cdc-rfa-ps-15-1509.pdf

Centers for Disease Control and Prevention

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

Health Department Demonstration Projects for Comprehensive Prevention, Care, Behavioral Health, and Social Services for Men Who Have Sex with Men of Color at Risk for and Living with HIV Infection

CDC-RFA-PS15-1509

Application Due Date: 06/01/2015

Health Department Demonstration Projects for Comprehensive Prevention, Care, Behavioral Health, and Social Services for Men Who Have Sex with Men of Color at Risk for and Living with HIV Infection

CDC-RFA-PS15-1509

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS15-1509. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Funding Opportunity Title:

Health Department Demonstration Projects for Comprehensive Prevention, Care, Behavioral Health, and Social Services for Men Who Have Sex with Men of Color at Risk for and Living with HIV Infection C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc.gov/od/science /integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-PS15-1509

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.940 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 06/01/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A http://www.cdc.gov/hiv/policies/funding/announcements/ps15-1509/index.html

G. Executive Summary:

1. Summary Paragraph:

Gay, bisexual, and other men who have sex with men (MSM) remain the population most affected by HIV infection in the United States (US). Among MSM, those who are black and Hispanic comprise 58% of all new infections. The purpose of this FOA is to support state and localhealth departments and their community partners to provide comprehensive models of HIV prevention and care services for MSM of color.

Antiretroviral (ARV) medications can be used for HIV prevention by MSM at substantial risk for HIV acquisition (pre-exposure prophylaxis (PrEP)) or for those with a risk event that occurred in the past 72 hours (post-exposure prophylaxis (nPEP)). ARV treatment for persons living with HIV (PLWH) is also a potent prevention tool that suppresses HIV viral load, improving health outcomes and reducing the risk of transmission. The effectiveness of HIV treatment to prevent transmission has led to increased focus on interventions and strategies to link, retain, and re-engage PLWH in healthcare, and to support medication adherence. Given the high incidence of HIV among MSM of color, those who are sexually active are considered at risk for HIV acquisition and could benefit from screening with 4 th generation HIV tests and should be assessed for PrEP or nPEP indications. MSM of color at risk for HIV acquisition and living with HIV would benefit from screening for sexually transmitted diseases (STDs), partner services, and behavioral risk reduction interventions. These high impact HIV prevention services will be implemented by state, local, and territorial health departments to reduce HIV infections and improve HIV outcomes for MSM of color. In addition, the health benefits of HIV prevention and care services will be enhanced by addressing social, economic, and structural factors influencing HIV health outcomes, through linkage to mental health, http://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov http://www.cdc.gov/hiv/policies/funding/announcements/ps15-1509/index.html economic, and structural factors influencing HIV health outcomes, through linkage to mental health, substance abuse, housing, and employment services.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 6 Up to 8 awards

d. Total Project Period Funding: $60,500,000

e. Average One Year Award Amount: $0 1st year: $ $1,750,000; 2nd year: $1,812,500; 3rd year: $1,937,500; 4th year: $; $2,062,500

f. Number of Years of Award: 4

g. Estimated Award Date: 09/30/2015

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

Approximately 50,000 people in the United States (US) are newly infected with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) remain the US population most heavily affected by HIV infection. Among MSM, those who are black and Hispanic comprise 58% of all new infections. To address the burden of HIV in this population, high impact HIV prevention approaches should be implemented by state, local, and territorial health departments to reduce new HIV infections among MSM of color, and to improve outcomes along the HIV continuum of care for MSM of color living with HIV.

Antiretroviral (ARV) medications can be used for HIV prevention by MSM at substantial risk for HIV acquisition (pre-exposure prophylaxis (PrEP)) or by those with a possible HIV exposure in the past 72 hours (post-exposure prophylaxis (nPEP)). The daily use of co-formulated tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada) for PrEP has been proven to significantly reduce the risk of HIV acquisition among sexually active MSM. In July 2012, the US Food and Drug Administration approved an HIV prevention indication for Truvada, and in May 2014 CDC published clinical practice guidelines for provision of PrEP. Given the high incidence of HIV among MSM of color, those who are sexually active are considered at risk for HIV acquisition and thus could benefit from prevention services such as routine and frequent HIV screening with lab-based 4th generation HIV tests, rountine screening for STDs, assessment of PrEP eligibility, provision of PrEP (if at substantial risk for HIV acquisition), provision of nPEP (if a possible HIV exposure occurred in the past 72 hours), and/or other risk reduction interventions.

Among PLWH, ARV treatment is a potent prevention tool than can suppress HIV viral load, which both improves health outcomes of individuals and reduces the risk of HIV transmission. A study that demonstrated the effectiveness of ARV treatment in preventing HIV transmission has led to increased public health focus on interventions and strategies designed to link, retain, and re-engage PLWH in HIVcare, and to provide support for adherence to ARV medications.

The purpose of this FOA is to support state and local health departments to develop and implement demonstration projects for provision of comprehensive HIV prevention and care services for MSM of color by creating a collaborative with CBOs, clinics and other health care providers, and behavioral health and social services providers in their jurisdiction (Figure 1). Behavioral health services include mental health and substance abuse treatment to enable MSM of color to utilize HIV prevention and care services; social services include services that promote access to housing, job counseling, and employment services to enable MSM of color to utilize HIV prevention and care services. The models should, ultimately, be sustainable beyond the duration of the project period, with resources provided for ongoing HIV prevention and care in the jurisdiction.

Health departments will develop the capacity to train members of the collaboratives to provide culturally competent and linguistically appropriate prevention, care, and behavioral health and social services for MSM of color using a curriculum that will be developed in a companion FOA (CDC-RFA-15-1510) that will support the efforts described in this FOA. The health benefits of HIV prevention and care services can be enhanced by addressing the social, economic, and structural factors influencing prevention of HIV acquisition among MSM of color and HIV-related health outcomes among those living with HIV. This FOA requires that collaboratives assess the needs of MSM of color for mental health, substance abuse, housing, and employment services, and provide linkages to these services in the community.

b. Statutory Authorities

This program is authorized under Section 301(a) (42 U.S.C Section 241(a)

c. Healthy People 2020

This FOA addresses the following “Healthy People 2020” objectives:

https://www.healthypeople.gov/2020/topics-objectives/topic/hiv

HIV-2 Reduce the number of new HIV infections among adolescents and adults

HIV-3 Reduce the rate of HIV transmission among adolescents and adults https://www.healthypeople.gov/2020/topics-objectives/topic/hiv

HIV-13 Increase the proportion of persons living with HIV who know their serostatus

HIV-14 Increase the proportion of adolescents and adults who have been tested for HIV in the past 12 months

HIV-19 (Developmental) Increase the proportion of persons who are linked to HIV medical care (had a routine HIV medical visit) within 3 months of HIV diagnosis

HIV-20 (Developmental) 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 (Developmental) 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

d. Other National Public Health Priorities and Strategies

1. The National HIV/AIDS Strategy: http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf

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

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

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

5. CDC Winnable Battles: http://www.cdc.gov/winnablebattles/hiv/index.html

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

7. The Rehabilitation Act and the Americans with Disabilities Act (ADA): http://www.ada.gov/cguide.htm

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

9. This FOA supports a holistic framework that enables NCHHSTP to address the broader, cross-cutting issues of health and wellness by addressing Health Equity, Program Collaboration and Service Integration (PCSI), and Advancing Public Health Approaches to Improve Sexual Health. Additional information about these imperatives is available: http://www.cdc.gov/nchhstp

e. Relevant Work

This FOA builds upon current HIV prevention programs, projects, and technical assistance efforts including:

• CDC-RFA-PS-12-1201, “Comprehensive HIV Prevention Programs for Health Departments” http://www .cdc.gov/hiv/policies/funding/announcements/ps12-1201/index.html

• CDC-RFA-PS-12-1210, “Secretary’s Minority AIDS Initiative Funding for Care and Prevention in the United States (CAPUS) Demonstration Project http://www.cdc.gov/hiv/policies/funding/announcements/ps12 -1210/index.html

• CDC-RFA-PS13-1302, “ National HIV Surveillance System (NHSS)” http://www.cdc.gov/hiv/policies/fundi ng/announcements/ps13-1302/index.html

• CDC-RFA-PS14-1403, “Capacity Building Assistance (CBA) to Improve the Delivery and Effectiveness of Human Immunodeficiency Virus (HIV) Prevention Services for High-risk and/or Racial/Ethnic Minority Populations, Category C: CBA for Health Departments” http://www.cdc.gov/hiv/topics/funding/PS14-1403 http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf 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://www.cdc.gov/winnablebattles/hiv/index.html http://aids.gov/federal-resources/policies/health-care-reform http://www.ada.gov/cguide.htm http://privacyruleandresearch.nih.gov/ http://privacyruleandresearch.nih.gov/ http://www.cdc.gov/nchhstp http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1201/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1201/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1210/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1210/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps13-1302/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps13-1302/index.html http://www.cdc.gov/hiv/topics/funding/PS14-1403/index.htm http://www.cdc.gov/hiv/topics/funding/PS14-1403/index.htm

/index.htm

• CDC-RFA- PS15-1502, “Comprehensive High-Impact HIV Prevention Projects for Community-Based Organizations” http://www.cdc.gov/hiv/policies/funding/announcements/ps15-1502/index.html

• CDC-RFA- PS15-1506, “Health Department Demonstration Projects to Reduce HIV Infections and Improve Engagement in HIV Medical Care among Men Who Have Sex with Men (MSM) and Transgender Persons” (in development).

• CDC-RFA-PS15-1510, "Training and Technical Assistance for Health Department Demonstration Projects for Comprehensive Prevention, Care, Behavioral, and Social Services for Men Who Have Sex with Men (MSM) of Color At Risk for and Living with HIV Infection" (in development).

Resources available online:

Centers for Disease Control and Prevention: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 Clinical Practice Guideline. Available at: http://www.cdc.gov/hiv/pdf/guidelines /PrEPguidelines2014.pdf

Centers for Disease Control and Prevention, Health Resources and Services Administration, National Institutes of Health, American Academy of HIV Medicine, Association of Nurses in AIDS Care, International Association of Providers of AIDS Care, the National Minority AIDS Council, and Urban Coalition for HIV/AIDS Prevention Services. Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States, 2014. Available at: http://stacks.cdc.gov/view/cdc/26062

Evidence-based and evidence-informed interventions are available at: http://www.cdc.gov/hiv/prevention /research/compendium/lrc/index.htmlhttps://www.effectiveinterventions.org/

Centers for Disease Control and Prevention: Sexually Transmitted Diseases Treatment Guidelines, 2010.

Available at: http://www.cdc.gov/std/treatment/2010/default.htm

Relevant citations:

Bradley H, Hall HI, Wolitski RJ, et al. Vital Signs: HIV Diagnosis, Care, and Treatment Among

Persons Living with HIV — United States, 2011. MMWR 2014;63(47):1113-1117.

Centers for Disease Control and Prevention. Estimated HIV incidence in the United States, 2007–2010. HIV Surveillance Supplemental Report 2012;17(No. 4). http://www.cdc.gov/hiv/topics/surveillance/resources/repor ts/#supplemental. Published December 2012. Accessed December 30, 2014.

State HIV Prevention Progress Report, 2014. Available at http://www.cdc.gov/hiv/policies/progressreports /index.html

Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365(6):493-505.

Dietz P.M., Krueger A.L., Wolitski R.J. et al. State HIV Prevention Progress Report, 2014 http://www.cdc.gov /hiv/policies/progressreports/index.html. Published August 2014. Accessed December 30, 2014.

Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363(27):2587-2599.

Johnson AS, Hall HI, Hu X, et al. Trends in Diagnoses of HIV Infection in the United States, 2002-2011.

JAMA. 2014; 312(4):432-434.

2. CDC Project Description http://www.cdc.gov/hiv/topics/funding/PS14-1403/index.htm http://www.cdc.gov/hiv/topics/funding/PS14-1403/index.htm http://www.cdc.gov/hiv/policies/funding/announcements/ps15-1502/index.html http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf http://stacks.cdc.gov/view/cdc/26062 http://www.cdc.gov/hiv/prevention/research/compendium/lrc/index.html http://www.cdc.gov/hiv/prevention/research/compendium/lrc/index.html https://www.effectiveinterventions.org/ http://www.cdc.gov/std/treatment/2010/default.htm http://www.cdc.gov/hiv/topics/surveillance/resources/reports//lsupplemental http://www.cdc.gov/hiv/topics/surveillance/resources/reports//lsupplemental http://www.cdc.gov/hiv/policies/progressreports/index.html http://www.cdc.gov/hiv/policies/progressreports/index.html http://www.cdc.gov/hiv/policies/progressreports/index.html http://www.cdc.gov/hiv/policies/progressreports/index.html

a. Approach

i. Purpose

To decrease the burden of HIV among MSM of color, this FOA supports health departments to collaborate with CBOs clinics or health care providers, and social services (i.e., mental health services, substance abuse services, housing programs, and job training or employment services) providers to implement models of comprehensive HIV prevention and care services for MSM of color who are at substantial risk for or living with HIV infection.

ii. Outcomes

Key outcomes to be expected by the end of the project period are illustrated in the logic model for the provision of comprehensive HIV prevention and care for MSM of color. Potential indicators that quantify these outcomes are described in Section b. Evaluation and Performance Measurement. Only project period outcomes are listed below.

Short term outcomes

Collaborative increases the number of MSM of color who are:

• Screened with lab-based 4th generation HIV tests

• Screened at least annually for HIV

• Screened more often if at substantial risk for HIV (e.g., every 3-6 months)

• Prescribed PrEP or nPEP if at substantial risk for HIV acquisition

• Provided appropriate clinical management if prescribed PrEP or nPEP

• Provided medication adherence support for PrEP or nPEP

• Immediately linked to care (within 7 days) and initiated on ARV treatment (within 14 days) if diagnosed with acute HIV

• Expediently linked to care (within 30 days) and initiated on ARV treatment (within 60 days) if diagnosed with established HIV

• Provided retention interventions if living with HIV and engaged in care

• Provided Data to Care re-engagement interventions if living with HIV and lost to care

• Provided medication adherence support/interventions if living with HIV

• Routinely screened for STDs

• Provided timely partner services

• Provided behavioral risk reduction services

• Routinely screened for behavioral health and social services needs

• Linked to behavioral health and social services

• Provided navigation to access HIV prevention, care, and behavioral health and social services

• Provided navigation to enroll in a health plan

Health department trained collaborative in:

• Healthcare billing and reimbursement procedures

• Provision of culturally competent HIV prevention and care for MSM of color

Health department supported collaborative to:

• Designate/hire staff to perform billing and reimbursement activities

• Implement billing for HIV tests, STD tests and treatment, and PrEP or nPEP services

• Designate/hire navigators to assist patients to access HIV prevention, care, and social services and to enroll in a health care plan

• Develop/implement tools to facilitate patient utilization of assistance programs for PrEP or nPEP medication costs

Medium term outcomes

Collaborative increased the number of MSM of color who are/have:

• Diagnosed with acute HIV among all HIV diagnoses

• Adherent to PrEP or nPEP medications

• Retained in HIV care

• Re-engaged in care

• Adherent to ARV treatment medications

• Received appropriate STD treatment

• Sex partners who received lab-based 4th generation HIV testing and linkage to HIV care and STD testing and treatment

• Received behavioral health and social services

• Enrolled in a health plan

Collaborative has:

• Expanded billing for HIV tests, STD tests and treatment, and laboratory tests required for PrEP and nPEP services

• Increased proportion of HIV tests that are reimbursed by a third party payer

• Increased proportion of STD tests and treatment and PrEP and nPEP clinical services that are reimbursed by a third party payer

• Developed business models for long term sustainability of HIV testing and treatment, STD testing, and PrEP or nPEP services beyond the project period

• Developed service models for provision of culturally competent HIV prevention and care for MSM of color

iii. Strategies and Activities

Comprehensive models of HIV prevention and care for MSM of color will be developed and implemented by a collaborative that is led by the jurisdiction’s health department and includes the following: health care providers (e.g., federally qualified health centers (FQHCs), FQHC Look-Alikes, other clinics, or health care providers); HIV care providers (e.g., clinics funded through the Ryan White HIV/AIDS Program (RWHAP clinics), other HIV care clinics, or HIV care providers); behavioral health and social services providers (i.e., mental health and substance abuse services, housing programs, and job training or employment services); and community based organizations (CBOs). Principles of high impact prevention should guide the selection and implementation of activities and strategies to focus on MSM of color at substantial risk for HIV infection (i.e., eligible for prevention with PrEP), and those living with HIV. MSM of color who are at risk for HIV acquisition (i.e., sexually active) but not eligible for or decline PrEP will be provided risk reduction interventions, partner services if diagnosed with an STD, re-testing for HIV and STDs in 3-6 months, and behavioral health and social services (Figure 3). The risk of HIV acquisition should be assessed at every encounter with an individual, and MSM of color at substantial risk of HIV acquisition should be offered PrEP when indicated by the risk assessment.

The health department will form, lead, and coordinate the collaborative; provide partner services; and provide cultural competency training for the collaborative that is supported by a separate FOA (CDC-RFA-PS15-1510). Depending on its capacity, the health department can also directly provide other required services and activities.

Screening for behavioral health and social services needs and linkages to behavioral health and social services, which acts as the means to address social determinants of health, are components of comprehensive models of prevention and care services. Behavioral health and social services that will be available to MSM of color at risk for HIV acquisition or living with HIV include mental health and substance abuse services (i.e., illicit drugs and alcohol treatment) including those funded by the Substance Abuse and Mental Health Services Administration (SAMHSA); housing programs including those supported by the Department of Housing and Urban Development (HUD); and job training or employment services including those supported by the Department of Labor (DOL).

HIV Prevention Services

The following 13 HIV prevention services that must be provided by the collaborative for MSM of color at substantial risk for HIV infection include:

1. HIV testing services that use lab-based 4th generation HIV tests

2. Assessment of indications for PrEP and nPEP

3. Provision of PrEP and nPEP

4. Adherence interventions for PrEP and nPEP

5. Immediate linkage to care, ARV treatment, and partner services for those diagnosed with acute HIV infection

6. Expedient linkage to care, ARV treatment, and partner services for those diagnosed with established HIV infection

7. STD screening and treatment

8. Partner services for patients with STDs

9. Behavioral risk reduction interventions

10. Screening for behavioral health and social services needs

11. Linkage to behavioral health and social services

12. Navigators to assist accessing HIV prevention and behavioral health and social services

13. Navigators to assist enrollment in a health plan

For each of the 13 required services (above), the following examples are provided for illustration. These examples are not a comprehensive list of all potential activities that might be developed in response to the required HIV prevention services.

HIV testing services include but are not limited to:

• Screening at least annually for HIV with lab-based 4th generation tests, and more frequently those at substantial risk for acquiring HIV infection (e.g., every 3–6 months)

PrEP and nPEP services and activities include but are not limited to:

• Identifying or creating educational materials and tools for nPEP and PrEP for providers and consumers

• Training of CBO staff, clinic staff, and health care providers in provision of nPEP and PrEP for HIV prevention

• Increasing awareness of MSM of color of PrEP and nPEP for HIV prevention

• Implementing screening tools for assessment of HIV risk, including self-assessment, to guide prevention activities

• Developing algorithms for offering PrEP based on risk assessment and STD test results

• Providing screening for PrEP indications as a routine procedure in conjunction with receiving HIV-negative tests results

• Developing protocols to transition patients from nPEP to PrEP if they have substantial ongoing risk of HIV acquisition

• Developing protocols to assure appropriate clinical management if prescribed PrEP or nPEP

• Developing the capacity to bill for laboratory tests required for PrEP and nPEP services

• Developing/implementing tools to facilitate patient utilization of assistance programs for PrEP or nPEP medication costs

HIV linkage and treatment services include but are not limited to:

• Developing protocols for immediately/expediently linking to care and initiating ARV treatment if diagnosed with acute/established HIV infection

• Developing protocols for provision of ARV treatment starter packs if diagnosed with acute or early HIV infection

STD screening and treatment services for MSM of color at risk of acquiring HIV include but are not limited to:

• Screening sexually active MSM of color at risk for HIV acquisition for STDs at least annually but more frequently (e.g., every 3–6 months) if at substantial risk for STD acquisition, including syphilis testing and genital and nongenital chlamydia and gonorrhea testing at anatomic sites of exposure using nucleic acid amplification tests (NAATs)

• Facilitating access to chlamydia and gonorrhea NAATs for nongenital specimens (e.g., rectal, oropharyngeal)

• Ensuring appropriate treatment of MSM of color diagnosed with syphilis, chlamydia, or gonorrhea

• Developing the capacity to bill for STD tests and treatment

Behavioral risk reduction intervention for MSM of color at risk of acquiring HIV includes but is not limited to:

• Providing free condoms, counseling, and behavioral interventions for all MSM of color

Activities for bebavioral health and social services for MSM of color at risk of acquiring HIV include but are not limited to:

• Developing/implementing tools to assess MSM of color needs and eligibility for behavioral health and social services

• Developing procedures to link MSM of color to behavioral health and social services

Figure 3. Summary of HIV prevention services for MSM of color at risk for HIV acquisition

* Alternative testing strategies with high sensitivity for acute HIV infection may be used (e.g., HIV-1 RNA testing)

† STD testing includes syphilis serology and chlamydia and gonorrhea NAATs at all anatomic sites of exposure

§ Behavioral health services include mental health and substance abuse services; social services include housing programs, and job training or employment services

HIV Care Services

The following 11 HIV care services that must be provided by the collaborative for MSM of color living with HIV infection include:

1. HIV primary care, including ARV treatment

2. Retention interventions

3. Re-engagement interventions

4. Adherence interventions

5. STD screening and treatment

6. Partner services

7. Behavioral risk reduction interventions

8. Screening patients for behavioral health and social services needs

9. Linkage to behavioral health and social services

10. Navigators to assist linking to care and accessing behavioral health and social services

11. Navigators to assist enrollment in a heath plan

The following are examples for some of the required services that may be provided for MSM of color living with HIV infection:

For each of the 11 required services (above), the following examples are provided for illustration. These examples are not a comprehensive list of all potential activities that might be developed in response to the required HIV care services.

Retention, re-engagement, and adherence interventions and activities include but are not limited to:

• Training of CBO staff, clinic staff, and health care providers in provision of retention, re-engagement, risk reduction, and adherence interventions

• Re-engaging in HIV care previously diagnosed MSM of color with HIV infection who have been named as partners in a partner services investigation

STD screening and treatment services for MSM of color living with HIV include but are not limited to:

• Screening sexually active MSM of color at risk for STDs at least annually but more frequently (e.g., every 3–6 months) if at substantial risk for STD acquisition, including syphilis testing and genital and nongenital chlamydia and gonorrhea testing at anatomic sites of exposure using nucleic acid amplification tests (NAATs)

• Facilitating access to chlamydia and gonorrhea NAATs for nongenital specimens (e.g., rectal, oropharyngeal)

• Ensuring appropriate treatment of MSM of color diagnosed with syphilis, chlamydia, or gonorrhea

• Developing the capacity to bill for STD tests and treatment

Partner services MSM of color living with HIV include but are not limited to:

• Providing immediate partner services for MSM of color diagnosed with acute HIV infection

• Providing partner services for MSM of color diagnosed with established HIV infection or STDs

• Implementing novel partner services that utilize the internet or mobile device apps

•Embedding health department partner services at the CBO and/or clinics that are providing HIV testing

Behavioral risk reduction intervention MSM of color living with HIV includes but is not limited to:

• Providing free condoms, counseling, and behavioral interventions for all MSM of color

Activities for behavioral health and social services for MSM of color living with HIV include but are not limited to:

• Developing/implementing tools to assess MSM of color needs and eligibility for behavioral health and social services

• Developing procedures to link MSM of color to behavioral health and social services

1.Collaborations

a. With CDC-funded programs:

Health department awardees are required to collaboratively partner with CDC. In addition, awardees should collaborate with other CDC-funded programs, where appropriate, to apply programmatic successes and lessons learned.

b. With organizations external to CDC:

For models of providing comprehensive HIV prevention and care services for MSM of color, it is important that health departments partner with HIV and other health care providers and organizations with experience or interest in providing nPEP and PrEP, STD screening and treatment, and reaching and engaging MSM of color in the jurisdiction. Health departments will create new or expand existing partnerships (as needed) with CBOs, LGBT organizations, FQHCs, RWHAP clinics, STD clinics, other clinics or health care providers, and behavioral health and social services providers (i.e., mental health and substance abuse services, housing programs, and job training or employment services) to form a collaborative, as described above.

Collaboratives should be proposed for the eligible MSA only (see "Eligibility" section below).

Collaborative CBOs must have the ability to serve as an access point to the community of MSM of color, and to effectively reach MSM of color to engage or re-engage them in prevention, care, and behavioral health and social services. Specific roles for CBOs in the collaborative might include raising community awareness of the project and services provided; conducting community outreach; and providing peer navigation to engage MSM of color in HIV prevention and care, and screen and link them to behavioral health and social services.

Many CBOs are suited to deliver interventions for medication adherence to PrEP or ARV treatment; retention in care; and behavioral risk reduction. Some CBOs might also provide clinical services such as lab-based 4th generation HIV testing and linkage to HIV care, STD screening and/or treatment, provision of PrEP and nPEP, or HIV primary care. CBOs might also have public health authority, granted by the health department, to conduct partner services or field investigations (Disease Intervention Specialist).

Clinics and health care providers must have the ability to provide HIV prevention and clinical care activities that the health department or CBO(s) do not offer, and might include: lab-based 4th generation HIV testing;

STD testing and treatment; prescribing PrEP and nPEP; clinical management of PrEP and nPEP patients;

linkage to HIV care; ARV treatment; HIV primary care; retention interventions; re-engagement interventions;

adherence interventions; behavioral risk reduction; screening for behavioral health and social services needs;

linkage to behavioral health and social services. Awardees may use funds to pay for STD testing. However, awardees should coordinate these services and seek payment first from other sources where available.

Possible payment sources include Medicaid, Medicare, and commercial health insurance.

The component agencies of the collaborative must include a health department as the primary awardee, and the health department will award at least 25% of these funds to one or more CBOs. Other partners within the collaborative should be included to ensure delivery of comprehensive HIV prevention, care, and behavioral health and social services for MSM of color. Only the health department and its CBO partner(s) in the collaborative will receive funding for this project; other collaborative partners are expected to have in place, or under development, mechanisms to support providing and billing for HIV prevention and care services. The health department will develop service agreements between collaborating partners.

Applicants must submit an MOU, MOA, or Letter of Support for each member of the collaborative. Each document should describe the proposed collaboration, specific activities, and responsiblities of the collaborative members for the intended outcomes and benefits for the overall proposed program. These documents should be on official letterhead, signed by the collaborating member, and electronically submitted with the application. Name the file using “MOU-Name of Collaborative Member”. If the name of the collaborative member is "HIV Service Organization" the file would be titled "MOU-HIV Service Organization". Upload it as a PDF file at www.grants.gov

CDC expects to collaborate with (although not provide funds to) the following partners:

• HHS partners: HRSA/HAB, HRSA/BPHC, SAMHSA, IHS, OMH, and OHAIDP

• U.S. government partners: HUD and DOL

To ensure culturally competent delivery of HIV prevention and care services for MSM of color, a curriculum and a training-of-trainers model for a certificate-based training program will be developed for health department awardees of this FOA through a separate FOA (CDC-RFA-PS15-1510). The health department http://www.grants.gov/ will in turn, train staff in the collaborative.

2. Target Populations

Health departments should focus their activities on gay, bisexual, and other MSM of color to achieve optimal impact of the activities in this FOA on the health of this population and health equity. Applicants should describe how the work plan would impact the local HIV epidemic among this population.

a. Inclusion

All applicants should design models of HIV prevention, care, and social services that are accessible and available to persons regardless of age, gender, race, ethnicity, sexual orientation, gender identity, or socio-economic status. Additionally, all applicants’ activities should result in measurable improvements in HIV prevention and care 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.

iv. Funding Strategy (for multi-component FOAs only)

Only the health department will receive funding for this project; health department awardees must provide at least 25% of the FOA award to the collaborative CBO(s). Also, 10% of the FOA award must be used for program evaluation.

Funding preferences will be given to jurisdictions that do not have similar and effective models in place; the intent of this FOA is not to provide more funding to programs that are established but to develop more models or test existing models in new places. Funding preferences will also consider geographic diversity.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC requires evaluation of the program and measurement of the awardee’s performance. Health department awardees will collect, and report to CDC, process and outcome data that are consistent with the logic model and strategies and activities presented above. Health department awardees will also be responsible for using evaluation data for continuous quality improvement of the program. The CDC evaluation and performance measurement strategy requires that awardees use 10% of the overall budget to support local program evaluation of funded activities, including: collaborate with CDC to develop evaluation plans and data collection activities as appropriate; participate in data collection activities as appropriate; submit progress reports; conduct real-time documentation and tracking of program activities using existing health department and partnering agency IT applications; and periodically enter and electronically submit to CDC data and other reporting information using a CDC approved system.

When possible, program effectiveness will be assessed using short and medium term outcome measures.

Where appropriate, outcomes can be calculated using existing HHS-supported data sources (e.g., HIV case surveillance and HIV testing). CDC will also require health department staff, and staff from partnering agencies (as appropriate), to collect and report data to measure additional program processes and outcomes.

Guidance on program monitoring and evaluation and performance measures will be provided by CDC on an ongoing basis throughout the project period.

ii. Applicant Evaluation and Performance Measurement Plan

In collaboration with the CDC, the awardee will design an evaluation and performance measurement plan that includes both outcome and process measures. The applicant, as well as CDC, may suggest additional performance measures. As part of the development of an evaluation and measurement plan, CDC and awardees will develop a core set of indicators post-award. Specific evaluation questions and performance measures, data sources, and program targets for the required 24 activities will be developed post-award in collaboration between the awardee and CDC.

The awardee will monitor program performance throughout the project period. Program outcome and process data will be submitted to CDC annually.

Implementation of lab-based 4th generation HIV testing

Outcome: Increased number of MSM of color residing in a jurisdiction who were screened for HIV infection with a lab-based 4th generation HIV test in 12 months

• Indicator: Number of MSM of color who were screened with a lab-based 4th generation HIV test over 12 months

Outcome: Increased percentage of newly diagnosed HIV infections in MSM of color that were diagnosed in the acute phase of infection

• Indicator: Percentage of MSM of color with newly diagnosed HIV infections that were in the acute phase of infection

Outcome: Increased percentage of HIV tests that were reimbursed by a third party payer

• Indicator: Percentage of lab-based 4th generation HIV tests of MSM of color at risk for HIV that were reimbursed by a third party payer

Implementation of nPEP

Outcome: Increased number of MSM of color with a risk event who presented within 72 hours of the event and were linked to an nPEP provider for clinical evaluation on the same day they presented

• Indicator: Number of MSM of color with a risk event who presented within 72 hours of the event and were linked to an nPEP provider for clinical evaluation on the same day they presented

Implementation of PrEP

Outcome: Increased number of MSM of color with a negative HIV test and at substantial risk for HIV who were linked to a PrEP provider for clinical evaluation

• Indicator: Number of MSM of color with a negative HIV test and at substantial risk for HIV who were linked to a PrEP provider for clinical evaluation

Linkage to care

Outcome: Increased percentage of MSM of color diagnosed with acute HIV infection who were linked to care within 7 days of diagnosis (immediate linkage)

• Indicator: Percentage of MSM of color diagnosed with acute HIV infection who were linked to care within 7 days of diagnosis

Outcome: Increased percentage of MSM of color diagnosed with acute HIV infection who were initiated on ART within 14 days of diagnosis (immediate treatment)

• Indicator: Percentage of MSM of color diagnosed with acute HIV infection who were initiated on ARVs within 14 days of diagnosis

Outcome: Increased percentage of MSM of color diagnosed with established HIV infection who were linked

Outcome: Increased percentage of MSM of color diagnosed with established HIV infection who were linked to care within 30 days of diagnosis (expedient linkage)

• Indicator: Percentage of MSM of color diagnosed with established HIV infection who were linked to care within 30 days of diagnosis

Outcome: Decreased median time to viral load suppression among all MSM of color diagnosed with acute/established HIV infection

• Indicator: Median time to viral load suppression among all MSM of color diagnosed with acute/established HIV infection

Retention interventions

Outcome: Increased percentage of MSM of color living with HIV who received retention interventions

• Indicator: Percentage of MSM of color living with HIV who received retention interventions and who subsequently had at least 1 medical visit in each 6 month period of a 12 month follow up with a minimum of 60 days between visits

Outcome: Increased percentage of MSM of color diagnosed with HIV who were retained in HIV medical care

• Indicator: Percentage of MSM of color living with HIV who had a least 1 HIV medical care visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between the first medical visit in the prior 6 month period and the last medical visit in the subsequent 6 month period among MSM of color living with HIV with at least 1 HIV medical care visit in the first 6 months of the 24-month measurement period.

• Indicator: Percentage of MSM of color living with HIV who received retention interventions and who subsequently received two or more CD4 or VL tests performed at least 3 months apart in the 12 month follow up period

Data to Care re-engagement interventions

Outcome: Increased percentage of MSM of color living with HIV who were re-engaged in careusing the Data to Care strategy

• Indicator: Percentage of MSM of color living with HIV identified as out of care using the Data to Care strategy

• Indicator: Percentage of MSM of color living with HIV identified as out of care who were subsequently contacted/received outreach by program staff

• Indicator: Percentage of MSM of color living with HIV identified as out of care who attended at least 1 clinic visit within 90 days of receiving outreach from program staff (re-engaged)

Adherence interventions:

Outcome: Increased percentage of MSM of color living with HIV who received adherence interventions and had HIV viral loads reduced to less than 200 copies/mL

• Indicator: Percentage of MSM of color who received adherence intervention(s) who had an HIV viral load less than 200 copies/mL at last HIV viral load test during the 12 month follow-up period

STD screening and treatment

Outcome: Increased percentage of MSM of color at risk for HIV acquisition or living with HIV who were screened for syphilis

• Indicator: Percentage of MSM of color at risk for HIV who were screened for syphilis

• Indicator: Percentage of MSM of color living with HIV who were screened for syphilis

Outcome: Increased percentage of MSM of color at risk for HIV acquisition or living with HIV who were diagnosed with syphilis and appropriately treated for syphilis

• Indicator: Percentage of MSM at risk for HIV acquisition who were diagnosed withsyphilis and appropriately treated for syphilis

• Indicator: Percentage of MSM living with HIV who were diagnosed with syphilis and appropriately treated

Outcome: Increased percentage of MSM of color at risk for or living with HIV who reported insertive/receptive anal/oral sex who were screened for chlamydia and gonorrhea by site of exposure:

• Indicator: Percentage of MSM at risk for HIV who reported insertive/receptive anal/oral sex who were screened for chlamydia and gonorrhea by site of exposure

• Indicator: Percentage of MSM living with HIV who reported insertive/receptive anal/oral sex who were screened for chlamydia and gonorrhea by site of exposure

Outcome: Increased percentage of MSM of color at risk for or living with HIV diagnosed with chlamydia and/or gonorrhea who were appropriately treated

• Indicator: Percentage of MSM at risk for HIV diagnosed with chlamydia and/or gonorrhea who were appropriately treated

• Indicator: Percentage of MSM living with HIV diagnosed with chlamydia and/or gonorrhea who were appropriately treated

Partner services

Outcome: Increased percentage of MSM of color who received timely partner service interviews after receiving a positive HIV test result

• Indicator: Percentage of MSM of color interviewed for partner services within 30 days of receiving a positive HIV test result

• Indicator: Percentage of partners of MSM of color who are newly diagnosed with HIV infection

• Indicator: Percentage of partners of MSM of color with newly diagnosed with HIV infection who are linked to care

• Indicator: Percentage of partners of MSM of color with previously diagnosed with HIV infection who are re-engaged in care

Risk reduction services

Outcome: Increased percentage of MSM of color at risk for or living with HIV who received risk reduction interventions

• Indicator: Percentage of MSM of color at risk for HIV acquisition who received risk reduction interventions

• Indicator: Percentage of MSM of color living with HIV acquisition who received risk reduction interventions

Behavioral Health and Social services

Outcome: Increased percentage of MSM of color at risk for HIV acquisition or living with HIV who were screened for behavioral health and social services needs (i.e., mental health and substance abuse services, housing programs, and job training or employment services))

• Indicator: Percentage of MSM of color at risk for HIV acquisition who were screened for behavioral health and social services needs

• Indicator: Percentage of MSM of color living with HIV who were screened for behavioral health and social services needs

Outcome: Increased percentage of MSM of color at risk for HIV acquisition or living with HIV who needed any specified behavioral and social service (i.e., mental health services, substance abuse services, housing programs, job training, employment services) and were linked to the service programs, job training, employment services) and were linked to the service

• Indicator: Percentage of MSM of color at risk for HIV acquisition who needed any specified behavior and social service and were linked to the service

• Indicator: Percentage of MSM of color living with HIV who needed any specified behavioral and social service and were linked to the service

Enrollment in a health plan

Outcome: Increased percentage of MSM of color at risk for HIV acquisition or living with HIV who needed health insurance and were linked to the service

• Indicator: Percentage of MSM of color at risk for HIV acquisition who needed health insurance and were linked to the service

Indicator: Percentage of MSM of color living with HIV who needed health insurance and were linked to the service

c. Organizational Capacity of Awardees to Execute the Approach

The applicant should describe its…