Revision Foa_Content_of_CDC-RFA-GH-24-0100.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Delivery of Quality and Equitable Public Health Services for Prevention, Testing, Care, and Treatment of HIV in Jamaica and Trinidad and Tobago under PEPFAR

CDC-RFA-GH-24-0100

02/27/2024

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH-24-0100. 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) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Strengthening Delivery of Quality and Equitable Public Health Services for Prevention, Testing, Care, and Treatment of HIV in Jamaica and Trinidad and Tobago under PEPFAR C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

Applicants should note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO or for any CDC PEPFAR FY24 NOFO. Applicants should not submit LOIs.

Amendment I: Questions and Answers (Q&A) and Additional Updates https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

The purpose of this amendment is to include the updates as listed below.

• The amendment includes questions and answers (Q&A) in Section H. Other Information.

• CDC has retired the Risk Assessment Questionnaire Requirement and applicants are no longer required to submit the CDC Risk Questionnaire as part of their NOFO application.

CDC continues to conduct the review of risk posed by applicants described in Phase III Review and may ask for additional information prior to the award based on the results of the review. Risk Questionnaires that are submitted will not be included in this risk review.

• In F. Award Administration Information, 2. Administrative and National Policy Requirements, CDC has added AR-38: Health Information Technology (IT) Interoperability to the list of Organization Specific Administrative Requirements.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0100

E. Assistance Listings Number:

93.067 F. Dates:

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

2. Due Date for Applications:

02/27/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph This NOFO is intended to deliver quality and equitable public health services for HIV prevention, testing, care, and treatment to reach UNAIDS 95-95-95 targets in Jamaica and Trinidad & Tobago. Efforts plan to address HIV prevention, case finding, linkage, retention, and viral suppression gaps with a focus on key and priority populations. Integrated support to increase the uptake of HIV testing, strengthen linkage to care, improve retention on antiretroviral therapy (ART) and increase viral load coverage and suppression among people living with HIV (PLHIV) is key. Activities should include:

• Effective HIV/STI screening and testing services including HIV Self-Testing (HIVST), Index Testing, provider-initiated HIV testing and counseling and Social Network Strategy

• Demand creation for HIV prevention and testing services

• Biomedical and other prevention strategies (e.g., Pre-exposure prophylaxis (PrEP) and

Post-exposure prophylaxis (PEP) for eligible clients according to national guidelines at health facilities, including youth appropriate clinics

• Improve enabling environment for non-stigmatizing and non-discriminatory provision of health care services

• Fidelity in implementation of return and recovery interventions

• Person-centered application of retention measures and antiretroviral (ARV) regimes.

The recipient should prioritize service quality data for decision-making and program improvement.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$0 The Approximate Project Period of Performance Funding/Estimated Total Funding for the Total 5 year Project Period is None. The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for years 2-5 will be set at continuation.

e. Average One Year Award Amount:

$4,500,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $4,500,000. The expected number of awards is 1. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 30, 2024

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO 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 Since the inception of PEPFAR in 2003, great progress has been made to combat the global HIV and TB epidemics resulting in over 13.3 million adults and children on ART after 20 years of intensive funding and program implementation.

PEPFAR is focusing on sustainability and partnerships with key and vulnerable populations (KP), and on using data for impact. More than ever, there is a need for implementing and enforcing PEPFAR’s support for global health activities to optimize patient offerings in prevention, testing, treatment, and care.

This NOFO serves as a continuation of CDC’s support in Jamaica and Trinidad & Tobago to reach UNAIDS 95-95-95 targets. In Jamaica, 46% of adolescents and youths (aged 15-24) living with HIV know their status compared to 90% in older PLHIV (over 50 years old). The inequities in the HIV epidemic among KP present additional challenges to reach epidemic control. The HIV prevalence among men who have sex with men (MSM) (29%) and transgender women (TGW) (51%) is significantly higher than that of the general population (GP) (1.2%). There is an increasing need for reduction in stigma and discrimination and the improvement of an enabling environment for provision of critical services to all PLHIV.

Moreover, retention of PLHIV in both Jamaica and Trinidad & Tobago is the major challenge, with the second 95 stunted at 58%. Psychosocial challenges in all age groups and subpopulations persist as the main issue, with social priorities in the working age group (19-54 years) emerging as a pull factor from care. Continuation of differentiated service delivery options as well as improved quality of the clinical experience are evidenced-based approaches to address clinic-dependent retention barriers.

The recipient of this NOFO will assist the host country to use evidence-based, data-driven approaches towards the achievement of epidemic control. This will support the following strategies:

• Enhance implementation of comprehensive HIV prevention interventions across all populations over the age of 16

• Use evidence-based practices to implement efficient case finding strategies for general, vulnerable, and KP

• Implement status neutral testing services throughout the region to include effective pathways for all persons being tested to either appropriate prevention or treatment services

• Support community led monitoring services, including community involvement in the design of HIV services

• Strengthen National Human Resources for Health through support of health care workers (HCWs) and support of staff to implement competent client-centered prevention, testing, care, and treatment services

• Institutionalize linkage to care strategies

• Support and develop interventions to increase ART coverage, retention, and viral suppression, including those for mental health, psychosocial support and adherence to human rights

Evidence based international best practices and policies based on World Health Organization (WHO) and PEPFAR guidance will be used to help accelerate progress. Disaggregated epidemiological and program data, combined with key survey and surveillance results will serve as the driver for targeted interventions with rapid evidence-based course adjustments.

b. Statutory Authorities This program is authorized under Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601, et seq.] and Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

The President’s Emergency Plan for AIDS Relief (PEPFAR) has called for immediate, comprehensive and evidence-based action to turn the tide of global HIV/AIDS. The overarching purpose of this NOFO is to fund activities to prevent or control disease or injury and improve health, or to improve a public health program or service.

c. Healthy People 2030 N/A

d. Other National Public Health Priorities and Strategies Under the leadership of the Global Health Security and Diplomacy Bureau (GHSD Bureau), as part of PEPFAR, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works in partnership with host country governments and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan in a manner consistent with the purposes of this NOFO. Goals and priorities include the following:

• Reducing the prevention and treatment gaps for adolescent girls and young women (AGYW), children, and key populations (KPs);

• Strengthening national and local programmatic, financial, and community leadership;

• Designing new partnerships with key private, public, and multi sector entities that can complement existing programs and expand reach;

• Utilizing the PEPFAR platform for broader disease surveillance and public health programming, consistent with the PEPFAR legislative and funding authority;

• Investing in the scale-up of cutting edge behavioral and implementation science to bend the curve on new infections;

• Improving the care and treatment of HIV/AIDS, sexually transmitted infections (STIs), and related opportunistic infections by improving STI management; enhancing laboratory diagnostic capacity and the care and treatment of opportunistic infections; interventions for intercurrent diseases impacting HIV infected patients including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART);

• Strengthening the capacity of countries to collect, use, and share surveillance data and manage national HIV/AIDS programs by expanding HIV/STI/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease monitoring, and HIV screening for blood safety; and

• Developing, validating, and/or evaluating public health programs to inform, improve, and target appropriate interventions, as related to the prevention, care and treatment of HIV/AIDS, TB, and opportunistic infections.

In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among relevant partners. Recipients may be requested to participate in the following programmatic activities:

• Scale-up evidence-based programs to identify and close the major HIV gaps among AGYW, children, and KPs;

• Increase impact through strategic coordination and integration;

• Strengthen and leverage key multilateral organizations, global health partnerships, and private sector engagement;

• Encourage country ownership and invest in country-led plans, putting our national and local partners in the lead and actively enabling their growth through design of the program at all phases;

• Build sustainability through investments in health systems;

• Enhance health equity and reduce disparities in access to and uptake of HIV services;

• Improve performance metrics, monitoring and evaluation and the quality of related data;

and

• Promote research, development, and innovation to develop a body of knowledge, enhance awareness and increase the skills and abilities of stakeholders (research is not supported by this NOFO).

PEPFAR defines national HIV epidemic control as the point at which the number of new infections falls below the declining number of deaths among people living with HIV (PLHIV).

This definition of epidemic control does not suggest near-term elimination or eradication of HIV as may be possible with other infectious diseases, but rather suggests a decline of HIV-infected persons in a population, achieved through the reduction of new HIV infections when mortality among PLHIV is steady or declining, consistent with natural aging. Critically, however, a country will not be able to maintain epidemic control if program efforts are not sufficiently sustained and new infections are allowed to rebound or death rates to increase.

In addition to the specific activities listed in the Strategies and Activities section of this NOFO, all CDC PEPFAR cooperative agreements resulting from this NOFO may address the following activities, where and when appropriate, that focus U.S. government resources and activities toward achieving and sustaining the HIV/AIDS epidemic:

• Optimize HIV testing and treatment strategies to reach undiagnosed populations living with HIV, especially young adults, men, and KP. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response, including efforts to reduce or remove evidenced barriers to services such as stigma and discrimination and inequitable gender norms. Responding to recent infections or ongoing patterns of transmission will be prioritized.

• Focus on prevention among children, adolescents, young adults, and members of vulnerable and key populations.

• Support surveillance activities and programs, along with information systems, that improve understanding of HIV epidemiology, help identify inequities and remaining gaps (e.g., societal impediments to HIV services), and inform future programming.

• Support efforts to maintain quality for laboratory systems and activities, including diagnostics and viral load measurement.

• Actively use epidemiologic, program, and financial/cost data to ensure implementation of high quality, cost-effective programs to improve partner performance and increase epidemiologic impact.

• Support country-led, sustainable programming by working with and implementing activities through local partners, including faith communities and faith-based organizations (FBOs), HIV network organizations and community-based organizations (CBOs) directly servicing communities and populations at-risk and most affected by HIV to build local capacity.

• Strengthen programmatic, financial, and community contributions by partner governments in the HIV/AIDS response.

• Support activities, interventions, and programs (e.g., including those intended to reduce or remove evidenced societal impediments to services such as stigma, discrimination, and inequitable gender norms) to find, treat, and prevent TB among PLHIV and to identify and treat HIV among people infected with TB.

• Support efforts to prevent, detect, respond, and treat infectious and non-infectious diseases that impact PLHIV and populations affected by HIV.

Any activities outside of HIV or TB activities will be consistent with the direction set forth in PEPFAR’s Five-Year Strategy, PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance, annual COPs/ROPs, or other similar forthcoming strategy, guidance, or planning documents as may be consistent with applicable law.

Geographic prioritization may change over the course of the period of performance based on the burden of disease and changing program and PEPFAR priorities.

If the scope of activities to be conducted by the recipient(s) of funds under this NOFO includes work with KP, the recipient(s) will be expected to collaborate with KP organizations in the design and delivery of appropriate optimal and quality HIV services to KP.

Any Personally Identifiable Information (PII) collected for continuity of service provision should be managed in a manner that ultimately protects individual-level data to the extent allowed by applicable law.

In addition, PEPFAR is committed to protecting children from abuse, exploitation, and neglect in order to decrease their vulnerability to HIV/AIDS. Consistent with underlying authorities, PEPFAR seeks to ensure that children and youth obtaining services through PEPFAR programming are also protected from abuse, exploitation, and neglect in CDC PEPFAR-supported programs.

To that end, because activities to be funded under this NOFO may involve children or personnel coming into contact with children, Recipients of CDC PEPFAR funds agree to ensure compliance with host country and local child welfare and protection legislation or international standards, whichever gives greater protection, and with U.S. law, where applicable. Further, Recipients of CDC PEPFAR funding are strongly encouraged to: 1) have in place policies and procedures that prohibit recipient personnel from engaging in child abuse, exploitation, or neglect; 2) consider child safeguarding in project planning and implementation to determine potential risks to children that are associated with project activities and operations; 3) apply measures to reduce the risk of child abuse, exploitation, or neglect, including, but not limited to, limiting unsupervised interactions with children; prohibiting exposure to pornography; and complying with applicable laws, regulations, or customs regarding the photographing, filming, or other image-generating activities of children; 4) promote child-safe screening procedures for personnel, particularly personnel whose work brings them in direct contact with children; and 5) have a process for ensuring that personnel and others recognize child abuse, exploitation, or neglect, report allegations, investigate and manage allegations, and take appropriate action in response to such allegations. It is also strongly encouraged that Recipients include the above provisions in any applicable code of conduct for its personnel implementing PEPFAR-funded activities.

In its work with partners, CDC seeks to help control HIV epidemics and to achieve and maintain low levels of HIV incidence and mortality. Now and in the future, viable, capable, durable, and successful local partners will play an important role in achieving and sustaining control of national HIV epidemics. To that end, CDC strongly encourages direct applications from local organizations (i.e., institutions located, registered, and managed in the country and/or sub-region where work occurs and led by national of that country and/or sub-region). U.S.-based partners working in international settings also offer unique capabilities and will continue to make important contributions. Partnerships between local organizations and U.S.-based organizations may also offer benefits and are encouraged in such cases.

This NOFO is only for non-research activities supported by CDC. Recipients may not use funds for research. Certain activities that may require human subjects review due to institutional requirements but that are generally considered not to constitute research (e.g., formative assessments, surveys, disease surveillance, program monitoring and evaluation, field evaluation of diagnostic tests, etc.) may be funded through this mechanism. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

e. Relevant Work This NOFO builds upon the previous NOFO (GH19-1951), which focuses on PEPFAR-supported countries and PEPFAR-prescribed activities. This NOFO will also build on previous prevention, care & treatment (PCT) strategies and interventions, like COP 19's “reboot” strategy, PEPFAR's 5 by 3 strategy and the Caribbean Regional Program's ROP 23 strategy, aimed at testing, retention, and suppression gaps in service provision towards achieving epidemic control.

Specifically, this NOFO builds on the following past and/or current CDC-funded activities:

• Finding the Undiagnosed, Linking and Enrolling Newly Diagnosed o Strengthen contact investigations o Improve implementation of provider-initiated testing and counseling (PITC) o Strengthening status neutral testing, with equal referral and capacity building support for clients testing both HIV positive (intervention) and HIV negative (prevention).

o Supporting the roll out of HIV PrEP, including media messaging, supporting HCWs with recruitment, and reinforcement of clinical guidelines for initiation.

• Supporting ART Adherence o Support targeted interventions to retain all patients, support adherence and sustained viral suppression o Support potential sites for expansion of HIV care, including sites not traditionally included.

o Provide clinical mentoring services to impact treatment initiation, adherence, and viral suppression o Support continuous quality improvement (CQI) o Provide peer support for patient retention, care navigation and linkage to care and treatment

• Achieving Sustained Viral Load Suppression (VLS) o Develop and strengthen strategies to decentralize and support VL sampling and sample preparation https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102 o Develop interventions to improve VL literacy among care providers and enrolled patients o Develop plans to strengthen management, including criteria for referral, in areas of Mental Health, social work and enhanced adherence support

• Strengthening Laboratory services and systems o Strengthen onsite phlebotomy and sample transport services o Optimize the laboratory network to support the HIV care and treatment program in Jamaica

According to the HIV cascade in Jamaica, of Jamaica’s estimated 30,489 PLHIV, 55% are undiagnosed. Of the estimated 16,774 undiagnosed PLHIV, 25% are estimated to be MSM (n=4,224), 31% are women (n=5,204), and 44% are non-MSM or “men of unconfirmed risk” (n=7,284). A complementary review of case-finding approaches has been completed to identify programmatic opportunities for reaching the undiagnosed. With this NOFO, PEPFAR’s assistance will focus on the sustained achievement of HIV epidemic control in Jamaica with support for Trinidad & Tobago.

While prevention has been the pillar and cornerstone of the national HIV response since the epidemic began in the 1980’s, the introduction of biomedical prevention strategies was initially piloted in Jamaica in 2017 with a significantly low uptake of PrEP in Jamaica from populations who would benefit. PrEP is not available in Trinidad & Tobago. In addition, despite the progress towards the first 95 in both countries, the remaining gaps across the HIV cascade demonstrate the need for robust, targeted, and innovative case finding approaches to close the gaps in targeted groups including adolescents, youth, older males and females, and KP.

After accounting for unreported deaths amongst diagnosed PLHIV, approximately 8,232 are diagnosed but not on ART. A major programmatic gap is that over 8,000 PLHIV who were previously diagnosed are not presently on ART. This subset of PLHIV consists of three groups:

those never linked to treatment services (4,440); those who were previously linked and are now lost to follow up (4,624); and those who are in care but not on ART (328). Entry to care and return to care activities have benefited from surge and routinized approaches, and protocols exist for continuous return and recovery. Sub-population targeted activities have been established to reach males, young women and KP with varying success. One-third of the estimated 30,489 PLHIV in Jamaica are currently on treatment. Males account for 60% of estimated PLHIV but only 45% of ART patients. Consequently, the “ART coverage gap” is greater amongst males, with gender disparities consistent across all age groups. Tailored strategies are needed to increase the number of males newly initiated and retained on ART.

Through this NOFO, PEPFAR will work assiduously to resolve these gaps and to ensure that strategies and resources are aligned to serve the populations and groups most in need, with a major rethinking of the overall strategy for the national response by aggressively addressing key barriers to testing, linkage to care, treatment initiation, retention, and viral suppression through:

1) finding the undiagnosed persons; 2) linking those diagnosed but not on ART to treatment; and

3) achieving viral suppression for those on ART.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes

Intermediate

Long-Term

Strategy 1:

Strengthen comprehensive HIV prevention and testing services to GP, PP, adolescent girls, and young women (AGYW), and KP

Strategy 2:

Provide targeted support for linkage, return to care, retention, and viral suppression activities (e.g., addressing patient literacy barriers, HCW/site staff barriers, etc.)

Increased uptake of prevention services including biomedical prevention among GP, PP, AGYW, and

KP

Increased access and uptake of evidence-based, cost-effective, sustainable, and innovative HIV case finding interventions

Increased linkage to same-day ART initiation or rapid ART initiation for

PLHIV

Improved knowledge of HIV status among

GP

Reduced patient challenges in accessing and accepting care

Improved ARV supply

Increased adherence support to PLHIV

Sustained competencies of the care team in

Increased coverage of HIV prevention and testing services among KP, PP, AGYW and

GP

Reduced HIV related stigma and discrimination among HCWIncreased knowledge of HIV status and linkage to stigma free, person-centered treatment facilities

Improved quality of HIV and STI prevention and testing service delivery provided by HCWs

Increased use of high-quality HIV data for program planning and decision-making

Reduced interruption in care

Increased retention of PLHIV on appropriate ART

Reduced structural barriers to care

Reduced HIV incidence among adolescents and youths, GP, PP, AGYW and KP

Improved supportive environments for all clients seeking HIV/STI services in public facilities

Increased viral suppression among

PLHIV

Reduced incidence of opportunistic infections, TB, and HIV Cause specific mortality

Strategies and Activities

Short-Term

Intermediate

Long-Term administering HIV treatment and support

Improved health system capacity to provide care and support to PLHIV

i. Purpose The purpose of this NOFO is to increase access to and delivery of HIV prevention, testing, treatment and retention services for adolescents, adults, and KPs, and to protect the rights and dignity of all PLHIV in Jamaica and Trinidad & Tobago to achieve and sustain HIV epidemic control, in line with PEPFAR, and national plans, policies, and priorities. The goal of enhancing prevention, care and treatment capacity is to reduce the number of new infections while maintaining the health and dignity of PLHIV.

ii. Outcomes CDC may require or allow applicants to propose additional related project period outcomes other than those identified in the NOFO.

Short-Term Outcomes:

• Increased uptake of prevention services including biomedical prevention among GP, PP, AGYW, and KP

• Increased access and uptake of evidence-based, cost-effective, sustainable, and innovative HIV case finding interventions

• Increased linkage to same-day ART initiation or rapid ART initiation for PLHIV

• Improved knowledge of HIV status among GP

• Reduced patient challenges in accessing and accepting care o Reduced patient challenges in accessing and accepting care include, but are not limited to increased knowledge and understanding of modifiable patient barriers to care, enhanced PLHIV knowledge on care access points and services, and social support provided for PLHIV limited by financial/economic barriers

• Sustained competencies of the care team in administering HIV treatment and support o Maintained care team competence in administering HIV treatment and support includes, but is not limited to initial and refresher (as necessary) trainings in Clinical Management conducted, appropriate personnel recruited for treatment, care, and support activities, provision of supervision as indicated, and improved soft skills in engaging with clients

Intermediate Outcomes:

• Increased coverage of HIV prevention and testing services among KP, PP, AGYW and

GP

• Reduced HIV related stigma and discrimination among HCW

• Increased knowledge of HIV status and linkage to stigma free, person-centered treatment facilities

• Improved quality of HIV and STI prevention and testing service delivery provided by

HCWs

• Increased use of high-quality HIV data for program planning and decision-making

• Reduced interruption in care o Reduced interruption in care includes, but is not limited to adherence support provided for clients as indicated, and implemented, refined, and faithfully practiced protocols for recovery and retention of PLHIV clients

• Increased retention of PLHIV on appropriate ART

• Improved health system capacity to provide care and support to PLHIV o Improved health system to provide care and support to PLHIV includes, but is not limited to increased awareness of staff in need for quality care for PLHIV, enhanced patient trust in health system, and improved availability and use of equipment, hardware, and software in provision of care

Long-Term Outcomes:

• Reduced HIV incidence among adolescents and youths, GP, PP, AGYW and KP

• Improved supportive environments for all clients seeking HIV/STI services in public facilities

iii. Strategies and Activities CDC may require or allow applicants to propose additional related strategies and activities other than those identified in the NOFO to achieve the expected Outcomes.

Strategy 1: Strengthen comprehensive HIV prevention and testing services to GP, PP, AGYW and KP

• Build site level and leadership staff capacity to improve prevention and testing services

• Implement innovative prevention and testing services to improve prevention and case finding outcomes

• Provide supportive supervision to facility staff to improve the quality of services delivered by facility

• Conduct continuous quality improvement interventions to support prevention and testing services

• Provide population appropriate prevention and testing services for key and vulnerable groups

Strategy 2: Provide targeted support for linkage, return to care, retention, and viral suppression activities (e.g., addressing patient literacy barriers, HCW/site staff barriers, etc.)

• Train HCW in necessary competences for administering quality, comprehensive care

• Design appropriate guidance, tools, SOPS, and mechanisms to address gaps

• Conduct program evaluation as indicated to delineate existing and emerging limitations to program success

• Conduct public education as indicated to increase awareness and influence behavior change

• Recruit / Subcontract as indicated to address staffing needs

In furtherance of the underlying purposes of this NOFO, Recipient is expected to provide copies of and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders, including HHS/CDC, for appropriate use consistent with underlying authorities.

1. Collaborations

a. With other CDC projects and CDC-funded organizations:

The recipient will be expected to collaborate with all CDC – Caribbean Regional Office (CRO) staff and headquarters staff, as well as CDC-funded implementing partners and government ministries including Ministries of Health and Wellness and the Ministry of Gender Affairs in Jamaica. Collaborations as needed will also occur with other CDC-supported international and regional public health organizations within the region such as UNAIDS, WHO/PAHO, and

UNICEF.

b. With organizations not funded by CDC:

The recipient will be expected to collaborate with:

• United States Government (USG): Other USG agencies, namely United States Agency for International Development (USAID) and Health Resources and Service Administration (HRSA) who provide national program support to Jamaica and Trinidad & Tobago. Collaboration will be needed to facilitate efforts.

• Multilateral - Global Fund: The recipient will work with multilaterals at varied levels, but mainly at the regional and site levels, collaboratively developing strategies and implementation plans, to inform national protocol. The expectation is that this is done in a collaborative spirit.

2. Population(s) of Focus The population(s) of focus for this NOFO include:

• GP (over the age of 16 years old)

• KP (MSM, TGW and sex partners)

• Other Priority Populations (AGYW, Adolescent Boys and Young Men, Youth, sero-different couples, PLHIV)

• Health care providers and support staff

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

In an effort to assure that activities funded through this NOFO (1) affirm and advance, as appropriate, the role of health equity and an equitable, diverse, and inclusive workforce as core principles, and (2) advance the reduction of stigma and discrimination through the promotion, consistent with applicable laws, of civil and human rights to improve the health outcomes of persons at risk of, or living with, HIV and/or TB infection, CDC PEPFAR awards resulting from this NOFO may address the following activities, where and when appropriate:

• Community involvement in the design, implementation, and monitoring of HIV and TB services.

• Training for implementing partners involved in the design, implementation, and/or monitoring of activities on stigma, discrimination, gender equitable norms, human rights, and community engagement to minimize the likelihood for activities to unintentionally increase stigma and discrimination directed towards PLHIV, people with TB, and other

KP.

• Programs to address evidenced health disparities and social barriers (e.g., HIV-related stigma) to HIV and TB services.

• Use of data to monitor disparities and implement strategies to improve access, service use, and outcomes.

iv. Funding Strategy Applicants to this NOFO are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount. Applications must not exceed this amount.

Component Funding: It is required that all PEPFAR-funded cooperative agreements be formulated for component funding. A component is a discrete set of activities with an associated budget. CDC will use component funding to provide funding for activities proposed in an application that received merit review but were not selected for funding in the initial award (i.e., at the onset of budget period 1) but may be funded at a later point in the budget period as programmatically necessary and as funding becomes available. Please review the following key points about component funding:

• Component funding must be setup at the time of the application. While preparing the application, applicants should review the expectations listed in the NOFO for Year 1 activities and group them under the anticipated components listed below. Only activities planned for Year 1 should be grouped into components; applicants do not need to group activities in the high-level plan for the subsequent years 2-5 of the award into components. Funding amounts and components for years 2-5 will be determined at continuation.

• Each component must be a discrete set of activities with an associated budget.

Distinguishable component budget narratives are required. Setting up components based on time (i.e., quarterly) is an appropriate distinction of activities, provided activities are clearly outlined.

• Applicants should submit the anticipated components on an SF-424A form as part of their application which shows all components for the budget period. The amounts should exactly match what is being requested for funding. Each component has its own approved amount and cannot be funded above the established amount. The combined total of all components must total the requested amount.

• If more than 4 components are proposed, multiple SF-424As will be needed. Applicants may include the first 4 components on one SF-424A form and the remaining components on a second SF-424A form. Applicants may download additional SF-424A forms and upload them as PDFs under “Budget Narrative Attachment Form” or “Other Attachments Form.” These should be clearly labeled for easy identification and included in the Table of Contents for the entire submission.

• If possible, applicants are encouraged to submit a separate budget justification for each component, but it is not a requirement. Applicants will not be deemed incomplete if separate budget justifications are not provided with the submission. A separate budget justification will ultimately be required for all components that are funded.

• Any component that is not funded at the time of a new award may be deemed “Approved but Unfunded (ABU)”. There is no guarantee that all components will be funded in a budget period as ABU components are subject to the availability of funds and the underlying legal authority for the work.

o Components may not be awarded in order. All ABU components are eligible to receive funding once (and if) funds become available.

o If funding becomes available, multiple components can be funded through the same funding action (single NOA).

o If funding is awarded for an amount less than the ABU component approved amount, it is not possible to fund the difference at a later time. Components can only be funded once.

• If, during the funding confirmation, the Program Office approves a budget that differs from what was submitted at the time of application (reflected in the budget markup), a revised budget may be required in addition to the technical review responses. If required, the revised budget is due within thirty (30) days of the start of the budget period. If required, technical review responses will also be due within thirty (30) days of the start of the budget period and must be submitted separately from revised budget applications.

Future funding for ABU components will not be awarded until a revised budget, if required, is submitted and approved by CDC.

• Once components are awarded, funds cannot be redirected between components.

However, funds may be redirected within a component between object class categories.

It is critical to ensure accountability, transparency, and programmatic performance of all U.S.

taxpayer dollars. When developing the annual work plan, please be advised that the annual COP/ROP guidance requires that CDC take decisive action if an implementing partner is underperforming programmatically during any quarter of a fiscal year.

Applicants are encouraged to consider the following in the development of their budgets and budget narratives:

For Year 1, CDC anticipates an Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award of $4,500,000 with the below listed components:

• Component 1 – COP Q1 Targets/Activities;

• Component 2 – COP Q2 Targets/Activities;

• Component 3 – COP Q3 Targets/Activities;

• Component 4 – COP Q4 Targets/Activities;

• Component 5 – COP Additional Targets/Activities;

• Component 6 – Emerging Public Health Priorities (EPHP) 1

• Component 7 – EPHP 2

Applicants must specify a descriptive title for each corresponding column shown on the SF- 424A, followed by the total (cumulative) in the column to the far right of the SF-424A.

Applicants are encouraged to use the components listed above, but may propose alternative budget components so long as the general component funding guidance is followed.

Funding provided under this NOFO is subject to the availability of funds. The total number of years for which federal support has been programmatically approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. All future year funding will be based on satisfactory programmatic progress and the availability of funds.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC expects that the routine performance data is reviewed, cleaned, and used for program management. To this effect, the recipient should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient, a minimum of 5% of funds should be allocated for monitoring activities and 10%of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Some anticipated PEPFAR (MER) and non-MER indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. Applicants should also propose any additional relevant PEPFAR MER and non-MER indicators as part of their initial Evaluation and Performance Measurement Strategy.

Applicants should note that these may be adjusted, or new targets and indicators may be identified in subsequent years based on implementation of HIV/AIDS epidemic control strategies and program priorities. Any gaps or unmet needs not fulfilled in the first year may affect the targets of the subsequent years.

Unless otherwise indicated, the reporting periods for MER indicators will mirror the PEPFAR MER indicator reporting frequency (quarterly, semi-annually, and annually). Additional information regarding MER reporting is included in the MER Guidance and resource materials, available at the following link (copy/paste into web browser to access):

https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides.

PEPFAR MER Process and Outcome Measures:

• HTS_SELF: Number of individual to whom HIVST kits distributed [Target: 3000;

Reporting Frequency: Quarterly]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results [Target: 1460; Reporting Frequency: Quarterly] https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• HTS_TST_POS: Number of individuals who received HIV Testing Services (HTS) and received a HIV positive test result [Target: 147; Reporting Frequency: Quarterly]

• HTS_TST_NEG: Number of individuals who received HIV Testing Services (HTS) and received a negative test result [Target: 1313; Reporting Frequency: Quarterly]

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results [Target: 1384; Reporting Frequency: Quarterly]

• PrEP_CT: Number of individuals, excluding those newly enrolled, that return for a follow-up visit or re-initiation visit to receive pre-exposure prophylaxis (PrEP) to prevent HIV during the reporting period [Target: 38; Reporting Frequency: Quarterly]

• PrEP_NEW: Number of individuals who were newly enrolled on pre-exposure prophylaxis (PrEP) to prevent HIV infection in the reporting period [Target: 162;

Reporting Frequency: Quarterly]

• Tx_New: Number of adults and children newly enrolled on antiretroviral therapy (ART).

[Target: 284; Reporting Frequency: Quarterly]

• TX_CURR: Number of adults and children with HIV infection receiving antiretroviral therapy (ART) [Target: 5843; Reporting Frequency: Quarterly] o Reported as the number of adults and children with HIV infection receiving ART

• TX_PVLS: Percentage of ART patients with a suppressed viral load (VL) result (<1000 copies/ml) documented in the medical or laboratory records/laboratory information systems (LIS) within the past 12 months o TX_PVLS (N): Number of ART patients with suppressed VL results (<1,000 copies/ml) documented in the medical or laboratory records/LIS within the past 12 months [Target: 4856; Reporting Frequency: Quarterly] o TX_PVLS (D):Number of ART patients with a VL result documented in the medical or laboratory records/LIS within the past 12 months. [Target: 5113;

Reporting Frequency: Quarterly]

• TX_ML: Number of ART patients with no clinical contact since their last expected contact [Target: Not assigned; Reporting Frequency: Quarterly]

• TX_RTT: Number of ART patients who experienced an interruption in treatment (IIT) during any previous reporting period, who successfully restarted ARVs within the reporting period and remained on treatment until the end of the reporting period [Target:

Not assigned; Reporting Frequency: Quarterly]

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should propose additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. Custom indicators should include process and outcome measures directly correlated with the logic model. Below are examples of additional process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated sections.

• Percentage of HIV negative clients tested who are referred to PrEP Services [Target >=90%; Reporting Frequency: Quarterly]

• Percentage of PrEP clients transferring out of PEPFAR facilities [ Target <=10%;

Reporting Frequency: Quarterly]

• Percentage of PrEP clients initiating PrEP services within 1 week of initial HIV negative test [Target >= 90%; Reporting Frequency: Quarterly]

• Percentage of missed appointments have results of tracking efforts: [Target >=90%;

Reporting Frequency: Quarterly]

• Percentage of PLHIV linked to same-day ART initiation or rapid initiation [Target >=90%; Reporting Frequency: Quarterly]

• Percentage of supportive environments for all clients seeking HIV/STI services in public facilities [Target >=90%; Reporting Frequency: Quarterly]

• Percentage of staff (by the following cadres) trained (new or refresher) in the following areas: Clinical management, medical officers (MOs), PrEP (MOs, Social worker), S&D (All cadre); Prevention and Testing services, Data Quality & Reporting: [Target >=90%;

Reporting Frequency: Annually]

• Percentage of sites reporting improved data quality for prevention, testing, treatment, and retention [Target: 95%; Reporting Frequency: Quarterly]

• Percentage of sites utilizing treatment data dashboard [Target: 95%; Reporting…