Foa_Content_of_CDC-RFA-GH-24-0102.pdf

Centers for Disease Control and Prevention

Center for Global Health

Enhance Population Access to Comprehensive HIV/AIDS Services to Achieve HIV/AIDS Epidemic Control in the Democratic Republic of the Congo (DRC), Specifically in Kinshasa

Province under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0102

02/19/2024

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-24-0102. 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:

Enhance Population Access to Comprehensive HIV/AIDS Services to Achieve HIV/AIDS Epidemic Control in the Democratic Republic of the Congo (DRC), Specifically in Kinshasa Province under the President's Emergency Plan for AIDS Relief (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.

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)

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0102

E. Assistance Listings Number:

93.067 F. Dates:

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

2. Due Date for Applications:

02/19/2024 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 supports accelerating a comprehensive HIV prevention, care, and treatment program to achieve HIV epidemic control in selected Health Zones (HZ) within the Kinshasa province of DRC. The comprehensive treatment program aims to provide evidence-based interventions, and innovative strategies to offer HIV testing, care, and prevention, especially among those unaware of their status, people living with HIV (PLHIV) not on treatment, and those requiring preventive services especially among priority populations (PP) and hard to reach populations through a person-centered approach. The recipient will provide direct support and technical assistance (TA) to the Ministry of Health (MOH) and Ministry of Social Affairs to accelerate the HIV service delivery cascade and strengthen the technical capacity of provincial and HZ level teams to analyze data, improve data quality, and utilize data for informed decision-making. The recipient is expected to engage community organizations to contribute by improving uptake of HIV services, linkage, and retention. The overall NOFO goal aligns with the PEPFAR 2030 strategic direction to eliminate the HIV/AIDS pandemic as a public health threat while sustainably strengthening the public health system within the selected HZ of the Kinshasa province. PEPFAR DRC is focused on equity for PP, sustainability, health system strengthening and using data or evidence-based science for programming per the new PEPFAR 5x3 strategic vision.

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 https://www.grants.gov/

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:

$4,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $4,000,000. 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 The estimated population of DRC is 98,370, 000 (National Institute of Statistics-INS,2020).

Kinshasa, the capital of DRC has a population estimated at 13,916,000 (INS,2020). The Demographic and Health Survey (DHS) for 2013-2014, estimated the National HIV prevalence in the adult population aged 15–49 years at 1.2%, and the latest SPECTRUM estimates indicate a prevalence of 0.7 % and an annual incidence of 0.21 in adults aged 15–49 years in 2020.The HIV prevalence is higher in urban cities (1.6%) versus the rural areas with (0.9%). According to the National AIDS Control Program annual report in 2022, the data shows that of all adults living with HIV (aged ≥15 years) who were tested for HIV and know their HIV status (83%),82% are on antiretroviral therapy(ART), yet the viral load suppression (VLS) is < 85% and the viral load coverage (VLC) is at only 58%.

Despite advances made by DRC to reach the UNAIDS 95-95-95 targets at the end of 2030, equity among affected populations (general population versus key populations [KP]) differs, particularly with access to HIV services. DRC must scale up equity efforts to achieve the targets and address inequalities.

Through this NOFO, the recipient will support the Government of DRC (GDRC) to ensure that person-centered direct service delivery to all PLHIV and those at risk of HIV acquisition is in line with national guidelines and PEPFAR strategic objectives to decrease new infections and reach epidemic control. The recipient will also support GDRC to provide targeted TA to build and maintain capacity. These efforts include strengthening existing systems to provide focused, prioritized, and data-driven program implementation and comprehensive HIV services.

This NOFO will support the following strategies in 6 HZ within the Kinshasa province:

• Strengthen national and provincial programmatic leadership.

• Enhance health equity and reduce disparities in access, use, uptake, and continuity of comprehensive HIV services for PP.

• Develop, validate, and evaluate public health programs to inform, improve, and target appropriate, innovative interventions for the prevention, care and treatment of HIV/AIDS, TB, and opportunistic infections (OI).

• Through innovative approaches, improve demand creation for HIV testing by healthcare workers (HCW) and linkage to treatment for all HIV-positive persons, including PP (e.g., adolescent girls and young women (AGYW), KP, PBFW, HIV exposed infants (HEI), and children and adolescents living with HIV (C/ALHIV)).

• Increase access to HIV self-testing, improve scale and fidelity of HIV testing, and ensure safe and ethical index testing practices (children and partners).

• Ensure person-centered and appropriate care for all PP and PLHIV to improve case finding and adherence to treatment.

• Implement a targeted testing approach that tests all people who present for care in the following clinics and sites:antenatal care, TB, STI, malnutrition (for children), harm reduction, and as clinically indicated.

• Implement innovative activities to improve case finding for hard-to-reach KP.

• Ensure Continuous Quality Improvement (CQI) at site level, including quality data.

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 intends to leverage achievements under the expiring NOFO, CDC-RFA-GH19-1934, and close identified gaps for better outcomes. During FY23, PEPFAR DRC, while working to address data quality challenges, will continue to spearhead the implementation of effective programs in an equitable manner, including focusing on underserved populations, especially KP, children, AGYW, and pregnant and breastfeeding women (PBFW) in 3 provinces of DRC. In these 3 provinces, close to 600 health facilities scattered in 57 HZ will be offered tailored services aiming at finding, linking, maintaining on treatment, and monitoring treatment through VLS. Working in Kinshasa within 6 HZ, the recipient(s) of this NOFO will then prioritize implementation of optimized targeted testing through other Provider- Initiated Testing and Counseling platforms, ethical and safe index testing, reasonable use of self-testing and other relevant facilities and communities testing modalities for improved case finding. In addition, the recipient(s) will continue to support the implementation of Multi-Monthly Dispensing (MMD) of ARV and the identification and proper management of Advanced HIV Disease (AHD) and TB.

Constructing on a data quality culture, the recipient(s) will work to ensure that a person’s needs, both prevention and treatment, are addressed along the continuum of the clinical cascade.

Focused attention is expected of the recipient(s) to attain the needs of ameliorating unsatisfactory VLC this far. Another area of attention includes the need to close the treatment gap for children 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 and adolescents through the acceleration of case finding efforts for child- bearing-aged women and children, through enhancing 2-month early infant diagnosis (EID) coverage. The Orphans and Vulnerable Children (OVC) platform has proven to be an excellent avenue for addressing some of the above challenges (including the EID coverage gap). PEPFAR DRC will continue to grow in uptake and use of pre-exposure prophylaxis (PrEP) among high-risk groups (e.g., AGYW, KPs, PBFW, and discordant couples). Clinical recipients strategically rely on CQI opportunities including findings from Community-led monitoring (CLM) partners and other relevant community stakeholders.

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:

Implement innovative HIV and TB case finding approaches for PP to increase PEPFAR 95-95-95 for the 1st 95 and 3rd 95 cascade

Strategy 2:

Implement comprehensive HIV and TB services (e.g., prevention, initiation, adherence, and retention) for PP to increase use of HIV and TB services

Strategy 3: Apply sustainable solutions to address barriers to HIV and TB continuity of treatment for PLHIV to increase access and use of HIV and TB services

Strategy 4: Build capacity of GDRC to facilitate sustainable transition of HIV and TB services

Strategy 5:

Strengthen national data quality systems to facilitate data-driven program planning and service delivery

Increased casefinding of

PP

Increased PLHIV initiated and maintained on treatment regimens

Increased coverage of TB preventive treatment (TPT) for PLHIV

Improved coverage of prophylaxis treatment for PLHIV

Increased capacity of HCW to provide AHD case management

Increased accessibility of HIV prevention services for PP

Increased enrollment of PP in the OVC program

Increased program management capacity of GDRC in HIV response through TA

Increased capacitation of program staff to collect, analyze, and use datafor decision-making with site-level facility staff

Increased use of data quality procedures by program staff

Increased continuity oftreatment for PLHIV

Increased VLCand VLS among PLHIV

Increased TPT completion for PLHIV

Reduced co-infections for PLHIV

Increased use of HIV prevention services by

PP

Increased competency of GDRC to manage HIV response

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

Reduced new HIV infections and transmission among PP

Reduced morbidity and mortality for

PLHIV

Improved quality of life for PLHIV

Sustained use of comprehensive HIV services for

PP

Increased sustainable ownership of HIV response by GDRC

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

i. Purpose The purpose of this NOFO is to continue providing HIV prevention and treatment comprehensive services for persons within PEPFAR-supported HZ in the Kinshasa province of

DRC. The program aims to facilitate access to quality HIV services to populations in need through an integrated health equity approach. The provision of services also aims to provide targeted TA to MOH staff for empowering ownership and further sustainable implementation of services towards epidemic control.

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 case finding of PP o Case finding includes, but is not limited to recency testing, index testing (e.g., family-based index testing), HIV self-testing, and other testing modalities

• Increased PLHIV initiated and maintained on treatment regimens o Treatment regimens include, but are not limited to adherence and maintenance of treatment, same-day initiation, MMD, differentiated service delivery (DSD), etc.

• Increased coverage of TPT for PLHIV

• Improved coverage of prophylaxis treatment for PLHIV o Prophylaxis treatment includes, but is not limited to CTX, fluconazole, etc.

• Increased capacity of HCW to provide AHD case management o Capacity includes, but is not limited to knowledge and skills for HCW, equipment, supplies, etc.

• Increased accessibility of HIV prevention services for PP o HIV prevention services include but are not limited to PrEP, condom distribution, Post- Exposure Prophylaxis (PEP), mental health services, cervical cancer screening (CCS), etc.

• Increased enrollment of PP in the OVC program

• Increased program management capacity of GDRC in HIV response through TA o GDRC includes, but is not limited to the MOH (e.g., HZ, TB Program, HIV Program, Health Provincial Division, National Public Health Institute), Social Affairs, etc.

• Increased capacitation of program staff to collect, analyze, and use data for decision-making with site-level facility staff

• Increased use of data quality procedures by program staff

Intermediate Outcomes:

• Increased continuity of treatment for PLHIV o Continuity of treatment includes, but is not limited to managing interruption in treatment(IIT) and return/re-engagement in care, disclosure of HIV status(e.g., adolescents and children), adherence, etc.

• Increased VLC and VLS among PLHIV

• Increased TPT completion for PLHIV

• Reduced co-infections for PLHIV o Co-infections include, but are not limited to TB, cryptococcus, toxoplasmosis, Hepatitis B, Hepatitis C, STIs, etc.

• Increased use of HIV prevention services by PP o HIV prevention services include but are not limited to PrEP, condom distribution, PEP, mental health services, CCS, etc.

• Increased competency of GDRC to manage HIV response

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

Long-Term Outcomes:

• Reduced new HIV infections and transmission among PP

• Sustained use of comprehensive HIV services for PP

• Increased use of high-quality data and evaluation findings 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: Implement innovative HIV and TB case finding approaches for PP to increase PEPFAR 95- 95-95 for the 1st and 3rd cascade

• Scale-up safe and ethical index testing at all sites and in the community adhering to safe and ethical standards including in children and adolescents (e.g. HEI, AGYW, etc.)

• Scale-up targeted testing modalities

• Expand HIV self-test availability

• Expand social network and community measures to reach special populations

• Expand existing strategies to improve case identification, linkage, and early retention for

PP within priority HZ and other sites with gaps in coverage

• Review, update, and implement HIV and TB screening tools

• Ensure distribution of self-testing kits to hard-to-reach contacts

• Scale up the HIV testing including EID sample collection in the OVC household

• Leverage community partners to find cases

• Expand maternal retesting

• Develop, in collaboration with public health stakeholders, clinical screening tools for

HIV

Strategy 2: Implement comprehensive HIV and TB services (e.g., prevention, initiation, adherence, and retention) for PP to increase use of HIV and TB services

• Strengthen clinical-community collaboration for continuity of treatment and monitoring for all PLHIV including PBFW, HEI, children living with HIV, etc.

• Implement innovative strategies to prevent interruptions in treatment (IIT) for all PLHIV including adolescents

• Implement innovative strategies to prevent IIT for all adolescents

• Targeted community HIVST for adolescents

• Increase demand for HIV services(e.g., HIV testing, condom distribution, PrEP, PEP, counseling, sexual and reproductive services, CCS, etc.)

• Implement activities in support of the Undetectable=Un-transmittable (U=U) campaign

• Ensure active monitoring and scale-up of VLC/VLS for infected OVC and their parents living with HIV

• Strengthen collaboration between healthcare facilities and community providers to accelerate the enrollment of infected/affected children and adolescents in the OVC program

• Prioritize referral and enrollment of challenging cases to the OVC program

• Ensure and optimize scale-up of the pediatric case management tool

• Scale-up and sustain VLC and VLS for all eligible patients on treatment

• Capacitate healthcare facilities (HCF) and HCW to deliver AHD management services through a phased approach

Strategy 3: Apply sustainable solutions to address barriers to HIV and TB continuity of treatment for PLHIV to increase access and use of HIV and TB services

• Capacitate HCW to deliver KP-appropriate and competent services to address stigma and discrimination (S&D) in HCF through a phased approach

• Strengthen referral system for GBV and IPV services and post-violence services for AGYW to address stigma associated with GBV and IPV

• Increase the availability and usage of HIVST kits for PP (e.g., AGYW, children over 2 years of age, KP, etc.) to address S&D

• Ensure PP-appropriate services at facilities to increase uptake and continuation of services

• Through routine quality assessments and tool use, capacitate HCF to implement and adhere to infection prevention control practices to address barriers to the use of HIV and TB clinical services

• Within a multi-month dispensing context, provide client-centered differentiated service delivery models for drug delivery

Strategy 4: Build capacity of GDRC to facilitate sustainable transition of HIV and TB services

• Provide routine training of trainers and cascade down at different levels of the health pyramid on the implementation of HIV and TB response activities

• Provide financial and program management capacity building to GDRC staff for national leadership and ownership in HIV and TB response activities

Strategy 5: Strengthen national data quality systems to facilitate data-driven program planning and service delivery

• Support the development, implementation, and continual assessment of national policy and data collection and visualization tools (e.g., electronic medical record (EMR) system, index testing, linkage, retention, viral load status, etc.) in clinical and key community sites

• Provide mentorship and supportive supervision on M&E activities to inform data-driven program planning, improve data quality, and enhance service delivery

• Collaborate with HZ and facility management teams to conduct CQI and Data Quality Assessment (DQA) practices to increase effective monitoring of quality data and use

• Train GDRC and relevant staff at different levels of the health pyramidon data collection, data analysis, and data use for decision-making

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-funded organizations (e.g., recipients) in neighboring HZs, especially 1) those with OVC activities to facilitate transfer and support, 2) laboratory partners, 3) MOH PNLS-funded, and 4) strategic information system strengthening partners.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with non-CDC-funded PEPFAR agencies and programs (i.e., USAID-funded partners, including the supply chain partner, the MOH through the National HIV/AIDS Control Program (PNLS), the Ministry of Social Affairs (OVC program), non-governmental organizations, local government agencies, and other non-CDC-funded Implementing Partners.

2. Population(s) of Focus The priority population(s) of focus for this NOFO include children and adolescents <20 years, PBFW, and KP as they pertain specifically to clinical service delivery, HZ officers, and clinical and community-based workers. Additional priority populations of focus include men who have sex with men, transgender people, sex workers, people who inject drugs, and people in prisons and other enclosed settings.

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 $4,000,000 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.

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 6% of funds should be allocated for monitoring activities and 3% 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:

• GEND_GBV: Number of people receiving post-gender based violence clinical care based on the minimum package [Target: 50; Reporting Frequency: Semi-Annual]

• 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: 2762; 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: 3008;

Reporting Frequency: Quarterly]

• TB_PREV: Proportion of ART patients who started on a standard course of TPT in the previous reporting period who completed therapy [Target: 100%; Reporting Frequency:

Semi-Annual]

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results [Target: 4190; Reporting Frequency: Quarterly] https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• HTS_RECENT: Number of newly diagnosed HIV-positive persons who received testing for recent infection with a documented result during the reporting period [Target: 2048;

Reporting Frequency: Quarterly]

• HTS_SELF: Number of individual HIVST kits distributed [Target: 6,745; Reporting Frequency: Quarterly]

• HTS_TST: Number of individuals who received HIV Testing Services and received their test results [Target: 68,490; Reporting Frequency: Quarterly]

• PMTCT_EID: Percentage of infants born to HIV-positive women who received a first virologic HIV test (sample collected) by 12 months of age [Target: 95%; Reporting Frequency: Quarterly]

• PMTCT_FO: Percentage of final outcomes among HIV exposed infants registered in a birth cohort [Target: 100%; Reporting Frequency: Annual]

• PMTCT_HEI_POS: Number of HIV-infected infants identified in the reporting period;whose diagnostic sample was collected by 12 months of age [Target: Not Assigned; Reporting Frequency: Quarterly]

• PMTCT_STAT: Percentage of pregnant women with known HIV status at antenatal care [Target: 100%; Reporting Frequency: Quarterly]

• TB_STAT: Percentage of new and relapse TB cases with documented HIV status [Target:100%; Reporting Frequency: Quarterly]

• PMTCT_ART: Percentage of HIV-positive pregnant women who received ART to reduce the risk of mother-to-child-transmission during pregnancy [Target: 100%;

Reporting Frequency: Quarterly]

• OVC_HIVSTAT: Percentage of orphans and vulnerable children(<18 years old) enrolled in the OVC Comprehensive program with HIV status reported to implementing partner [Target: 100%; Reporting Frequency: Semi-Annual]

• TB_ART: Proportion of HIV-positive new and relapsed TB cases on ART during TB treatment [Target: 95%; Reporting Frequency: Quarterly]

• TX_CURR: Number of adults and children currently receiving ART [Target:23,452;

Reporting Frequency: Quarterly]

• TX_ML: Number of ART patients (who were on ART at the beginning of the quarterly reporting period or initiated treatment during the reporting period)and then had no clinical contact since their last expected contact [Target: Not Determined; Reporting Frequency: Quarterly]

• TX_NEW: Number of adults and children newly enrolled on ART [Target:2085;

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 Determined; Reporting Frequency: Quarterly]

• TX_TB: Proportion of ART patients screened for TB in the semiannual reporting period who start TB treatment [Target: 100%; Reporting Frequency: Semi-Annual]

• TX_PVLS: Percentage of ART patients with a suppressed VL result (<1000 copies/ml) documented in the medical or laboratory records/laboratory information systems (LIS)within the past 12 months [Target: 95%; Reporting Frequency: Quarterly]

• EMR_SITE: Number of PEPFAR-supported facilities that have an electronic medical record system within the following service delivery areas: HIV Testing Services, Care & Treatment, Antenatal or Maternity Services, EID or Under Five Clinic, or TB/HIV Services [Target: Not Assigned; Reporting Frequency: Annual]

• OVC_SERV: Number of individuals served by PEPFAR OVC programs for children and families affected by HIV [Target: 7,054; Reporting Frequency: Semi-Annual]

Non-MER:Additional Performance Measures (Custom Indicators)

Applicants should propose additional custom performance measures to…