will have fully developed and tested interventions, which show positive, preliminary evidence from their formative evaluation.

Formative evaluation results should show demand and need for the intervention, directly from participants. Additionally, successful applicants will demonstrate that intervention materials are already developed and tested, including all supporting materials such as training or intervention manuals. Furthermore, successful applicants will have their rigorous evaluation designed and evaluation tools available.

Although many programs have been developed and evaluated, there is still much to learn about what works, how, for whom, and why. Additionally, there is a lack of effective programs for key areas and populations that face health disparities. This funding will support rigorous evaluations designed to answer important research question(s) about the impact and implementation of interventions. Projects may conduct either efficacy or effectiveness studies and must be able to complete the project within the three-year period.

In order to ensure health equity and promote optimal health, OPA is particularly interested in rigorous evaluations of promising interventions in populations and settings with great need and those that demonstrate significant health disparities. This may include, but is not limited to, interventions in juvenile justice or foster care/child welfare settings, with expectant and parenting youth, youth with disabilities, with homeless youth, or for caregivers. Additionally, OPA is interested in projects that impact not only individuals but also the systems within which individuals are situated.

Applicants are expected to evaluate interventions that address key health disparities and have the potential to make a significant contribution to the field. All interventions proposed should already have project merit, positive, preliminary evidence, and readiness and feasibility for a rigorous evaluation. Successful projects will meet the following expectations for the FY 2020

Teen Pregnancy Prevention (TPP) Tier 2, Phase II Rigorous Evaluation of Promising

Interventions (TPP Rigorous Evaluation): (a) Meaningfully Contribute to Optimal Health, Prevent Teen Pregnancy, and Reduce STIs; Demonstrate Project Merit and Preliminary Positive

Evidence; (b) Demonstrate Readiness and Feasibility of the Intervention and Evaluation;

(c) Conduct High-Quality Implementation; (d) Rigorously Evaluate the Intervention;

(e) Collaborate with Partners, Participants, and Stakeholders; (f) Monitor and Improve the Project;

(g) Communicate Project Activities; Disseminate Results; and (h) Manage the Project and Ensure

Capacity.

2. Expectations

a. Meaningfully Contribute to Optimal Health, Prevent Teen Pregnancy, and

Reduce STIs; Demonstrate Project Merit and Preliminary Positive Evidence

Applicants are expected to meaningfully contribute and show how the project has the potential to improve optimal health, prevent teen pregnancy, and reduce STIs. OPA is especially interested in targeting resources to populations disproportionately impacted by teen pregnancy and

STI rates, to reduce health disparities and to improve equity and optimal health.

Interventions supported by this funding are expected to be innovative and already have compelling, positive preliminary evidence from their formative evaluation, including effects on target outcomes. The intervention should also have widespread support from participants and stakeholders and be a good fit for the target population and setting. In order to make a meaningful contribution, interventions evaluated under this funding are expected to have the potential to scale and be replicated by others. Applicants should demonstrate the potential for scale of the intervention upon project completion.

b. Demonstrate Readiness and Feasibility of the Intervention and Evaluation

1) Intervention Readiness and Feasibility

In addition to making a meaningful contribution, OPA expects applicants to have all intervention materials finalized, ready, accessible, and available for implementation. The intervention and supporting materials should be fully developed, and applicants or their partners should have implemented the intervention multiple times. Materials must also already be medically accurate and age-appropriate and should be trauma-informed and user-centered; changes to the intervention should have already been made based on participant feedback. Procedures and activities of the intervention are expected to be clear, including mode of delivery, frequency, duration, location, setting, and monitoring mechanisms. The applicant is expected to describe the procedures for intervention implementation and the training necessary for staff. Applicants are expected to ensure feasibility of implementation within their application but also throughout the project period. This includes but is not limited to a reasonable timeline and Memorandums of

Understand (MOUs) or other agreements with partners to begin at the start of the project period.

This information will also be covered in the “Conduct High-Quality Implementation” and

“Capacity and Project Management” expectation.

Applicants who choose to use any copyrighted curriculum materials in their proposed project must include a signed agreement with the developer or purveyor of the materials that demonstrates that the applicant has permission to use the materials as planned. This should include, but is not limited to, permission to use the materials as proposed in the application and/or alter them as needed for compliance with OPA medical accuracy review.

2) Evaluation Readiness and Feasibility

The evaluation is expected to be ready and feasible at the time of award, including clear plans for the counterfactual (comparison or control group); any services, programming, or materials proposed for the counterfactual group must be ready for implementation and accessible to the applicant by the time of grant award. Methods and procedures for participant recruitment, consent/assent, and study group formation should be reasonable and feasible for the proposed project and three-year timeline. All project activities, including data collection, data analysis, and reporting, are expected to be completed within three years, which includes dedicating the final six months to analysis and reporting. Applicants are expected to propose a sample size for their project that can detect impacts and account for attrition or other potential loss of data (see “Conduct

Rigorous Evaluation” expectation). Evaluation designs should include power calculations based on the proposed sample size; evaluation designs are expected to be sufficiently powered to detect impacts on the primary research questions. Applicants are expected to have IRB approval or a waiver by the start of the project period and be ready to begin their evaluation immediately upon receipt of funding. All MOUs or agreements between the applicant and their key implementation partners (such as implementation sites, independent evaluator, and program implementers) should be in place for the evaluation to begin immediately at the start of the project period. Applicants are expected to include all signed agreements in an Appendix (also see “Manage the Project and

Ensure Capacity” expectation).

c. Conduct High-Quality Implementation

It is expected that during the project, the awardee will conduct high-quality implementation of the intervention, including but not limited to: maintaining fidelity, quality assurance, high dosage, intervention saturation, appropriate materials, staff coordination and management, qualified facilitators, participant engagement and satisfaction, and stakeholder support. The applicant should describe the implementation settings, including partners and the status of agreements with partners. High-quality implementation should also be realized through adequate training and codified procedures for the intervention and, if applicable, the counterfactual. It is required that throughout the project, the implementation will be medically accurate and age-appropriate and expected that it will be trauma-informed and user-centered for both the intervention and counterfactual. Additionally, the awardee is expected to use implementation findings to improve the implementation and delivery.

Given that implementation and research is likely to occur in environments that have been historically under-resourced and marginalized, there is an expectation to appropriately understand the context and big picture in which the issues of teen pregnancy and STIs exist. Systems thinking can help applicants demonstrate an understanding of contextual factors, relationships between those factors, and how things can change over time. The applicant should explain an understanding of the context, big picture, and how their intervention and research is situated. Additionally, the applicant should explain underlying assumptions and inhibiting or enabling factors related to the project. Awardees, throughout their projects, are expected to adequately consider the complexity of the implementation environment.

d. Conduct Rigorous Evaluation

Rigorous evaluations can include either a randomized control trial (RCT) or a quasi-experimental design (QED) with counterfactual condition, and should be the most robust possible design that is feasible for the intervention. RCTs are experiments that randomly assign participants into different, unique groups: the treatment or intervention group and the control or counterfactual.

A QED forms intervention and counterfactual groups through methods other than random assignment of participants. A QED may be used for impact evaluations when random assignment is not an option and include methods such as Propensity Score Matching (PSM), Regression

Discontinuity, and Interrupted Time Series (ITS), among others.

Evaluations supported by this funding can be an efficacy or effectiveness study. Efficacy studies evaluate interventions under ideal conditions, often with the close involvement of the intervention developer, whereas effectiveness studies evaluate an intervention during routine or natural conditions [8]. Applicants are also expected to conduct an implementation evaluation, based on implementation science practices and designed to answer questions about how and why an intervention works.

Applicants are expected to describe the type of design selected and if it is an efficacy or effectiveness trial. They should describe the full study design, including the implementation and impact evaluation. Research questions are expected to assess both behaviors and implementation outcomes and clearly align with the intervention and theory of change. Primary and secondary questions should be determined, and evaluation designs are expected to be sufficiently well-powered to detect impacts for the primary research question(s) (80 percent chance of being statistically significant at the p<.05 level). OPA expects that all studies will have a counterfactual, and there will be baseline equivalency between the intervention group and counterfactual.

Additionally, it is expected for the treatment and counterfactual groups to be different enough to allow for a meaningful test. For RCTs, the unit of random assignment is expected to be clearly identified and aligned with the unit of analysis; for QEDs, the applicant is expected to describe the formation of the counterfactual. Differences between groups should be described along with strategies to minimize potential contamination, should this be a potential concern.

The applicant is expected to have data collection instruments that have already been tested or administrative data which can be accessed. The applicant is expected to describe how they plan to estimate the causal impact of the intervention, describe the minimum detectable effect (MDE) size needed for an impact, and explain how the MDE was calculated. Awardees will collect, analyze, and report on the data, providing updates to key stakeholders regularly.

Awardees are expected to be aware of and address limitations, bias, and possible threats to internal and external validity. The evaluation is expected to be conducted through a credible and neutral process, which includes, at a minimum, evaluation staff who do not have perceived or actual conflict of interest and can remain independent from the intervention (see “Manage the

Project and Ensure Capacity” section). As a condition of the grant award, recipients will be required to participate in Evaluation Technical Assistance from OPA. Further, as a condition of the grant award, all successful recipients will be required to participate in any OPA-directed

Federal evaluation, if selected, and if funding for such an evaluation becomes available. Recipients will be expected to submit a final evaluation report to OPA at the end of the grant award; specific guidance on the format will be provided after the grant is awarded.

e. Collaborate with Partners, Participants, and Stakeholders

Given the purpose of the funding to improve optimal health of youth, prevent teen pregnancy, and reduce STIs rates, it is important to collaborate and maintain partnerships with those involved in the project, including partners, participants, and stakeholders. OPA expects that applicants will demonstrate how they have previously engaged participants and stakeholders, maintained a collaborative environment, and structured their approach accordingly. Additionally, OPA does not expect one organization to carry out the entire project; rather, the applicant and their key partners should have the collective expertise necessary to successfully accomplish the goals and objectives for the implementation and evaluation. Collaborative partnership is expected between the evaluator and intervention teams, and with OPA. The awardee is responsible for ensuring all partners meet the expectations successfully and fulfill their roles.

f. Monitor and Improve the Project

OPA expects awardees to monitor the overall project and, based on key findings, make improvements to the project. This could include improvements to the evaluation or implementation procedures, for example. The monitoring and improvement plan should include performance measures for the overall project. Furthermore, awardees will use the information garnered from the evaluation, monitoring, and performance measures to determine next steps for the intervention and project. This could include positioning the intervention for widespread dissemination and scale, or it could include changing the design of the intervention based on findings and preparing for another type of evaluation.

All recipients are expected to collect a common set of performance measures to assess project implementation and use measures for monitoring and improving. See Appendix C for a draft set of performance measures (subject to change). Recipients must collect all performance measures and report to OAH on a semi-annual basis. Recipients should review relevant state laws, organizational policies, and other administrative procedures of their sites or partner organizations to ensure the feasibility of data collection. Recipients should obtain any necessary permissions to collect required data.

g. Communicate Project Activities and Disseminate Results

Communicating information is vitally important to project success, sustainability, and to stakeholders. The public, internal stakeholders, and external stakeholders should be informed about the activities of the project throughout the entire project period. Additionally, OPA expects recipients to carefully document the results of the intervention, using best practices for reporting such as the CONsolidated Standards of Reporting Trials (CONSORT) for RCTs [9] or the

Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) for QEDs [10].

Recipients are expected to present results at local, state, and national professional and academic conferences and meetings, and to share findings in respected journals or other publications and

OPA reports.

h. Manage the Project and Ensure Capacity

The applicant should propose a team, partnerships, and structure to successfully accomplish all expectations of the grant. OPA expects the applicant to provide an overview of the different organizations involved, along with key team members. Key team members should have resumes with credentials, expertise, and capacity that align with their positions. The applicant, in particular, should clearly articulate who will serve as the evaluation and intervention leads and include the resumes with relevant experience. The project should be conducted through a credible and neutral process, which includes, at a minimum, evaluation staff who do not have perceived or actual conflict of interest and can remain independent from the intervention.

A visual depiction of the project structure, including key partners and roles, should be included. The applicant should outline how they plan to manage the project. For all partnerships, the application should include a signed Memorandum of Understanding (MOU) that describes how the partner will contribute to the project and clearly outlines roles, responsibilities, and expectations. Awardees should assess the professional development needs of staff on a regular basis and use the results to develop a plan for providing ongoing professional development and support for staff.

Awardees may use up to the first three months to complete project planning and finalize agreements. However, this funding is designed to support projects that are ready, feasible, already have project merit, and demonstrate positive preliminary results.

This award is a cooperative agreement, a form of assistance that allows for substantial involvement by OPA. In addition to the usual monitoring and technical assistance provided under the cooperative agreement (e.g., assistance from assigned Federal project officer, regular conference calls, occasional site visits, ongoing review of plans and progress, participation in relevant meetings, provision of training and technical assistance), OPA’s substantial programmatic involvement will include:

1) Prior approval for change of time that Key Personnel are dedicated to the project and for replacement of Key Personnel. Key Personnel are those staff that are responsible for the day-to-day project management as well as the lead evaluator.

2) Identification of other awardees and organizations with whom the awardee may be asked to develop cooperative and collaborative relationships and partnerships.

3) Assisting the awardee to establish, review, and update priorities for activities conducted under the auspices of this cooperative agreement.

4) Consulting with the awardee throughout the preparation and dissemination of materials related to the project.

5) Review and approval of implementation plans, evaluation plans, data collection tools and measures, and monitoring plans.

6) Ensuring intervention materials prior to use in the project are medically-accurate, age-appropriate, trauma-informed, and user-centered.

C. AUTHORITY

Division A, Title II of the Further Consolidated Appropriations Act, 2020 (Public Law No.

116-94).

D. FEDERAL AWARD INFORMATION

The Office of Population Affairs intends to make funds available for competing cooperative agreements.

We will fund awards in annual increments (budget periods) and generally for a project period up to 3 year, although we may approve shorter project periods. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors. Funding for all approved budget periods beyond the first is generally level with the initial award amount and is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds.

Award Information

Estimated Federal Funds Available: $5,000,000

Anticipated Number of Awards: 5-10

Award Ceiling (Federal Funds including indirect costs): $1,000,000 per budget period

Award Floor (Federal Funds including indirect costs):$500,000 per budget period

Anticipated Start Date: July 15, 2020

Estimated Period of Performance: Not to exceed 3 years

Anticipated Initial Budget Period Length: 12 months

Type of Award: Cooperative Agreement. Agency substantial involvement outlined above in Program Description.

Type of Application Accepted: Electronic via Grants.gov ONLY unless an exemption is granted

E. ELIGIBILITY INFORMATION

1. Eligible Applicants.

Any public or private entity, including faith-based, community-based, and Indian Tribes or

Tribal organizations are eligible to apply.

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget

3. Other Eligibility Information

None

4. Application Disqualification Criteria

If you successfully submit an application, we will screen it to ensure it meets the below requirements. If we determine your application fails to meet the criteria described below we will disqualify it, that is, we will not review it and will give it no further consideration.

(a) You must submit your application electronically via www.grants.gov

(unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the DATES section (A.1) of this announcement.

(b) If you successfully submit multiple applications from the same organization for the same project, we will only review the last application received by the deadline.

(c) HHS/OASH/OGM deems your application eligible according to section

E.1 Eligible Applicants.

(d) You must complete the required forms in the application package: SF-424, SF-424A, SF-424B, SF-LLL, and Project Abstract Summary.

(e) Your Project Narrative section of the application must be double-spaced, on the equivalent of 8 ½ ” x 11” inch page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points.

(f) Your Project Narrative must not exceed 50 pages. NOTE: The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and

Budget Narrative (including budget tables).

(g) Your total application, including the Project Narrative plus Appendices, must not exceed 100 pages. NOTE: the items listed in “(f)” immediately above that do not count toward total page limit.

(h) Your Federal funds request including indirect costs must not exceed the maximum indicated in Award Ceiling.

(i) Your Federal funds request including indirect costs must not be below the minimum indicated in Award Floor.

F. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/. You can find it by searching on the CFDA number shown on page 2 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

Office of Grants Management

Phone: 240-453-8822

Email: ogm.oash@hhs.gov

2. Content and Form of Application Submission

a. Application Format

Your application must be prepared using the forms and information provided in the online application package.

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section C. The page limit does not mailto:ogm.oash@hhs.gov include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria. Please do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete. If your application exceeds the specified page limits for the Project

Narrative or Project Narrative plus Appendices when printed on 8.5” X 11” paper by

HHS/OASH/OGM, we will not review it. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

You must double-space the Project Narrative pages.

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

b. Appendices Format

Your Appendices should include any specific documents outlined in Section D.2.iii., under the heading “Appendices” in the Application Content section of this funding opportunity announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative. However, documents such as résumés/CVs, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. All of your appendices must be uploaded as a single, consolidated file in the Attachments section of your Grants.gov application.

c. Project Abstract Summary Format

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents. If your project is funded, HHS may publish information from your form; therefore, do not include sensitive or proprietary information.

Summarize your project in 250 words; outline the project’s name, intervention, setting, and target population; explain the project, structure, evaluation design, and expected contribution.

d. Budget Narrative Format

The Budget Narrative should use the formatting required of the Project Narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily-readable format and within the printable margins of the page.

3. Application Content

Successful applications will contain the following information:

a. Project Narrative Content

1) Project Merit, Contribution, and Evidence

• What is the specific problem that your project addresses? What is the context for this project? Where will the project take place, and with whom? How will you address historical, structural, and environmental factors that could impact your project? What are your underlying assumptions for this project?

• In brief, what are your intervention, theory of change, and evaluation design?

• How do your project, intervention, and evaluation contribute to the field? Why is this project important?

• How does your intervention meet the needs of your participants? How is it innovative? How is it a good fit for the population? Please verify with supporting evidence directly from your participants.

• What previous research has been conducted? How does this evaluation build from the previous research? Why is your specific evaluation necessary to conduct?

• What is the preliminary evidence of effectiveness for the intervention?

Were there positive effects on key outcomes?

• How many times has the intervention been implemented already? What were the circumstances, and how has it evolved?

• Could this intervention, if proven impactful, scale and be replicated by others? How? What key barriers might you face?

2) Technical Approach

(a) Intervention and Theory of Change

• How is your intervention and theory of change ready for an evaluation?

What is the status of your intervention materials, supplemental materials such as trainings and staff requirements? Please demonstrate and justify that materials are accessible, available, final, and already trauma-informed, medically-accurate, age-appropriate, and user-centered.

• Please include a visual depiction of your theory of change as an appendix.

(b) Counterfactual

• What is your counterfactual? What curriculum, materials, or services, if any, will the counterfactual group receive, and who will provide the programming to the counterfactual participants? Indicate whether a business-as-usual (BAU) counterfactual is planned. Are the proposed counterfactual materials/services, trainings, staff requirements ready for implementation, and available by the start of the grant project? Please demonstrate, if applicable, counterfactual materials are accessible, available, final, and already trauma-informed, medically-accurate, age-appropriate, and user-centered.

• How will your project ensure contrast between the intervention and the counterfactual groups? How will you assess the extent of diffusion of the program to the intervention group and counterfactual? What is your plan for assessing whether the counterfactual group received programming or BAU?

(c) Implementation

• During the project period, how will you implement the intervention?

Why? Has this been conducted before, and did it work? What benchmarks and monitoring tools do you have for successful implementation?

• Do you have final, signed MOUs with all implementation partners that show that implementation is ready to begin immediately upon receipt of funding?

(d) Evaluation Plan

• What is your evaluation design (i.e., randomized control trial, quasi-experimental design)? Will you be conducting an efficacy or effectiveness study? How did you use the most robust possible design?

Please justify

• What are the primary and secondary research questions or hypotheses you are testing? How will your questions assess both impact and implementation evaluation? Ensure research questions are phrased such that groups can be compared to understand the net effect of intervention and differences. Additionally, ensure the confirmatory research question(s) represent(s) the main impact question(s) for the primary outcome that the study can address with a known level of statistical precision (based on statistical power).

• How will the counterfactual group(s) be formed or assigned? Please describe strategies to minimize potential contamination (if this is a potential concern). If applicable, include recruitment, consent, assignment, tracking, and retaining methods.

• What outcomes are you measuring? Why? What implementation factors are you measuring? Why? How does this relate back to your theory of change? What data will be collected to support the impact evaluation and implementation evaluation? Describe how existing data collection instruments or data sources align with the research questions, evaluation, intervention, and theory of change?

• What systems, procedures, and processes will you use to collect data?

Why?

• Estimate the statistical power. Describe whether statistical power is consistent with the study design, has an 80 percent chance of being statistically significant at the p<.05 level, and includes additional power analyses for plans to analyze subgroups.

• What are your plans for measuring the level of services actually received by participants? How will you assess if an adequate amount of the intervention was delivered to participants? How will you measure quality of the intervention delivery?

• How will you estimate causal impact of the intervention? What is your minimum detectable effect (MDE) size? What is your sample size and power for detecting an impact?

• What limitations are there? What potential bias is there in your plan?

What possible threats are there to internal and external validity? How will these be addressed?

(e) Readiness and Feasibility of Rigorous Evaluation

• What is the status of your IRB approval?

• What data instruments will be used, and have they been developed and tested already? If using administrative data, where will you acquire this data, and have you already received permission?

• Do you have agreements in place with all external partners (such as implementation sites, independent evaluator, and program implementers if applicable) to conduct the evaluation? Verify with

MOUs or agreements

• Can the evaluation successfully be completed within three years? Will follow up data collection end by December 2022 to allow enough time for analysis? Include a timeline to show key activities during the project period.

(f) Monitor and Improve the Project

• How will you monitor the project overall? What will you monitor, and why? What will be the frequency of monitoring activities?

• How will you use data, including required TPP performance measures, to improve the project? What is your process for improving the project overall?

(g) Collaboration, Communication, and Dissemination

• How will the project work with partners, participants, and stakeholders to maintain a collaborative environment? How will the project equitably engage participants from the target population? What about key stakeholders from the community?

• What is the communication plan for the project overall? How will you apply best practices to disseminate results, including to participants and stakeholders?

3) Project Management and Capacity

• Please provide an overview of the implementing and evaluating organization, along with the organizational structure of the project. How will the project be managed?

• Who are the partners (if any), what skills and expertise do they contribute, and how will they be monitored? Please attach finalized

MOUs and agreements and indicate the status of agreements that have not been finalized.

• Who are the key team members? Does the lead evaluator have experience receiving IRB approval, conducting rigorous evaluation, and publishing results? Does the implementation staff have experience with the target population and the intervention?

• Provide a brief summary list, and include training, qualifications, and experience with similar projects and target populations. In addition, provide resumes for leadership members, such as lead evaluator(s) and lead interventionist(s).

• Are there any perceived or actual conflicts of interest? How will you ensure neutrality and independence between the evaluation and intervention?

b. Budget Narrative Content

You must complete the required budget forms and submit a budget narrative with detailed justification as part of your application. You must enter the project budget on the Budget

Information Non-construction Programs standard form (SF 424A) according to the directions provided with this standard form. The budget narrative consists of a detailed line-item budget that includes calculations for all costs and activities by "object class categories" identified on the SF-

424A and justification of the costs. You must indicate the method you are selecting for your indirect cost rate. See Indirect Costs below for further information.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. If matching or cost sharing is required, you must include a detailed listing of any funding sources identified in box 18 of the SF-

424 (Application for Federal Assistance).

Please be sure to carefully review section F.7 Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

You must provide an object class category budget using Section B, box 6 of the SF 424A for the first year of the proposed project. Provide a budget justification, which includes explanatory text and line-item detail, for the first year of the proposed project. The budget narrative should describe how the categorical costs are derived. Discuss the necessity, reasonableness, and allocation of the proposed costs.

For subsequent budget years, provide a summary narrative and line item budget. For categories or items that differ significantly from the first budget year, provide a detailed justification explaining these changes. Note, do not include costs beyond the first budget year in the object class budget in box 6 of the SF- 424A or box 18 of the SF-424; the amounts entered in these sections should only reflect the first budget year.

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. For example, if you are proposing to provide services to clients, you should describe how many clients are you expecting to serve, the unit cost of serving each client, and how this is cost effective.

Use the following guidelines for preparing the detailed object class budget required by box

6 of the SF-424A. The object class budget organizes your proposed costs into a set of defined categories outlined below. Both federal and non-federal resources (when required) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying. "Non-federal resources" are all other non-HHS/OASH federal and non-federal resources. We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested;

third column, non-federal resources; and last column, total budget.

Sample Budget Table

Object Class Federal Funds

Requested

Non-federal

Resources

Total Budget

Personnel $100,000 $25,000 $125,000

Note, subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items, i.e., subrecipient travel should be included in the Contractual line item not in Travel.

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