RFA-PS-16-004-AMENDED.pdf

Centers for Disease Control and Prevention

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

Increase Access to Care for Black Men Who Have Sex with Men

RFA-PS-16-004

Application Due Date: 02/12/2016

Increase Access to Care for Black Men Who Have Sex with Men

RFA-PS-16-004

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 and Prevention 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 Increase Access to Care for Black Men Who Have Sex with Men Activity Code U01 Research Project Cooperative Agreements

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-PS-16-004

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

Health FOA Purpose The goals of this FOA are to design and implement an in-person assistance intervention and to evaluate the effects of the intervention on insurance uptake, insurance coverage, and rates of linkage to, and retention in, HIV-related health care and other associated health services among black MSM age 18 or older; intervention cost-benefit will also be assessed.

NOTE: This FOA has been amended in red text to include a Summary of the Conference Call with Potential Applicants held on January 5, 2016 (Section VIII., pages 39-41) and to include a missing bullet in the Process Evaluation Data section of the FOA (Section I.2, page 10).

Key Dates Publication Date: To receive notification of any changes to RFA-PS-16-004, 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: 01/07/2016

Application Due Date: 02/12/2016

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

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

http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U01&Search_Type=Activity&Search.x=16&Search.y=3 http://www.grants.gov

Scientific Merit Review: 04/26/2016

Secondary Review: 05/25/2016

Estimated Start Date: 08/31/2016

Expiration Date: 02/13/2016 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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

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

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose. The goals of this FOA are to design and implement an in-person assistance intervention and to evaluate the effects of the intervention on insurance uptake, insurance coverage, and rates of linkage to, and retention in, HIV-related health care and other associated health services among black MSM age 18 or older; intervention cost-benefit will also be assessed.

Mechanism of Support. Cooperative agreement.

Funds Available and Anticipated Number of Awards. The estimated total funding available is up to $400,000 for the first 12-month budget period and up to $1,500,000 for the entire project period of three (3) years. The anticipated number of awards is one. 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 $400,000. Estimated funding for the second and third years is $600,000 and $500,000, respectively. The estimated total funding (direct and indirect) for the entire project period is $1,500,000. The project period will run from 08/31/2016 to 8/30/2019.

Application Research Strategy Length. Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement. For this FOA, the page limit for the Research Strategy section of the Research Plan is 25 pages.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1 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 per application. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and this must be indicated in the application.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf be indicated in the application.

Number of Applications. Eligible applicant institutions may submit only one application.

Application Type. New.

Special Date(s). A conference call with all potential applicants will be held on Tuesday, January 5, 2016 at 12:00 noon Eastern Time. Phone Number: 1-866-662-8986; Passcode: 8378091.

Application Materials. See Section IV.1 for application materials. Please note that Form C is to be used when downloading the application package. http://grants.nih.gov/grants/funding/424/SF424 _RR_Guide_General_VerC.pdf Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

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 247c), as amended.

1. Background and Purpose In 2010, men who have sex with men (MSM) accounted for 78% of new HIV infections among males and 63% of all new infections. Even though African Americans comprise only 12% of the US population, black MSM almost matched white MSM in numbers of new HIV infections (10,600 and 11,200, respectively)(1).

Black MSM face obstacles to seeking preventive or medical care and following through with referrals or appointments, such as costs and lack of health insurance due to unemployment, under-employment, or low literacy skills that impede use of insurance websites (2,3). Recent studies found that approximately 40% of black MSM are uninsured or had a lapse in health insurance coverage in the previous 12 months (3,4). The fact that HIV-infected black MSM have positive health outcomes once they become engaged in care argues for the cost-effectiveness of removing obstacles to access (5,6). An intervention to help black MSM, especially young black MSM, overcome socioeconomic obstacles to health care can improve the health and health care seeking of all black MSM, regardless of their HIV status, and can prevent transmission and acquisition of HIV among at-risk black MSM. Although the focus of this FOA is on black MSM, especially young black MSM, other racial and ethnic groups will not be denied access to services.

Under this FOA, applicant organizations will implement a structural intervention to remove an obstacle to health care access: lack of health insurance. Applicant organizations will implement and evaluate provision of an in-person assistance intervention to help black MSM clients, age 18 and older, regardless of their HIV status, to enroll as policy holders in health insurance or Medicaid according to the Patient Protection and Affordable Care Act (ACA) at the end of their HIV testing session (7). The intervention aligns with the Office of Management and Budget’s (OMB’s) emphasis on application of behavioral insights (8,9).

Behavioral insights are used to restructure the context in which health-related decision-making occurs in order to promote the selection of beneficial options. Enrollment assistance changes choice context by improving the convenience of the enrollment process, reducing anxiety about making mistakes, providing guidance on choice of insurance plans, and reducing clients’ time costs, because health insurance enrollment is combined with another activity (HIV testing).

The goals of this FOA are to design and implement an in-person assistance intervention and to evaluate the effects of the intervention on insurance uptake, insurance coverage, and rates of linkage to, and retention in, HIV-related health care (i.e., HIV treatment, Pre-exposure Prophylaxis [PrEP]) and other associated health services (e.g., mental health counseling, substance use treatment) among black MSM age 18 or older. Intervention cost-benefit will also be assessed.

Specifically, the project will explore whether providing in-person assistance to enroll in health insurance or Medicaid following HIV testing will: 1) increase the proportion of black MSM who obtain health insurance;

Medicaid following HIV testing will: 1) increase the proportion of black MSM who obtain health insurance;

2) result in better health outcomes among clients; 3) improve the linkage and retention rates of black MSM, especially those diagnosed with HIV; and 4) increase linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis). Analyses will be used to assess the efficacy of the intervention as an emerging practice. During an HIV testing event, all black MSM clients will receive services that include, but are not limited to, an HIV test and test results, referral to needed psychosocial services, and enrollment in health insurance or Medicaid, if needed. Black MSM clients who test positive for HIV will also receive linkage to HIV care services, patient navigation, and partner services according to local protocols. The certified Centers for Medicare and Medicaid Services (CMS) navigator or certified application counselor (CAC) who provides the enrollment assistance, or a colleague accompanying that person, will be the person administering the HIV test.

References:

1. HIV in the United States: At A Glance. Accessed November 25, 2014 from http://wwwdev.cdc.gov/hiv /statistics/basics/ataglance.html

2. Millett GA, et al. Comparisons of disparities and risks of HIV infection in black and other men who have sex with men in Canada, UK, and USA: a meta-analysis. Lancet 2012; 380(9839):341-348.

3. Sullivan PS, et al. Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: a prospective observational cohort study. Annals of Epidemiology 2015;

25(6):445-454.

4. Hall G, et al. A Comparison of referred sexual partners to their community recruited counterparts in The BROTHERS Project (HPTN 061). AIDS Behav. 2015 Feb 11.

5. Moving Black MSM Along the HIV Care Continuum webinar. Accessed August 16, 2014 from http ://www.aids.gov/pdf/bmsm-webinar-06252014.pdf.

6. Turning the Tide on HIV, Division of HIV/AIDS Prevention Annual Report 2013. Accessed August 16, 2014 from http://www.cdc.gov/hiv/pdf/policies_dhap_annualreport_2013.pdf.

7. In-Person Assistance in the Health Insurance Marketplaces, Centers for Medicare and Medicaid Services, Center for Consumer Information and Insurance Oversight. Accessed November 24, 2014 from http://www .cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html.

8. OMB Memorandum M-13-17: Next Steps in the Evidence and Innovation Agenda. July 2013 from http ://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf . Accessed November 25, 2014.

9. Bettinger EP, et al. The role of application assistance and information in college decisions: results from the H&R Block FAFSA experiment. The Quarterly Journal of Economics 2012; 127(3):1205-1242.

10. Recommendations for HIV prevention with adults and adolescents with HIV in the United States, 2014.

Accessed May 4, 2015 from http://stacks.cdc.gov/view/cdc/26062 .

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 http://wwwdev.cdc.gov/hiv/statistics/basics/ataglance.html http://wwwdev.cdc.gov/hiv/statistics/basics/ataglance.html http://www.aids.gov/pdf/bmsm-webinar-06252014.pdf http://www.aids.gov/pdf/bmsm-webinar-06252014.pdf http://www.cdc.gov/hiv/pdf/policies_dhap_annualreport_2013.pdf http://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html http://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html http://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf http://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf http://stacks.cdc.gov/view/cdc/26062 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

/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 This FOA aligns with the National HIV/AIDS Strategy goals (http://www.whitehouse.gov/sites/default/files /uploads/NHAS.pdf):

Reducing new HIV infections Increasing access to care and improve health outcomes for people living with HIV Reducing HIV-related health disparities

This announcement also supports several Healthy People 2020 (HP2020) objectives. The HP2020 objectives supported by this announcement include:

HIV-6: Reduce new AIDS cases among adolescent and adult men who have sex with men HIV-13: Increase the proportion of persons living with HIV who know their serostatus HIV-19: Increase the proportion of persons who are linked to HIV medical care within 3 months of HIV diagnosis HIV-20: Increase the proportion of persons with an HIV diagnosis who had at least one HIV medical care visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between medical visits HIV-21: Increase the proportion of persons with an HIV diagnosis in medical care who were prescribed antiretroviral therapy for the treatment of HIV infection at any time in the 12-month measurement period HIV-22: Increase the proportion of persons with an HIV diagnosis in medical care with a viral load <200 copies/mL at the last test during the 12-month measurement period

This FOA aligns with OMB’s emphasis on the application of behavioral insights (https://www.whitehouse .gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf ) and has the potential to identify a scalable, structural-level intervention for black MSM and contribute to reducing HIV infection among this population.

Finally, CDC has identified HIV prevention as a winnable battle. This FOA aligns very closely with the 3 key strategies of CDC’s HIV winnable battle effort (http://www.cdc.gov/winnablebattles/hiv/index.html ):

Intensify HIV prevention efforts in communities where HIV is most heavily concentrated Expand targeted efforts to prevent HIV infection using a combination of effective, evidence-based http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf http://www.cdc.gov/winnablebattles/hiv/index.html approaches for persons living with HIV and those at high risk of infection Maximize the proportion of people with HIV who have suppressed viral load by improving diagnosis, linkage and retention in care, and antiretroviral provision and adherence

Additional strategic priorities:

CDC Division of HIV/AIDS Prevention (DHAP) Strategic Plan: http://www.cdc.gov/hiv/pdf/polic ies_DHAP-strategic-plan.pdf

1.

Executive Order (July 15, 2013): www.whitehouse.gov/the-press-office/2013/07/15/executive-order -hiv-care-continuum-initiative

2.

Minority AIDS Initiative (MAI): http://www.hhs.gov/ash/ohaidp/initiatives/3.

Affordable Care Act: http://aids.gov/federal-resources/policies/health-care-reform4.

Standards for Privacy of Individually Identifiable Health Information: http://privacyruleandresearch .nih.gov/

5.

Public Health Impact In 2010, men who have sex with men (MSM) accounted for 78% of new HIV infections among males and 63% of all new infections. Even though blacks comprise only 12% of the US population, black MSM nearly equal white MSM in numbers of new HIV infections (10,600 and 11,200, respectively). HIV-infected black MSM have positive health outcomes once they become engaged in care; however, black MSM face obstacles to accessing preventive or medical care or following through with referrals or appointments, such as costs and lack of health insurance due to unemployment, under-employment, or low literacy skills that impede use of insurance websites.

This FOA will evaluate an intervention to help black MSM, especially young black MSM, overcome socioeconomic obstacles to accessing health care which can improve the health and health care-seeking of black MSM, regardless of their HIV status, and can prevent transmission and acquisition of HIV among at-risk black MSM. The intervention will be an in-person enrollment assistance, following HIV testing, to help black MSM obtain health insurance or Medicaid. Intervention effects on insurance uptake, insurance coverage, and rates of linkage to, and retention in, HIV-related health care (i.e., HIV treatment, PrEP) and other associated health services (e.g., mental health counseling, substance use treatment) will be assessed. If demonstrated to be efficacious, the intervention can be quickly adopted by organizations that provide HIV testing targeted to black MSM.

Relevant Work

1. Bettinger EP, et al. The role of application assistance and information in college decisions: results from the H&R Block FAFSA experiment. The Quarterly Journal of Economics. 2012;127(3): 1205-1242.

2. Blankenship KM, Bray SJ, Merson MH. Structural interventions in public health. AIDS. 2000; 14 (Suppl.

1):11-21.

3. Centers for Disease Control and Prevention. (2011). High-Impact HIV Prevention: CDC’s Approach to Reducing HIV Infections in the United States. Accessed May 1, 2015 from http://www.cdc.gov/hiv/strategy /dhap/pdf/nhas_booklet.pdf

4. Freeman JD, Kadiyala S, Bell JF, Martin DP. The causal effect of health insurance on utilization and outcomes in adults: a systematic review of US studies. Medical Care 2008; 46(10):1023-32.

5. Frieden TR. A framework for public health action: The health impact pyramid. Am J Public Health.

2010; 100(4):590-595.

6. In-Person Assistance in the Health Insurance Marketplaces, Centers for Medicare and Medicaid Services, Center for Consumer Information and Insurance Oversight. Accessed November 24, 2014 from http://www .cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html.

http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.pdf http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.pdf http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order-hiv-care-continuum-initiative http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order-hiv-care-continuum-initiative http://www.hhs.gov/ash/ohaidp/initiatives/ http://aids.gov/federal-resources/policies/health-care-reform http://privacyruleandresearch.nih.gov/ http://privacyruleandresearch.nih.gov/ http://www.cdc.gov/hiv/strategy/dhap/pdf/nhas_booklet.pdf http://www.cdc.gov/hiv/strategy/dhap/pdf/nhas_booklet.pdf http://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html http://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html

7. Millett GA, et al. Comparisons of disparities and risks of HIV infection in black and other men who have sex with men in Canada, UK, and USA: a meta-analysis. Lancet 2012; 380(9839):341-348.

8. Moving Black MSM Along the HIV Care Continuum webinar. Accessed August 16, 2014 from http ://www.aids.gov/pdf/bmsm-webinar-06252014.pdf.

9. Office of National AIDS Policy. National HIV/AIDS Strategy for the United States [Report] July 2010.

Accessed April 20, 2015 from https://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf .

10. OMB Memorandum M-13-17: Next Steps in the Evidence and Innovation Agenda. July 2013. Accessed November 25, 2014 from http://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf .

11. Thornton JA, Rice JL. Does extending health insurance coverage to the uninsured improve population health outcomes? Appl Health Econ and Health Policy 2008; 6(4):217-30.

12. Turning the Tide on HIV, Division of HIV/AIDS Prevention Annual Report 2013. Accessed August 16, 2014 from http://www.cdc.gov/hiv/pdf/policies_dhap_annualreport_2013.pdf.

13. Wejnert, Cyprian, et al. HIV infection and awareness among men who have sex with men–20 cities, United States, 2008 and 2011.PloS One 8.10 (2013): e76878.

2. Approach Applications submitted in response to this FOA should:

Propose partnering with more than one type of community-based organization (CBO) to demonstrate the ability to evaluate different ways to implement the intervention.

Include a detailed description of the applicant’s and partner organizations’ access to, or plan for gaining access to, black MSM at high risk for acquiring or transmitting HIV for purposes of the research project.

Include a detailed description of the applicant’s and partner organizations’ ability to recruit sufficient numbers of the target population for proposed research activities.

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

Investigators will design, implement and evaluate provision of an in-person assistance intervention to help black MSM clients enroll as policy holders in health insurance or Medicaid, according to the Patient Protection and Affordable Care Act (ACA), at the end of their HIV testing session, regardless of their HIV status. The goals of the FOA are to evaluate the effects of the intervention on insurance uptake, insurance coverage, and rates of linkage to and retention in HIV-related health care (i.e., HIV treatment, PrEP) and other associated health services (e.g., mental health counseling, substance use treatment). Intervention cost-benefit will also be assessed. CDC will coordinate with the Centers for Medicare and Medicaid Services (CMS) and Health Resources and Services Administration (HRSA) to assist awardees in planning, developing, implementing, and evaluating the intervention.

Analyses will be used to assess the efficacy of the intervention as an emerging practice.

During an HIV test event, all black MSM clients will receive services that include, but are not limited to, an HIV test and test results, referral to needed psychosocial services, and enrollment in health insurance or Medicaid, if needed. Black MSM clients who test positive for HIV infection will also receive linkage to care services, patient navigation, and partner services according to local protocols. The certified CMS navigator or certified application counselor (CAC) who provides the enrollment assistance or a colleague accompanying that person will be the person administering the HIV test.

During the course of this study, investigators will be expected to:

http://www.aids.gov/pdf/bmsm-webinar-06252014.pdf http://www.aids.gov/pdf/bmsm-webinar-06252014.pdf https://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf http://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf http://www.cdc.gov/hiv/pdf/policies_dhap_annualreport_2013.pdf

Obtain Institutional Review Board (IRB) and Office of Management and Budget (OMB) approvals for the data collection and analyses.

Perform HIV testing targeting black MSM according to local protocols, including providing referral to psychosocial services, linkage to health care services, patient navigation, and partner services.

Integrate the intervention into targeted HIV testing programs during marketplace insurance open enrollment months (November 1-January 31).

Employ or acquire lap-top computers to enroll clients during fixed location and mobile outreach HIV testing.

Partner with Community-Based Organizations (CBOs) to implement the in-person enrollment assistance intervention using either certified CMS navigators or CACs. Navigators and CACs can be in-house staff, obtained from a CMS Navigator grantee, or who are (CBO) staff trained with project funds. The number of these staff members should be appropriate for the workload of the proposed intervention activity.

Have a procedure in place to refer all study ineligible persons, regardless of race or ethnicity, to services consistent with local standards of care, e.g., existing healthcare services and insurance enrollment assistance.

Offer the in-person health insurance enrollment assistance intervention to all black MSM during marketplace open enrollment months, unless they are covered by their parents’ health insurance.

Collect data on black MSM clients receiving an HIV test when marketplace insurance enrollment is open (intervention condition). These data will include health insurance status, insurance enrollment decision (and why), source of insurance (Medicaid or Marketplace) acquired through the intervention, choice of change of insurance plan (and why), and housing status. Additional health outcomes may be proposed, especially outcomes whose measures are in existing administrative datasets. For black MSM clients who are referred to HIV-related health care or HIV-associated health services, also collect data on linkage to and retention or reengagement in that care or service.

Integrate provision of publically available information on health insurance enrollment into targeted HIV testing programs during months when marketplace insurance enrollment is closed (February 1-October 31). Information should not mention the grantee’s provision of the intervention.

Collect data on black MSM clients receiving an HIV test when marketplace insurance enrollment is closed (comparison condition). These data will include health insurance status and housing status.

Additional health outcomes may be proposed, especially outcomes whose measures are in existing administrative datasets. For black MSM clients who are referred to HIV-related health care or HIV-associated health services, data should also be collected on linkage to, and retention or reengagement in, that care or service.

Not provide in-person assistance with Medicaid enrollment during months when marketplace insurance enrollment is closed.

Collect data on each CBO’s integration of the intervention and protocols, number of staff receiving navigator or application counselor certification, and costs associated with implementing the in-person enrollment assistance intervention.

Conduct quality assurance activities and process evaluation studies with partner sites and CBOs.

During the course of the FOA project period, it is expected that investigators will align research activities to the following schedule and timeline:

Year 1: Establish a Memorandum of Understanding (MOU) with partnering organizations; develop and submit a comprehensive protocol for local and CDC IRBs, and other reviews and approvals as needed (such as OMB); acquire lap-top computers; pilot assessment instruments to be used for the research project; get CBO staff trained as CACs, as needed;

Year 2: Implement the intervention during open enrollment months; conduct evaluation of participants in treatment and comparison conditions, conduct follow-up assessments;

Year 3: Implement the intervention during open enrollment months; conduct evaluation of participants in treatment and comparison conditions; complete remaining follow-up assessments; conduct data cleaning and data analyses; disseminate the findings.

A sample project timeline is described in Figure 1 below.

FIGURE 1: SAMPLE PROJECT TIMELINE USING AN INSTITUTIONAL CYCLE DESIGN

B = baseline observation months

O = follow-up observation months

= cyclic intervention event (in-person health insurance enrollment assistance) months

Sample follow-up observation points: For participants referred to HIV-related health care (i.e., HIV treatment, PrEP) in each sample:

Linkage to HIV-related health care within 3 months1.

Completion of at least one HIV-related health care visit within 6 months2.

Completion of at least two HIV-related health care visits within 12 months3.

Note: Each row (N=4) represents a separate cohort. The two cohorts from marketplace open enrollment months (s2, s4) can be combined for analysis. The two cohorts from months during which marketplace insurance enrollment is closed (s1, s3) can be combined for analysis.

In order to accomplish the objectives and meet the goals of the FOA, investigators should include detailed procedures for the research design, implementation of the intervention for black MSM, the collection of quality assurance, process, and outcome data, and analysis of outcomes, including criteria for assessing strength of the evidence of intervention effect, in their research plan proposal.

To meet published design criteria for evidence-based interventions for improving participation in HIV care as described by the CDC (http://www.cdc.gov/hiv/prevention/research/compendium/lrc/bestpractices.html), the proposed research plan should include the following study elements:

Criteria for Study Design:

Prospective or quasi-prospective study design.

Appropriate and concurrent comparison arm, or appropriate non-concurrent comparison arm that was implemented in a different clinic or agency within 12 months of the start of the intervention and was similar with respect to population and setting.

YEAR 1 YEAR 2 YEAR 3

S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A

Obtain OMB and IRB approvals s1 B B O O O s2 B B B O O O s3 B B B O O O s4 B B B O O http://www.cdc.gov/hiv/prevention/research/compendium/lrc/bestpractices.html

Random allocation of participants to study arms or if non-randomization, potential bias in allocation to intervention is minimized.

The study is amenable to evaluation using an Institutional Cycle design as described in Figure 2, below.

FIGURE 2: BASIC INSTITUTIONAL CYCLE DESIGN

Os1 Os1

X Os2 Os2

Os3 Os3

X Os4 Os4 ------------------------------------------------------TIME------------------------------------------------->

O = observation events of the same groups sX = number of the different samples that are used

X = cyclic intervention events

Intervention Implementation Benchmarks:

For linkage to care interventions, linkage to care occurs within or less than 6 months after the initiation of the intervention.

For retention in care interventions, retention in care occurs at least 6 months after the initial care visit.

Quality Assurance Plan:

The application’s research plan should describe procedures for collection and analysis of quality assurance measures and application of findings to ensure that the insurance enrollment intervention is delivered with fidelity by well-trained and qualified staff, including, but not limited to:

Guidance for the implementation of the intervention for black MSM during the study period, including recruitment and retention of new participants.

Procedures to prevent confounding between study conditions.

A logic model that specifies intervention components or activities and the outcomes expected for each component.

Process Evaluation Data:

The application’s research plan should describe procedures for collection and analysis of process evaluation data to understand the implementation of in-person health insurance enrollment assistance following HIV testing. Process evaluation data will include, but may not be limited to:

Types and characteristics of partner CBOs implementing the intervention Source(s) of the CMS navigators or CACs who enroll the clients Characteristics of the CMS navigators or CACs Characteristics of study period HIV testing events Number of black MSM participating at each HIV testing event during the project period Number of black MSM who are offered HIV tests and the number who accept testing Number of black MSM participating at each HIV testing event who have no health insurance

Number of black MSM who accept testing who are offered insurance enrollment assistance and the number who accept assistance Characteristics of black MSM who are offered in-person health insurance enrollment assistance Insurance enrollment decision and reason(s) for the decision Change of insurance plan decision and reason(s) for the decision Numbers and types of referrals given Participants’ perceptions of and reactions to the intervention activities and services provided Resources used to deliver the intervention (including basic costs associated with delivering the intervention) Modifications made to the intervention implementation procedures

Outcome Evaluation Data:

Collection and analysis of the following outcome evaluation data from at least 400 black MSM during treatment months and at least 400 black MSM during comparison months:

Number of black MSM who are successfully enrolled for the first time Number of black MSM who change their insurance plan Number of newly-enrolled black MSM who enroll in Medicaid and number who enroll in private insurance through the Marketplace Number of black MSM who enroll or change plans through the Marketplace who enroll in bronze level of coverage, number who enroll in silver, and number who enroll in gold or platinum For participants referred to HIV-related care (i.e., HIV medical care, PrEP)

Length of time between when the first completed HIV-related care visit (linkage) occurred and when the study period HIV test was performed Length of time between when subsequent HIV-related care visits (retention) occurred and when the study period HIV test was performed Percent who completed at least one HIV-related medical visit after their study period HIV test was performed Percent who completed at least 2 HIV-related medical visits within 12 months after their study period HIV test was performed

For participants referred to HIV-associated health services (e.g., mental health counseling, substance use treatment)

Length of time between when the first completed HIV-associated health service visit (e.g., initial assessment) occurred and when the study period HIV test was performed Length of time between when subsequent HIV-associated health service visits (e.g., entry into withdrawal or recovery program) occurred and when the study period HIV test was performed Additional HIV-associated health outcomes, with appropriate measures may be proposed

For participants with previously-diagnosed HIV infection and who were never in HIV care Length of time between when first positive test for HIV infection occurred and when the study period HIV test was performed Length of time between when the first completed HIV medical visit (linkage to care) occurred and when the study period HIV test was performed

For participants with previously-diagnosed HIV infection and who had left HIV care Length of time between their most recent HIV medical visit and when the study period HIV test was performed Length of time between when the next completed HIV medical visit (reengagement in care) occurred and when the study period HIV test was performed

Criteria for Analysis of Outcomes:

Analysis of participants in study arms as originally allocated, or contaminated participants may be excluded if numbers are small, but participants may not be re-assigned for analytic purposes Analysis of participants may be based on intervention exposure, where participants exposed to < 50% of the entire intended intervention may be excluded Analysis must be based on between-group comparisons on post-intervention levels or on pre-post changes in measures

For pre-post changes used in analysis, measures must be identical, including identical recall period

Analysis based on a 2-sided test with a p value ≤ 0.05 With non-randomized assignment, either no statistical differences exist in baseline levels of the outcome measure, or baseline differences must be controlled for in the analysis. If moderately biased assignment or historical comparison was used, differences in baseline demographics also must be controlled for in the analysis Baseline sample of ≥ 40 participants (or charts) per study arm

Criteria for Assessing Strength of Evidence of Intervention Effect:

Statistically significant (p ≤ 0.05) positive intervention effect for ≥ 1 relevant outcome measure A positive intervention effect is defined as an improvement in linking to, retention in, or re-engagement in HIV medical care in the intervention arm relative to the comparison arm A relevant outcome is defined as an actual/completed outpatient primary HIV medical care visit or HIV viral load and/ or CD4 count when used as proxies for a HIV medical care visit

Completed HIV medical visits must be documented in medical records, administrative or agency records, or surveillance reports Self-reports of completed medical visits validated by medical records, administrative or agency records are also acceptable

- For linkage to HIV medical care, a relevant outcome is the actual/completed first HIV medical visit for newly diagnosed HIV-positive persons

- For retention in HIV medical care, a relevant outcome is having actual/completed multiple HIV medical visits over a period of time

- For re-engagement in HIV medical care, a relevant outcome is the actual/completed initial HIV medical visit for HIV-positive persons who have fallen out of, but have returned to, HIV care

Effect at a required follow-up assessment time point and based on the analyses that meets all study implementation and analysis criteria No statistically significant (p ≤ 0.05) negative intervention effect for any relevant outcome

A negative intervention effect is defined as a worsening in linkage to, retention in, or re-engagement in HIV medical care in the intervention arm relative to the comparison arm

No other statistically significant harmful intervention effect that causes substantial concern For an intervention with a replication evaluation, no significant negative intervention effects in the replication study if the intervention was implemented in the exact same way as the original study and with the same or similar cohort/population

Target Population Black MSM, age 18 and older, at high risk for HIV infection or who are HIV-infected and in need of HIV care and treatment services.

Collaboration/Partnerships Expected partnerships include: 1) CBOs that are already CMS navigator grantees (NGs) or State Exchange designated organizations (SEDOs) that will add the intervention to their HIV testing and linkage services targeted to black MSM; 2) CBOs that are non-NG/SEDO and that will partner with existing NG/SEDOs to acquire navigators or CACs on an as-needed-basis; and 3) CBOs that are non-NG/SEDO and that will have individual staff members become CACs directly certified by their State Exchange. Key stakeholders include the Centers for Medicare and Medicaid Services (CMS) regional office and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau state program in the applicant’s jurisdiction.

Evaluation/Performance Measurement As part of the application, investigators should include measurable goals and aims based on a three-year research project period. The grantee will collaborate with CDC to: 1) establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the applicant’s project plan, and 2) develop and implement project performance measures that are based on specific programmatic objectives.

Examples of goals and aims for this research study will include but not be limited to:

Developing and implementing research study protocols and consent forms necessary to support the proposed research design for the in-person assistance intervention to help black MSM clients enroll in health insurance or Medicaid.

Identifying CBO partners and stakeholders, to provide access to medical care, including HIV testing and treatment, substance abuse treatment and prevention services.

Obtaining appropriate local Institutional Review Board(s) approvals for all participating study sites, as required.

Obtaining appropriate OMB-PRA approval for data collection instruments and analyses, as required.

Identifying and enrolling the targeted population of black MSM at high risk for HIV infection or who are HIV-infected and in need of HIV care and treatment services for the intervention and comparison study arms.

Conducting follow-up assessment and testing for HIV infection or reinfection.

Developing a guidance document for the implementation of the intervention for black MSM, including recruitment and follow-up of new participants.

Also, funded PIs must submit an annual progress report showing their activities and outcomes based on their overall research goals and timeline. For more information on required Reporting, please see Section VI of this FOA.

Translation Plan The application should describe how the findings from this study could be used to inform public health policy or practice. During the study period the grantee will develop a guidance document for the implementation of the intervention for black MSM, age 18 and older, including recruitment and follow-up of new participants. This guidance document will be one mechanism for disseminating the project’s research findings. Other mechanisms may include conference presentations and publications in peer-reviewed journals.

This section of the application should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The application should identify the research findings that can be used to inform public health policy or practice and how the findings may be adopted in public health settings. The application should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, the application should describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:

- How will the scientific findings inform public health policy or practice?

- How will the project improve or effect the translation of research findings into policy or practice?

- How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?

- How will the findings advance or guide future research efforts or related activities?

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: $1,500,000 Year 1: $400,000

Year 2: $600,000

Year 3: $500,000

Estimated funding available, including direct and indirect costs, for the first 12-month budget period:

$400,000.

Estimated funding available, including direct and indirect costs, for the entire three-year project period:

$1,500,000.

Anticipated Number of Awards: 1 The ceiling for an individual award, including direct and indirect costs, for the first 12-month budget period:

$400,000.

The floor for an individual award, including direct and indirect costs, for the first 12-month budget period:

$0.

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

Award Ceiling: $400,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 3 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/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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 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 Others (see text field entitled "Additional Information on Eligibility" for clarification)

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…