Revised Foa_Content_of_CDC-RFA-GH-24-0069 (1).pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Capacity of Central Asia and Eastern Europe Countries to Implement Sustainable and Effective HIV/AIDS Prevention, Care, and Treatment and Health Security Programs under

PEPFAR

CDC-RFA-GH-24-0069

03/04/2024

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-24-0069. 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 Capacity of Central Asia and Eastern Europe Countries to Implement Sustainable and Effective HIV/AIDS Prevention, Care, and Treatment and Health Security Programs 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.

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.

Amendment 1: Questions and Answers (Q&A) and Letter of Intent (LOI) Clarification

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

• There was no Q&A for this NOFO

• 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. There may be dates populated in some NOFOs in the LOI fields (1. Due Date for Letter of Intent (LOI) under Part I. Overview, and a. Letter of Intent Deadline under D. Application and Submission Information), but this is an error CDC is working to fix. These sections should be blank to reflect that LOIs are not requested or required.

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

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0069

E. Assistance Listings Number:

93.067,93.318 F. Dates:

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

12/20/2023

2. Due Date for Applications:

03/04/2024 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 aims to enhance Central Asia's capacity to provide high-quality HIV/AIDS prevention, treatment, laboratory, and strategic information (SI) programs. The goal is to achieve epidemic control by 2030, following international standards (e.g., UNAIDS, International Health Regulations), and adapted to the local context. Based on PEPFAR's 5x3 Strategic Framework (September 2022), the focus is on leveraging investments to build resilient health systems that can effectively respond to public health threats. Key areas of focus include:

• Establishing access to evidence-based HIV prevention services such as case-finding, client-centric referral, pre-exposure prophylaxis (PrEP), and Medication-Assisted Therapy (MAT) services;

• Improving client-centric HIV treatment continuity to achieve 95-95-95 and address related co-morbidities through enhanced patient management, monitoring, laboratory capacity, care, treatment, and patient satisfaction;

• Strengthening capacity for collecting, managing, and utilizing SI to inform program implementation and impact assessment;

• Enhancing the health system’s ability to strengthen public health security, preparedness, and response;

• Ensuring sustained, resilient public health programs at individual, facility, and organizational levels to achieve HIV/AIDS epidemic control; and

• Coordinating with key community and relevant stakeholders for evidence-based policy development, sustained program design, financing, and implementation.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The expected number of awards is 1-2.

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:

$3,200,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $3,200,000. The expected number of awards is 1-2. 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 This NOFO aims to promote and strengthen regional and country leadership and HIV/AIDS response implementation and essential public health functions, including laboratories, surveillance and information systems, emergency response capacity, and the public health workforce.

Kazakhstan (KZ) (population of 19.8 million) has a growing HIV epidemic and has registered 3,700 new HIV cases in 2022. The epidemic is concentrated among key populations (KP), including people who inject drugs (PWID) (HIV prevalence 7.2%; estimated number 79,900;

2020), men who have sex with men (MSM) (HIV prevalence 6.9%; estimated number 62,000;

2019), and commercial sex workers (CSW) (HIV prevalence 1.3%; estimated number 21,500;

2019). The recently approved HIV Roadmap focuses on aggressive PrEP expansion, a rapid test-based new HIV testing algorithm, and expanded availability and monitoring of tenofovir/lamivudine/dolutegravir (TLD) administration. Other priority populations include migrants and prisoners due to their increased vulnerability to engaging in high-risk behaviors and lower access to HIV prevention and care services. Due to significant change in people living with HIV (PLHIV) estimates from 35,000 (2021) to 38,600 (2022), HIV awareness among those individuals living with HIV (i.e., the first 95 UNAIDS target) dropped substantially in all regions. As of December 2022, the national cascade is 79-84-87.

The Kyrgyz Republic (KR) (population of 6.8 million) faces economic and political challenges.

KR is a transit and destination country for global heroin trafficking. As a result, injection drug use is widely prevalent, contributing to HIV and Hepatitis C transmission. The number of new HIV infections has remained steady or slightly decreased over the decade in accordance with population growth (less than 1,000 in 2022), and the estimated number of deaths is more than 200 in 2022. There are 11,295 PLHIV based on recent SPECTRUM estimates. The HIV epidemic is concentrated among KP, including PWID and MSM. A recent population-based biobehavioral study (BBS) estimated HIV prevalence among PWID to be 13.3-25.9% and HIV prevalence among MSM to be 5.3-16.2%. Hepatitis C virus (HCV) is a key co-infection, with an estimated 67% of PWID previously infected and 39% currently infected. The national cascade is 83-70-90.

The Republic of Tajikistan (TJ) (population of 9.8 million) faces health and economic challenges. Its regional position exposes TJ to communicable diseases, especially in border areas. Gaps in the current surveillance system make the issue of infectious diseases challenging.

The healthcare system faces a shortage of healthcare workers, inadequate infrastructure, and limited access to healthcare services in rural areas. There were an estimated 15,000 PLHIV in 2022. Since 2010, new HIV infections have increased by 23% while AIDS-related deaths have decreased by 5%. The majority of PLHIV and new infections are among KPs, including PWID, MSM, and FSW (female sex workers), and select priority groups (e.g., people who use non-injecting drugs (PUD), migrants, and prisoners). A recent BBS (2022) estimated HIV prevalence among PWID to be 4.7-19.9% and HIV prevalence among FSW and MSM to be 1.5-3.9% and

2.8-5.0% accordingly across sentinel sites. HCV is a key co-infection with an estimated up to 40% of PWID previously infected and up to 24% currently infected. The national cascade is 70- 84-94.

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.

Non-PEPFAR (Global Health Security) Funding:

This program is authorized under Section 307 of the Public Health Service Act [42 USC 242l] and Section 301(a) [42 USC 241(a)] of the Public Health Service Act.

c. Healthy People 2030 This project supports the following Healthy People 2030 topic areas:

• Global Health

• Public Health Infrastructure

• Health Care Access and Quality

• Infectious Disease

• Emergency Preparedness

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.

Activities funded through this cooperative agreement must align with the following United States Government (USG) and HHS/CDC strategies and policies:

• CDC's strategy for improving global health security (GHS), based on three concepts embedded in the agency's mission to protect public health worldwide: 1) Prevent, 2) Detect, 3) Respond: https://www.cdc.gov/globalhealth/security/index.htm

• The Department of Health and Human Services' (HHS) Global Health Strategy:

https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html

• International Health Regulations (2005) (IHR) and supporting policies and frameworks: https://www.who.int/topics/international_health_regulations/en/

e. Relevant Work This follow-on NOFO builds on current work under CDC-RFA-GH19-1917. The goal of the previous award was to provide technical assistance (TA) for building capacity in the Central Asia Region so that HIV prevention, care, and treatment services for people at risk for and living with HIV/AIDS were provided according to the national standards and followed international standards. Those services covered the continuum of care for PLHIV, with focus on KP, and included laboratory, care, treatment, and SI to reach the UNAIDS 95-95-95 targets to achieve 95% of PLHIV tested and diagnosed, 95% of those diagnosed placed on anti-retroviral therapy (ART), and 95% of those on ART virally suppressed.

Since 2011, work has focused on supporting HIV and other public health programs in Central Asia, in partnership with the Ministry of Health (MOH), national and local AIDS centers, national and local narcology centers, and primary health care facilities in KZ, KR, and TJ.

Implementing partner efforts have resulted in substantial strengthening of health systems, including surveillance, and monitoring and evaluation (M&E) systems; and introduced innovations in HIV programming and data systems that have been successfully adopted and scaled up in KZ, KR, and TJ. The previous NOFO provided support to the MOH in KZ, KR, and TJ with the aim of enhancing HIV prevention, case finding, and treatment for PLHIV and KP, supporting national SI activities, and engaging key in-country stakeholders.

The lessons learned from the previous NOFO include but are not limited to the following:

• Innovative HIV case-finding including index testing and HIV self-testing using a ‘status-neutral’ approach to ensure linkage to appropriate prevention and treatment services;

• Assisted MOH to develop, scale up, monitor, and sustain effective models of HIV prevention, rapid initiation and continuity of ART and treatment adherence support;

• Lessons for the implementation and monitoring of effective PrEP delivery to those at increased risk for HIV;

• Practices to ensure active follow-up of PLHIV to prevent treatment interruption;

• Stronger effort is required to identify best practices, implement, and evaluate them via the current Cooperative Agreement (CoAg), and then rapidly apply them nationally;

• The previous NOFO has been successful in overcoming and addressing chronic

HIV/AIDS Antiretroviral (ARV) deficits in the Central Asia region;

• The previous NOFO established rigorous routine monitoring of the program through analysis of the Electronic HIV Case-based Management system as well as site visits to poor performing regions throughout the country with special focus on the PEPFAR sites;

• Strong emphasis on quality data collection, analysis, and utilization is essential for program monitoring, design, and implementation;

• The CoAg was able to improve on the strategic use of information that led to impactful and quality programming. Such efforts need to be enhanced and expanded.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1: Plan and implement evidence-based effective HIV prevention, treatment, and harm-reduction services across all health facilities in compliance with global and national standards

Strategy 2:

Coordinate and support comprehensive capacity-building strategies to improve client-centered HIV care and treatment and associated co-morbidities for at-risk populations

Strategy 3:

Enhance the health system’s public health security, preparedness, and response

Strategy 4:

Support SI and surveillance systems to collect, manage, monitor, and evaluate program implementation, achievements, and impact

Increased stakeholder knowledge of evidence-based policies and strategies for compliance with global and national standards

Increased coverage of harm-reduction services among at-risk populations

Improved client-centered, comprehensive HIV service approaches

Increased coverage of standardized capacity-building strategies for public sector health institutions and administrative levels

Increased knowledge of the epidemiological workforce to detect and respond to public health security concerns

Increased knowledge of laboratory staff to detect and report outbreaks of emerging and re-emerging pathogens

Increased availability of high-quality data through electronic surveillance systems to monitor and evaluate program implementation

Increased linkage to client-centered, comprehensive HIV services

Increased adherence to treatment for

PLHIV

Increased capacity of the epidemiological workforce to effectively monitor, report, and respond to ongoing HIV transmission

Increased ART initiation, coverage, and adherence for target populations and geographies

Increased viral load (VL) testing coverage among PLHIV

Increased capacity of laboratory staff to detect and report outbreaks of emerging and re-emerging pathogens

Increased quality of laboratory diagnostic testing for all laboratories in the health system

Increased timely monitoring and reporting of high-quality data for data-driven decision-making

Increased capacity within the public health system to respond to the HIV epidemic and other public health concerns

Increased viral load suppression (VLS) rates among PLHIV

Improved HIV program management at all levels

Reduced HIV incidence among all populations

Reduced HIV-related morbidities and mortalities among all populations

Improved public health security and National Government response capability at regional and national levels

Increased use of high-quality data and evaluation findings by key stakeholders to inform national policy and programs

i. Purpose

The purpose of this NOFO is to strengthen Central Asia’s health systems to reduce new HIV infections and AIDS deaths through the implementation of innovative, evidence-based prevention, testing, care, and treatment services to at-risk populations. Additionally, this NOFO will strengthen SI systems to achieve HIV epidemic control as well as enhance the ability for the health systems to strengthen public health security, preparedness, and response to emerging and re-emerging diseases.

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 stakeholder knowledge of evidence-based policies and strategies for compliance with global and national standards

• Increased coverage of harm-reduction services among at-risk populations

• Improved client-centered, comprehensive HIV service approaches

• Increased coverage of standardized capacity-building strategies for public sector health institutions and administrative levels

• Increased knowledge of the epidemiological workforce to detect and respond to public health security concerns

• Increased knowledge of laboratory staff to detect and report outbreaks of emerging and re-emerging pathogens

• Increased availability of high-quality data through electronic surveillance systems to monitor and evaluate program implementation

Intermediate Outcomes:

• Increased linkage to client-centered, comprehensive HIV services

• Increased adherence to treatment for PLHIV

• Improved capacity of the epidemiological workforce to effectively monitor, report, and respond to ongoing HIV transmission

• Increased ART initiation, coverage, and adherence for target populations and geographies

• Increased VL testing coverage among PLHIV

• Increased capacity of laboratory staff to detect and report outbreaks of emerging and re-emerging pathogens

• Increased quality of laboratory diagnostic testing for all laboratories in the health system

• Increased timely monitoring and reporting of high-quality data for data-driven decision-making

Long-Term Outcomes:

• Increased capacity within the public health system to respond to the HIV epidemic and other public health concerns

• Increased VLS rates among PLHIV

• Improved HIV program management at all levels

• Increased use of high-quality data and evaluation findings by key stakeholders to inform national policy and programs

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: Plan and implement evidence-based effective HIV prevention, treatment, and harm-reduction services across all health facilities in compliance with global and national standards

• Support the revision of policies and strategies in accordance with updates in international recommendations and standards in a timely manner

• Organize regular technical meetings with CDC and other stakeholders that inform activities direction

• Expand new and innovative HIV case-finding approaches to improve and optimize case finding:

o Develop and implement appropriate and innovative approaches for the distribution of HIV self-testing and linkages to services o Develop Standard Operating Procedures (standard operating procedures provide training, and implement HIV self-testing) o Develop and implement an optimal new testing algorithm based on international standards and recommendations o Expand ethical social network HIV testing approaches as a status-neutral HIV case-finding strategy o Train laboratory and community workers on optimal testing protocols o Develop and implement external and internal quality assurance programs for HIV testing in collaboration with the World Health Organization (WHO) o Train laboratory and community staff on internal and external quality assurance

(EQA) program o Support programs to link HIV-negative clients to key prevention services (e.g., PrEP, condoms, harm-reduction) o Support programs to link HIV-positives to HIV treatment services within 7 days after HIV diagnosis, with a focus on ‘same-day initiation’

• Scale up high-quality PrEP program nationwide:

o Train medical staff on PrEP based on previously developed PrEP guidelines o Develop and implement e-PrEP database for people on PrEP to monitor PrEP implementation in the country and train medical staff on e-PrEP o Implement and evaluate multi-month PrEP dispensation (MMD) o Conduct PrEP demand generation activities o Support Undetectable=Untransmittable (U=U) campaign nationwide

• Support uptake of MAT among PWID o Train medical staff on multiple MAT treatment options o Train medical staff on PWID counseling and referrals to MAT o Support, adjust, and improve Electronic Methadone Register o Support access for PWID to mental health services

Strategy 2: Coordinate and support comprehensive capacity-building strategies to improve client-centered HIV care and treatment and associated co-morbidities for at-risk populations

• Update care and treatment clinical protocol according to the latest WHO recommendations

• Train health care workers (HCWs) including primary HCWs on the new clinical protocol and HIV case management

• Implement ‘Test and Treat’ to ensure rapid initiation of ART for diagnosed PLHIV

• Work on successful transition to optimal ART regimens (e.g., TLD) through training and mentoring of medical staff

• Re-engage PLHIV, including KP, who are currently interrupted in treatment

• Develop and provide innovative and effective ART adherence strategies in PLHIV, focusing on at-risk populations

• Support facility- and community-based retention in medical care, treatment, and prevention services for PLHIV with a focus on most-at-risk and marginalized populations

• Support EQA and internal quality control (IQC) activities for VL monitoring

• Strengthen adherence counseling, treatment and VL literacy to achieve viral suppression

• Support and scale up site-level management and continuous quality improvement support activities to improve quality of care and treatment services

• Implement differentiated approach - MMD of ARVs – 3-6 months and more for stable patients

• Strengthen systems for the successful referral of PLHIV to other essential support services (e.g., behavioral and mental health services, substance-use treatment services through institutionalization of the above-mentioned services, screening and treatment of related co-morbidities)

• Provide support to optimize the quality of life for HIV-infected clients throughout the continuum of care by means of VL clinical stage monitoring, prevention, treatment, and management of opportunistic infections and co-morbidities, including introduction of viral hepatitis, sexually transmitted infections (STIs), and tuberculosis (TB)

• Train primary HCW in clinical care and management at the primary health care level

• Develop care and treatment programs to focus on the identification and clinical management of advanced HIV disease

• Train medical staff in the management of patients with advanced HIV disease

• Develop guidelines on quality assurance of the polymerase chain reaction HIV testing

• Train and mentor laboratory staff to perform appropriate clinical monitoring assays

• Address ARV drug resistance issues by performing a primary resistance test right after the confirmed HIV diagnosis

• Develop guidelines on quality assurance of HIV and co-morbidity testing

• Conduct regular monitoring visits to sites with poor performance

Strategy 3:Enhance the health system’s public health security, preparedness, and response

• Conduct trainings on new assays for staff of national and facility level laboratories

• Develop, implement, and monitor national laboratory plans

• Organize a training/workshop and quality assurance program including EQA and IQC for laboratory staff

• Support development of national laboratory plan for strategic planning and implementation of efficient specimen transport, laboratory diagnostics, and return of results

• Strengthen implementation of national event- and indicator-based surveillance systems including use of electronic reporting systems for communicable disease surveillance

• Develop and implement surveillance monitoring plans including weekly and monthly monitoring of timeliness and completeness of reporting, and quality of data, assessed through periodic data quality assessments (DQA)

• Support national and sub-national capacity-building for public health staff with disease surveillance and response responsibilities

Strategy 4: Support SI and surveillance systems to collect, manage, monitor, and evaluate program implementation, achievements, and impact

• Continue digitalization of surveillance systems

• Develop guidelines on Electronic HIV Case Management System (web-EHCMS) with analytical algorithm of HIV and other relevant public health data

• Support, adapt, and improve high-quality Electronic Methadone Register (E-MAT-R), as well as implement additional quality improvement (QI) and quality monitoring strategies for MAT

• Coordinate E-PrEP expansion

• Train medical and surveillance staff on data use and analysis (e.g., dashboards, triangulation, and other business intelligence platforms and tools)

• Provide support to the national and sub-national public sector and other transition recipients to generate and report quality data for Monitoring, Evaluation, and Reporting (MER) and custom indicators related to data for program improvement and decision-making

• Design and implement small scale projects in applied epidemiology, communications, performance monitoring, etc. to strengthen SI systems (e.g., surveillance data reports, DQA, QI projects)

• Conduct regular site-level mentorship and supervision to ensure accurate and complete data collection, management, reporting, and analysis

• Collaborate with international stakeholders to conduct routine M&E, Site Improvement Monitoring System (SIMS), DQA activities from an above-site perspective

• Continuously update and improve web-EHCMS for data monitoring and informed decision-making

• Develop strategic plans that outline the surveys and surveillance technical needs and priorities

• Work closely with the local governments and implementing partners to support evidence-based surveys and surveillance, such as case-based surveillance and bio-behavioral surveillance among high-risk populations

• Conduct routine surveillance, modeling, and estimation efforts to determine disease burden (e.g., prevalence, recency, co-morbidities, and program progress)

• Collaborate with local and international stakeholders to conduct surveys and surveillance, such as a comprehensive public health case-based surveillance system

• Support implementation of treatment resistance monitoring and surveillance surveys and systems

• Develop and maintain a surveillance system that measures HIV drug resistance among untreated patients, patients with prior treatment history, including women involved in perinatal transmission prevention programs

• Develop standardized protocols for sampling, data collection, laboratory handling, data management and analysis, quality control and ethical issues

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(s) will be expected to collaborate with other CDC-supported recipients, including Central Asian agencies and institutions at the national and sub-national levels as well as civil society and other non-governmental organizations (NGOs), and international recipients, working in HIV program coordination, TA provision, training, mentorship, and capacity building activities. This collaboration will focus on program implementation, coordination, technical support, and consultation, and is intended to ensure synergy and efficient services toward achieving project outcomes. This is also consistent with the mandate of the MOHs - to provide leadership, coordination, and oversight for all public health efforts in the respective countries in the region.

The recipient is required to work with other CDC implementing partners, including non-governmental organizations, universities, the Ministry of Health and other host governmental bodies and multi-lateral organizations that receive CDC funds. The recipient should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with other non-CDC U.S. Government (USG)-funded recipients (both PEPFAR and non-PEPFAR recipients), other bilateral and multilateral organizations, host government organizations, NGOs, civil society, and the private sector in planning, coordination, guideline development, capacity building, etc. All collaborations are intended to foster harmonization and complementarity of effort. This is also consistent with the mandate of the MOHs to provide leadership, coordination, and oversight for all public health efforts in the respective countries in Central Asia.

2. Population(s) of Focus The populations of focus for this NOFO include PLHIV, their sexual contacts and biological children, those infected with TB, HIV, STIs, and viral hepatitis, KP, persons seeking testing, care and treatment services at public and private health facilities, HCWs, and laboratorians. Focus will be given to those populations and geographies that are at increased risk of acquiring or transmitting HIV and related co-morbidities.

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…