FOA PS17-004.pdf

Centers for Disease Control

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program

Office

Evaluation of Models of PrEP Service Delivery at Title X and STD Clinics

RFA-PS-17-004

Application Due Date: 01/17/2017

Evaluation of Models of PrEP Service Delivery at Title X and STD Clinics

RFA-PS-17-004

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 Components of Participating Organizations National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office (NCHHSTP ERPO) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Funding Opportunity Announcement (FOA) Title Evaluation of Models of PrEP Service Delivery at Title X and STD Clinics Activity Code U01 Research Project - Cooperative Agreement

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-PS-17-004

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.941 93.974 Category of Funding Activity:

Health FOA Purpose To evaluate the effectiveness and cost of three health services models of PrEP provision at Title X and sexually transmitted disease (STD) clinics located in communities with high rates of new HIV diagnoses.

Model 1: PrEP services provided in the Title X or STD clinic. Model 2: Referral to a PrEP service provider in the community. Model 3: Navigator-assisted linkage to a PrEP service provider in the community.

Participating Organizations:

Centers for Disease Control and Prevention (CDC) http://www.cdc.gov/

Office of the Assistant Secretary for Health (OASH) http://www.hhs.gov/ash/

Components of Participating Organizations:

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP/CDC) http://www .cdc.gov/nchhstp/Default.htm

Office of Population Affairs (OPA/OASH) http://www.hhs.gov/opa/

Key Dates Publication Date: To receive notification of any changes to RFA-PS-17-004, return to the http://www.cdc.gov/ http://www.hhs.gov/ash/ http://www.cdc.gov/nchhstp/Default.htm http://www.cdc.gov/nchhstp/Default.htm http://www.hhs.gov/opa/

Publication Date: To receive notification of any changes to RFA-PS-17-004, 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: 12/14/2016

Application Due Date: 01/17/2017

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: 02/21/2017

Secondary Review: 03/22/2017

Estimated Start Date: 07/01/2017

Expiration Date: 01/18/2017 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

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: To evaluate the effectiveness and cost of three health services models of preexposure prophylaxis (PrEP) provision at Title X and STD clinics located in communities with high rates of new HIV diagnoses. Model 1: PrEP services provided in the Title X or STD clinic. Model 2: Referral to a PrEP service provider in the community. Model 3: Navigator-assisted linkage to a PrEP service provider in the community.

Mechanism of Support: Research Project - Cooperative Agreement (U01) Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 4-year project period is $11,000,000. The estimated number of awards is one (1). Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $2,000,000 with individual awards ranging from $1,500,000 to $2,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $11,000,000. The project period is anticipated to run from 07/01/17 to 06/30/21.

http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf period is $11,000,000. The project period is anticipated to run from 07/01/17 to 06/30/21.

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 of this announcement 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. There will only be one PD/PI for each application.

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

Application Type. New.

Special Date(s). Not applicable.

Application Materials. See Section IV.1 for application materials. Please note that Form D Research is to be used when downloading the application package. http://grants.nih.gov/grants/how-to-apply -application-guide/forms-d/general-forms-d.pdf Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

1-888-232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Sections 301 and 318 of the Public Health Service Act [42 U.S.C. Sections 241 and 247(c)], as amended.

Section 1004 [42 U.S.C. §300a-2] of the Public Health Service Act.

1. Background and Purpose Pre-exposure prophylaxis (PrEP) is the administration of a once daily pill (Truvada®) to reduce the risk for HIV acquisition. PrEP has been demonstrated to be a safe and highly effective HIV prevention strategy.

In recent years, the rate of new HIV diagnoses has remained stable in the United States. However, rates remain high among certain populations such as gay, bisexual, and other men who have sex with men (MSM) and persons who are black or African American. In addition, women accounted for 19% of new diagnoses in 2014. It is especially important to target young MSM and women in at-risk populations for HIV with linkage to HIV prevention and care services in order to ensure early, effective treatment for infection and to prevent new infections.

Title X clinics and STD clinics are ideal venues to identify persons at substantial risk of HIV acquisition, many of whom utilize sexual healthcare in these settings and could likely benefit from PrEP. It is estimated that in 2014, there were approximately as many heterosexual women (468,000) as MSM (492,000) with indications for PrEP in the United States. Although PrEP uptake remains low overall, it is particularly low among eligible women (Bush et al., ASM/ICAAC, 2016 http://www.natap.org/2016/HIV/062216_02.htm).

Women seeking care at Title X clinics are likely at higher risk of HIV acquisition than patients seen in other clinical settings, such as primary care. In 2015, 90% of the 4.0 million patients seen at Title X clinics were women, 66% had incomes at or below the federal poverty line, 67% were below the age of 30, 47% were non-white, and 32% were Hispanic. Approximately 1.8 million women were tested for chlamydia at Title X clinics in 2015, 1.9 million were tested for gonorrhea, and 444,000 were tested for syphilis. During that same year, 1.1 million men and women were tested for HIV at Title X clinics, of which 2,423 were positive (0.22%).

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://www.natap.org/2016/HIV/062216_02.htm

(0.22%).

In a recent study of persons who sought care in publicly-funded, urban STD clinics, among male patients, 49% were black, 21% were Hispanic, and 24% were MSM. Among female patients, 57% were black and 19% Hispanic. This study also found that 50% of persons seeking care in public STD clinics were uninsured, underscoring the importance of STD clinics as safety net providers for HIV testing and prevention services.

STDs are important markers of behaviors that place individuals at increased risk for HIV acquisition. In New York City, among MSM without rectal gonorrhea or chlamydial infection, the annual HIV incidence was 2.5%, compared with 6.7% (more than 150% greater) among those diagnosed with rectal gonorrhea or chlamydial infections. In Florida, among women without a bacterial STD, the overall HIV diagnosis rate was 30 per 100,000 person years compared with 598 per 100,000 (more than 19 times higher) for women diagnosed with syphilis and 171 per 100,000 (more than 5 times higher) for women diagnosed with gonorrhea.

The United States Preventive Services Task Force and CDC recommend routine HIV testing for adults and adolescents. HIV testing is also recommended as part of routine prenatal care; however, between 15 to 16% of U.S. women are childless by age 40 and would not benefit from prenatal testing. For these women, and other populations at risk for HIV, an encounter in the Title X or STD clinic is a valuable opportunity to provide HIV testing. HIV testing then serves as a decision node for linkage to HIV care services for those who test positive, or risk assessment with PrEP as a prevention option for those who test negative.

Health Equity:

The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy available at https://www.whitehouse.gov/administration/eop/onap/nhas.

Health disparity is a particular type of health difference that is closely linked with social or economic disadvantage based on racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion [HP 2020 - http://www.healthypeople.gov/2010/hp2020 /advisory/PhaseI/glossary.htm]. Health disparities in HIV, viral hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases.

Social determinants are the economic and social conditions that influence the health of individuals, communities and jurisdictions and include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion.

Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and Continuous efforts to maintain a desired state of equity after particular health disparities are eliminated.

Programs should use data, including social determinants data, to identify communities within their jurisdiction that are disproportionately affected by HIV, viral hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Healthy People 2020 and other National Strategic Priorities https://www.whitehouse.gov/administration/eop/onap/nhas http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm

This evaluation is designed to identify effective methods to increase access to, and use of, clinical HIV prevention services and aligns with the following strategic priorities:

Healthy People 2020 goals: Reduce New Infections (HIV-2, HIV-3); Increase HIV Testing and Prevent Risk (HIV-9, HIV-13, HIV-14, HIV-18).

National HIV/AIDS Strategy: Goal 1 [Reducing New HIV Infections]; Goal 3 [Reducing HIV-related Disparities and Health Inequities].

CDC Winnable Battles Goal: Reduce HIV infections.

Public Health Impact Developing best practices for implementing PrEP in Title X and STD clinics clinics will increase access to important HIV prevention clinical services for populations at substantial risk of acquiring HIV. Models will demonstrate best practices to link at-risk individuals to PrEP services and care.

Relevant Work

1. U.S. Public Health Service. Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States- 2014, a Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

2. National HIV/AIDS Strategy. Office of National AIDS Policy. 2015. https://www.aids.gov/federal-resou rces/national-hiv-aids-strategy/nhas-update.pdf

3. Hall H. I., Song R., Rhodes P., Prejean J., An Q., et al. Estimation of HIV incidence in the United States.

JAMA 2008;300:520-9.

4. CDC HIV Surveillance Report, 2014. (Accessed December 15, 2015, at http://www.cdc.gov/hiv/pdf/libra ry/reports/surveillance/cdc-hiv-surveillance-report-us.pdf)

5. Hoover K.W., Parsell B.W., Leichliter J.S., Habel M.A., Tao G., et al. Continuing need for sexually transmitted disease clinics after the affordable care act. AJPH 2015;105.

6. Fowler, C. I., Gable, J., Wang, J., and Lasater, B. (2015, August). Family Planning Annual Report: 2014 National Summary. Research Triangle Park, NC: RTI International.

7. Martinez G., Daniels K., Chandra A. Fertility of Men and Women Aged 15-44 in the United States:

National Survey of Family Growth, 2006-2010. National Health Statistics Reports 2012; 51: 1-27.

8. Monte L.M., Ellis R.R. Fertility of Women in the United States: 2012. U.S. Census Bureau, Current Population Survey 2014.

9. Pathela P., Braunstein S. L., Blank S., Schillinger J. A. HIV incidence among men with and those without sexually transmitted rectal infections: estimates from matching against an HIV case registry. Clin Infect Dis 2013;57:1203-9.

10. Peterman T. A., Newman D. R., Maddox L., Schmitt K., Shiver S. Risk for HIV following a diagnosis of syphilis, gonorrhea or chlamydia: 328,456 women in Florida, 2000-2011. Int J STD AIDS 2015;26:113-9.

11. Smith D.K., Van Handel M., Wolitski R.J., Stryker J.E., Hall H.I., et al. Estimated Percentages and Numbers of Adults with Indications for Pre-exposure Prophylaxis to Prevent HIV Acquisition — United States, 2015. MMWR 2015; 64:1291-1295.

2. Approach Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

Objectives/Outcomes http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf http://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-us.pdf http://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-us.pdf

The objective of this health services research evaluation is to compare models of PrEP service delivery in order to identify best practices for successful PrEP service delivery and improve PrEP uptake among persons at substantial risk of HIV acquisition.

PrEP service delivery models

The application will describe a strategy to implement and evaluate three PrEP service delivery models (below) in Title X and STD clinic settings. The application will describe the selection of at least three Title X and at least three STD clinics in which PrEP services will be provided. Clinics should be located in geographically diverse areas and reach underserved populations at substantial risk of acquiring HIV as defined by the 2014 PrEP guidelines (http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf ) and serving an at least 50% minority population.

Applications should include a brief description of each clinic, including the clinic type location, a description of the population typically served by the clinic, the number of patients seen each month, the estimated number of PrEP-eligible patients, and what (if any) PrEP services are offered. Clinics are not required to have historically-provided PrEP services. Applications should describe a plan to provide appropriate technical assistance to clinics and other partners that will be providing clinical, laboratory, counseling, and patient navigation services in order to introduce or scale up PrEP services in clinics including, but not limited to:

screening, navigation, and PrEP clinical management; billing for HIV testing and PrEP services; and assisting patients in enrolling in insurance and applying for PrEP assistance.

Model 1: Direct PrEP provision in Title X and STD clinics: Clinical providers will implement PrEP screening tools to identify individuals attending the clinic who are at substantial risk for HIV acquisition and potentially eligible for PrEP. Once identified, clinical providers at the Title X or STD clinic will offer PrEP, prescribe PrEP, and conduct all necessary counseling and navigation services and PrEP follow up appointments.

Model 2: Passive referral to external PrEP service provider(s): Clinical providers will implement PrEP screening tools to identify individuals attending the clinic who are at substantial risk for HIV acquisition who would benefit from PrEP. Once identified, clinic staff will refer patients to local clinical partner(s) that provide PrEP services, such as a Federally Qualified Health Center (FQHC), http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf primary care center, or infectious disease clinic/HIV specialist, where clinical management will take place.

Model 3: Active linkage to external PrEP service provider(s): As in Model 2, clinical providers will implement PrEP screening tools to identify individuals attending the clinic who are at substantial risk for HIV acquisition who would benefit from PrEP. Once identified, clinic staff will refer patients to local clinical partner(s) that provide PrEP services, such as a FQHC, primary care center, or infectious disease clinic/HIV specialist where clinical management will take place. In addition, patient navigators will be employed to assist patients with linkage to the PrEP provider and PrEP initiation. Navigation services should, at a minimum, support patients through PrEP initiation but may also extend beyond initiation to provide further support for PrEP adherence and retention. Services provided by the patient navigators may include scheduling the first PrEP appointment, providing reminders for the first PrEP appointment and subsequent appointments, and providing support services such as assistance with health insurance enrollment.

All models should include appropriate risk reduction counseling to all persons testing for HIV, referral to appropriate HIV and STD treatment services for persons testing positive for HIV or an STD, and clinic billing for PrEP and PrEP-related services. At all sites, existing resources should be leveraged to pay for clinical and lab services to ensure PrEP service delivery models can be sustained beyond the evaluation period.

Target Population The target population includes men and women, ages 18 years and older, attending Title X or STD clinics who are at substantial risk of HIV acquisition, as defined by the 2014 US Public Health Service PrEP guidelines (http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf ). At least 50% of the individuals receiving services under this cooperative agreement must be from ethnic and/or racial minority groups. Applications should describe the use of appropriate epidemiologic data to identify clinics that primarily serve populations with a high rate of new HIV diagnoses.

All applications should describe the design of models of HIV prevention that are accessible and available to persons regardless of age, gender, race, ethnicity, sexual orientation, gender identity, or socio-economic status. Additionally, all activities should result in measurable improvements in HIV prevention among the target population of underserved subpopulations of MSM of color, including but not limited to individuals with disabilities, and individuals with limited English proficiency.

Collaboration/Partnerships CDC/NCHHSTP (http://www.cdc.gov/nchhstp/Default.htm) and OASH/OPA (http://www.hhs.gov/opa/) are participating organizations/components of participating organizations for this FOA.

Required partnerships:

External PrEP provider(s) to whom PrEP-eligible patients at Title X and STD clinics can be referred. In order to maximize choice for referred patients, collaborations should be developed with multiple PrEP providers whenever possible. Collaborations should include data sharing agreements to ensure appropriate evaluation data can be collected for referred patients.

A healthcare organization, health department, or laboratory, to provide necessary clinical and laboratory data to evaluate the health service models; including at least three Title X clinics and at least three STD clinics.

Clinics who will be providing PrEP services.

Evidence of collaboration with the required partners must be provided in the application via letters of support from the collaborating partners. Place letters in the Letters of Support section of the PHS 398 Research Plan section of the FOA.

In addition, where appropriate, awardees should collaborate with other CDC-funded programs to apply lessons learned for quality PrEP care and other HIV prevention and care services.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a four-year research project period. The grantee will establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan, and develop and implement project performance measures that are based on specific programmatic objectives.

Also, funded PIs must submit an annual progress report showing activities and outcomes based on their overall research goals and timeline.

The primary evaluation outcome is the number and percent of PrEP-eligible patients initiated on PrEP.

Additional outcomes include:

http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf http://www.cdc.gov/nchhstp/Default.htm http://www.hhs.gov/opa/

Additional outcomes include:

1. PrEP screening and initiation outcomes, including:

Number of patients seen at the clinic Number of HIV tests performed Number of persons provided with risk reduction counseling Number of persons screened for PrEP indications Number of persons eligible for PrEP Number of persons referred to PrEP services Number of persons initiated on PrEP provided with recommended laboratory testing (e.g., HIV, hepatitis B, STDs, creatinine) Number of persons provided with PrEP adherence counseling Number of persons enrolled in health insurance/Medicaid (among uninsured) Number of persons enrolled in payment assistance plan Number of persons initiated on PrEP

2. Ongoing PrEP outcomes among persons enrolled in PrEP, including:

Number of persons attending scheduled follow up visits Number of persons provided with PrEP adherence counseling at follow-up visits Number of persons provided with HIV and STD risk reduction counseling at follow-up visits Number of persons provided with recommended laboratory testing (e.g., HIV, hepatitis B, STDs, creatinine) at follow-up visits Number of persons requiring and provided with health insurance assistance at follow up visits

3. PrEP patient health and behavioral outcomes, including:

Number of new HIV infections Number of incident STD infections (syphilis, gonorrhea, and chlamydia, hepatitis C, hepatitis B) Risk behavior

4. Cost of PrEP service delivery models

5. Patient and provider satisfaction

6. Documentation of lessons learned

Applications should clearly describe a research strategy to: (1) evaluate outcomes for the three models in Title X and STD clinical settings; (2) describe successes, challenges and best practices for each of the three models in Title X and STD clinic settings; and (3) compare the relative strengths and weaknesses of the three models in Title X and STD clinic settings.

Research strategies may employ a mix of quantitative and qualitative methods, as appropriate. Applications may also include additional evaluation elements in the research strategy not listed above that would contribute to the development of best practices for implementing each PrEP service delivery model.

For appropriate indicators, applications should describe how program baseline measures will be established.

For example, historical program data can be used; or, if data is not available, clinics can plan a pre-intervention baseline data collection period prior to implementing models.

Translation Plan The results of this evaluation will be made available to a wide range of potential users and stakeholders. Key findings will be presented at national meetings and published in peer-review journals. Findings related to effective health services models for PrEP provision will also be disseminated to clinicians, the public health workforce, and community-based stakeholders to inform their efforts to implement these models.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $11,000,000 Year 1: $2,000,000

Year 2: $3,000,000

Year 3: $3,000,000

Year 4: $3,000,000

Anticipated Number of Awards:

Award ceiling and floor are for the first 12-month budget period for an individual award.

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

Award Ceiling: $2,000,000 Per Budget Period Award Floor: $1,500,000 Per Budget Period Total Project Period Length:

4 year(s)

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

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education

Additional Eligibility Category:

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

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

Applicant organizations that request funding above the ceiling amount of the award will not be forwarded to peer review or considered for funding.

Applications submitted under this funding opportunity announcement must not include activities that overlap with simultaneously-funded research under other awards.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Applications are expected to describe direct service delivery at Title X and STD clinics, or to demonstrate a formal collaboration with at least 3 clinics of each type which provide these services.

Evidence of collaboration must be provided through letters of support with the collaborating clinics.

The letters of support must be placed in the Letters of Support section of the PHS 398 Research Plan Component of the application.

Applications must provide evidence of collaboration with a healthcare organization, health department, or laboratory, to provide necessary clinical and laboratory data to evaluate the health service models. Evidence of this collaboration must be in the form of letters of support that are placed in the Letters of Support section of the PHS 398 Research Plan Component of the application.

Applications must demonstrate that investigators have experience conducting human subjects research and have access to an institutional review board (IRB) which can approve evaluation protocols;

otherwise, the application must provide evidence of collaboration, via a letter of support, with a partner institution that can provide IRB approval and appropriate research guidance and oversight.

The letter of support must be placed in the Letters of Support section of the PHS 398 Research Plan Component of the application.

Applications must include letter(s) of support from external PrEP provider(s) to whom PrEP-eligible patients at Title X and STD clinics can be referred. The letter(s) of support should include data sharing agreements to ensure that appropriate evaluation data can be collected for referred patients and must be placed in the Letters of Support section of the PHS 398 Research Plan Component of the application.

Applications that do not meet the responsiveness criteria listed above will be considered nonresponsive will not move forward to peer review or be eligible for funding.

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

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

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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

http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf, except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

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

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 12/14/2016 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

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

Name of the Applicant

Descriptive title of proposed research

Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel

Participating institutions

Number and title of this funding opportunity announcement

The letter of intent should be sent to:

Gregory Anderson, MPH, MS http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/forms.htm

Gregory Anderson, MPH, MS

Extramural Research Program Office

Office of the Associate Director of Science

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: 404-718-8833

Fax: 404-718-8822

Email: GAnderson@cdc.gov

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research mailto:GAnderson@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

Please note the new requirement for a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application (see immediately above).

Letters of Support Section:

• Applications are expected to describe direct service delivery at Title X and STD clinics, or to demonstrate a formal collaboration with at least 3 clinics of each type which provide these services. Evidence of collaboration must be provided through letters of support with the collaborating clinics. The letters of support must be placed in the Letters of Support section of the PHS 398 Research Plan Component of the application.

• Applications must provide evidence of collaboration with a healthcare organization, health department, or laboratory, to provide necessary clinical and laboratory data to evaluate the health service models. Evidence of this collaboration must be in the form of letters of support that are placed in the Letters of Support section of the PHS 398 Research Plan Component of the application.

• Applications must demonstrate that investigators have experience conducting human subjects research and have access to an institutional review board (IRB) which can approve evaluation protocols; otherwise, the application must provide evidence of collaboration via a letter of support with a partner institution that can provide IRB approval and appropriate research guidance and oversight. The letter of support must be placed http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php in the Letters of Support section of the PHS 398 Research Plan Component of the application.

• Applications must include letter(s) of support from external PrEP provider(s) to whom PrEP-eligible patients at Title X and STD clinics can be referred. The letter(s) of support should include data sharing agreements to ensure that appropriate evaluation data can be collected for referred patients and must be placed in the Letters of Support section of the PHS 398 Research Plan…