NOFO for CDC-RFA-GH21-2178.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Public Health Responses and Accelerating HIV/AIDS Program for the Sustainable Provision of Comprehensive HIV/AIDS Services in Tigray Regional State of the Federal

Democratic Republic of Ethiopia under PEPFAR

CDC-RFA-GH21-2178

04/22/2021

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- GH21-2178. 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 Public Health Responses and Accelerating HIV/AIDS Program for the Sustainable Provision of Comprehensive HIV/AIDS Services in Tigray Regional State of the Federal Democratic Republic of Ethiopia 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 this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

Any applicant who downloaded the application package prior to March 24, 2021 (3/24/2021) must restart their application package due to a mandatory update to the HHS Checklist in the required application package forms in Grants.gov. Restarting the application process is required because the HHS Checklist will be removed from the application package on March 24, 2021.

NOTE: Once the applicant logs into Workspace, there will be a warning informing them that the application forms have changed for the NOFO they are applying for.

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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

Applicants should also note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO. Applicants do not need to submit an LOI.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH21-2178

E. Assistance Listings Number:

93.067,93.318 F. Dates:

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

03/23/2021

2. Due Date for Applications:

04/22/2021 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 intends to re-establish the support to Tigray Regional Health Bureau (TRHB) in the implementation of comprehensive HIV services in the Tigray Region to attain the UNAIDS 95- 95-95 goals. Tigray region accounts for 56,863 (8%) of the people living with HIV (PLHIV) population and 42,110 people on antiretroviral therapy (ART) in Ethiopia. With this NOFO, the TRHB will further strengthen its program management, technical, and monitoring capacity at all levels of the health system. The program will focus on geographies and populations highly affected by the HIV/AIDS pandemic to have greater impact and operational efficiency. Building on current achievements, the TRHB will focus on priority activities that have a significant impact on epidemic control of HIV/AIDS such as targeted HIV testing services (HTS), linkage to and initiation of ART, ensuring retention in treatment, and ensuring HIV viral load (VL) suppression.

a. Eligible Applicants:

Single

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

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

e. Average One Year Award Amount:

$ 5,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $5,000,000. The expected number of awards is 1. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

g. Estimated Award Date:

September 30, 2021

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 Ethiopia has a mixed HIV epidemic with a projected national prevalence of 1.1%, with Tigray’s adult HIV prevalence above average at 1.43%. The Ethiopian Population HIV Impact Assessment (EPHIA) study showed that the HIV prevalence among urban residents in Tigray Region was 2.7%; thus, urban residents should be prioritized with HIV prevention and treatment services. In 2019, 56,863 PLHIV (9% of the national burden) lived in the Region. The region had received direct site level support from CDC/PEPFAR from 2013 to 2018, during which time significant progress was made in scaling-up comprehensive HIV service provisions. The direct site level support was transitioned to a technical assistance (TA)-only model under the Federal HIV/AIDS Prevention and Control Office (FHAPCO) in 2019. During this time, the regional performance in HIV program measures, most notably implementation of new initiatives and VL suppression, lagged from the rest of Ethiopia. The regional VL coverage and suppression rate as of FY 2020 was very low (47% and 83%) as opposed to the commendable national performance (76% and 93%, respectively). The VL results are a result of poor-quality HIV treatment services, which are measured by slow progression in optimizing adult and pediatric ART regimens, and slow adoption of national practices to improve treatment linkage and retention. With the largest treatment cohort among PEPFAR-transitioned regions, poor performance in Tigray risks HIV epidemic control in Ethiopia nationally. Resuming direct site level services support is necessary to avoid further loss of HIV program gains previously achieved, and to ensure the provision of quality HIV services. To achieve the UNAIDS 95-95-95 targets by 2030, this NOFO will support TRHB to improve performance gaps and enhance the provision of quality HIV prevention, treatment, care and support services. PEPFAR support will prioritize locations with the highest unmet need and disease burden. While focusing on ensuring retention and VL suppression, TRHB will maximize its effort to identify gaps through a systematic assessment and implementation of effective measures at different levels of the health system structure. To maximize HIV case detection, a targeted testing strategy will be employed focusing on high yield HIV testing modalities including testing of key populations/priority populations (KP/PP), index case testing for sex partners and eligible biological children of index cases, and provider-initiated HIV testing (PITC). TRHB will further strengthen implementation of differentiated service delivery models to improve client-centered services, focusing on expansion of 3 and 6-multi-month ART dispensation (MMD).

TRHB will support the implementation of programs contributing to epidemic control including HTS, Pre-exposure prophylaxis (PrEP), ART, care and support, prevention of mother to child transmission (PMTCT), TB/HIV services, TB preventive treatment (TPT), HIV services for KP, laboratory services, gender-based violence (GBV) prevention and care, quality improvement (QI), and health system strengthening. Implementation of these programs will be geared towards PEPFAR goals to attain epidemic control through reducing new infections, restoring quality of life, and reducing morbidity and mortality. Strengthening of surveillance programs and monitoring and evaluation (M&E) system for evidence-based public health decisions in the region at both facility and population levels will further improve TRHB capacity to understand the epidemic and continually inform the program.

b. Statutory Authorities PEPFAR Funding:

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 Funding:

This program is also authorized under Public Health Service Act, Sections 301(a) and 307 as amended [42 U.S.C. §§ 241 and 242l].

c. Healthy People 2030 N/A

d. Other National Public Health Priorities and Strategies Under the leadership of the Office of the U.S. Global AIDS Coordinator (OGAC), as part of PEPFAR, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works with host countries 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 and partnership framework in a manner consistent with the purposes of this NOFO.

HHS/CDC focuses primarily on two or three major program areas in each country. Goals and priorities include the following:

Achieving primary prevention of HIV infection through activities such as expanding confidential counseling and testing programs linked with evidence-based behavioral change and building programs to reduce mother-to-child transmission;

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 partners and the integration of activities that promote Global Health Initiative principles. As such, recipients may be requested to participate in the following programmatic activities:

Implement a woman- and girl-centered approach;

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;

Build sustainability through investments in health systems;

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 total number of new infections falls below the total number of deaths from all causes among HIV-infected individuals (the classic R0 to Ri approach to infectious diseases), with both declining. 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 people living with HIV (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.

Effective December 1, 2018 and continuing throughout the five-year project period established under this NOFO, 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 key populations. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response. 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, remaining gaps, and informed 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 indigenous 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 policy and financial contributions by partner governments in the HIV/AIDS response.

Support activities, interventions, and programs 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.

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.

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: http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

e. Relevant Work The TRHB is the local governing body responsible for leading all health care activities, including the provision of comprehensive HIV services at health facilities, in the Tigray Region.

Until 2018, all PEPFAR-supported HIV prevention, care, and treatment site-level activities in the region were implemented by international implementing partners (IPs) and direct support to the RHB. In 2019, support was transitioned to FHAPCO and to Federal Ministry of Health (FMOH) in 2020. TRHB has built capacity through closely working with international IPs over the past 15 years, which has strengthened the ability to monitor all site-level HIV/AIDS programs. The TRHB, through PEPFAR support, has improved its capacity in managing, coordinating, and monitoring the overall HIV/AIDS activities in the region right after the transition of all support from international IPS which played a critical role in reversing the epidemic. From 2013 to 2018, TRHB received direct funding from PEPFAR/CDC and fully implemented site-level comprehensive HIV/AIDS program with the aim of strengthening local ownership for the sustainable provision of these services. This NOFO is a follow-on to CDC-RFA-GH18-1810 and will support the TRHB to continue work on the major gaps of HIV/AIDS program towards achieving UNAIDS 95-95-95 targets.

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:

Strengthen the delivery of quality

Improved access to quality comprehensive treatment services for

Increased HIV case detection and linkage to ART

Reduced incidence of HIV infection http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf comprehensive treatment services for HIV-infected adults, TB patients, and children including strengthening ART optimization, treatment retention, TPT/3HP scale-up and core HIV laboratory capacity to provide quality HIV care and treatment services

STRATEGY 2: Provide high impact HIV prevention services including targeted HTS/high yield testing modalities and linkages, PrEP for high risk populations in priority sub national units (SNUs), services for adult, pediatric, and KP/PP as well as support to GBV survivors

STRATEGY 3:

Implement data-driven activities at Health Facilities (e.g., facility as well as Community-led monitoring efforts, data and service QI) and strengthen M&E capacity and data use at all levels of health systems within the region including but not limited to case-based surveillance related activities

STRATEGY 4: Build the capacity of health care workers (HCWs) to

HIV and TB patients

Increased HIV case finding, testing, and linkage to HIV services for all clients including KP, PP, and GBV survivors

Increased coverage of PrEP services among high risk populations

Increased service uptake of prevention, screening and management of TB and other opportunistic infections (OIs)

Increased PMTCT and early infant diagnosis (EID) service uptake

Improved access to quality HIV and TB/TPT/3HP scale-up services

Improved access to quality assured core HIV laboratory services

Improved quality of surveillance, HIV, and TB program data

Improved institutionalization of QI activities

Improved competency of HCWs

Improved HIV treatment adherence

Improved retention in care and treatment services

Improved quality of HIV/TB care and treatment services

Improved quality of HIV and TB prevention services, Improved utilization of HIV and TB program data for decision making

Expanded workforce capacity

Improved HIV and TB treatment outcomes

Reduced mortality and morbidity among patients receiving ART provide quality HIV and TB data and services

i. Purpose The purpose of this NOFO is to ensure continuity of quality comprehensive HIV/AIDS prevention, care and treatment services provision for controlling HIV epidemic activities in Tigray region. Through this NOFO, the program is expected to improve access to integrated HIV/AIDS prevention, care and treatment services, increase ART coverage, decrease new HIV infections, enhance health system capacity to sustain quality HIV program intervention and improve efficient use of resources with the goal of reduction in HIV related morbidity and mortality and ultimately reaching an AIDS free generation.

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

Short-Term Outcomes:

Improved access to quality comprehensive treatment services for HIV and TB patients o Comprehensive treatment services should include access to psychological and mental health services and engagement of clients in adherence counseling

Increased HIV case finding, testing, and linkage to HIV services for all clients including KP, PP, and GBV survivors

Increased coverage of PrEP services among high risk populations Increased service uptake of prevention, screening and management of TB and other opportunistic infections (OIs) Increased PMTCT and early infant diagnosis (EID) service uptake Improved access to quality HIV and TB/TPT/3HP scale-up services Improved access to quality assured core HIV laboratory services Improved quality of surveillance, HIV, and TB program data Improved institutionalization of QI activities Improved competency of HCWs

Intermediate Outcomes:

Increase HIV case detection and linkage to ART Improved HIV treatment adherence Improved retention in care and treatment services Increased HIV case detection and linkage to ART Improved quality of HIV/TB care and treatment services Improved quality of HIV and TB prevention services Improved utilization of data HIV and TB programs for decision making o Data utilization should include use in planning, monitoring, and evaluation of HIV and TB program.

Expanded workforce capacity

Long-Term Outcomes:

Improved HIV and TB treatment outcomes

iii. Strategies and Activities Activities for year 1 are listed below. All activities, however, will be aligned with PEFPAR’s FY21 Country Operational Plan (COP21) direction for Ethiopia, including geographic focus of PEPFAR funded activities to achieve program targets for epidemic control of HIV/AIDS.

Activities may be modified based on subsequent COP approvals. Applicant may propose additional related project period activities other than those identified in the NOFO.

STRATEGY 1: Strengthen the delivery of quality comprehensive treatment services for HIV-infected adults, TB patients, and children including strengthening ART optimization, treatment retention, TPT/3HP scale-up and core HIV laboratory capacity to provide quality HIV care and treatment services

Adult, pediatric treatment, care and support, TB/HIV patients, PMTCT

Adult ART o Strengthen the linkage and inter/intra referral between health facilities and community-based organizations through catchment area meetings (CAMs), updating and utilizing service directories, utilizing and tracking referral forms o Ensure early assessment and prompt initiation on ART for newly diagnosed patients o Improve routine monitoring and adherence to care and treatment to maximize VL suppression, clinical staging, CD4 as per the national guideline o Provide site-level support through mentoring at the ART clinics in PEPFAR supported facilities in the region to improve service quality and provide onsite updates for providers o Provide oversight to the implementation of the case management program at site level o Strengthen the CAMs o Provide comprehensive regular mentoring and supportive supervision to ART sites through physical and virtual communities of practice support o Conduct regular program review for all program areas o Conduct site level forecasting and timely requesting for ART commodities o Provide all program area related job aids, reference materials, guidelines and other tools to ART sites o Implement differentiated models of service delivery based on national recommendations, with a focus on multi-month ART dispensation

Care and Support o Provide a package of Positive Health, Dignity and Prevention services to all

PLHIV as a standard of care at every point of care o Strengthen proper screening, assessment and management of OIs for all PLHIV at each patient encounter and provide co-trimoxazole preventive therapy (CPT) to the eligible ones o Provide nutritional assessment and counseling services (NACS) as a routine service to all PLHIV. Nutritional support (therapeutic food) should be provided to severely malnourished PLHIV in high priority SNUs or towns either by availing the commodity at the site or through referral and linkage with health facilities providing the service o Strengthen the integration of mental health services into chronic HIV/AIDS care program through training of lay-persons and clinicians or through referral and linkage to mental health services in high priority towns or SNUs

Pediatric Care and Treatment o Conduct targeted HIV testing for children of all ages via PITC clinics, pediatric inpatient services, TB clinics and for the orphans and vulnerable children (OVC) population o Strengthen family-focused HTC, care and treatment, and linkages to other services including testing of pregnant women in the antenatal care (ANC), labor and delivery and Post-natal care o Implement psychosocial care and support for children and adolescents addressing their psychological and spiritual needs o Integrate case managers into pediatric ART units to ensure retention, tracking, and referral for support services to available community-based organizations o Liaise with community-level partners to support uptake and adherence of HIV-exposed infant (HEIs) and pediatric patients and link to OVC programs for identification of HIV-exposed and infected children o Coordinate with the relevant partner to ensure rollout, implementation, and monitoring of pediatric preventive care package including utilization of CPT, TB screening, malaria prevention and treatment (including insecticide treated bed nets), prevention and treatment of diarrhea, linkages to immunization programs, and isoniazid preventative therapy (IPT) for HIV-positive children, and promote healthy hygiene & safe water interventions

TB/HIV

o Improve new HIV identification (1st 95) through maximizing routine testing among TB patients, TB household contact investigation using TB case as an index, testing of presumptive TB cases and intensified TB case finding at health facilities o Improve Universal ART coverage for HIV-positive TB patients (2nd 95) by improving ART provision to TB patients with 100% coverage o Improve TB/HIV co-management and treatment outcome (3rd 95) through provision of quality TB screening, increase access to optimal utilization of GeneXpert to diagnose TB among symptomatic HIV patients o Improve IPT coverage and improve monitoring of TPT, TB, and ART medication o Strengthen implementation of basic TB infection control interventions at all ART sites

PMTCT

o Improve IPT coverage and monitoring of ART provision among HIV positive TB patients o Strengthen implementation of basic TB infection control interventions at all ART sites o Increase access to EID diagnostic services and facilitate efficient use of Point of

Care (POC) testing in PMTCT sites which have Gene-Xpert machines o Improve ART coverage for HIV-infected women during pregnancy, delivery, and breast feeding and provide antiretroviral (ARV) prophylaxis to HEIs o Ensure provision of EID and services to HEIs including linkages and referrals of children living with HIV to care and treatment o Improve routine VL access, monitoring, and adherence to care and treatment to maximize VL suppression and reduce MTCT of HIV o Strengthen utilization of longitudinal PMTCT register to monitor and improve retention of mother baby pairs enrolled in care and treatment services until the final HIV status

Laboratory Services o Adopt existing national policies related with core HIV tests to implement regional level laboratory related policies, strategic plan, guidelines, and standards and organize regular laboratory program review meetings o Strengthen regional external quality assurance (EQA) program (on site supervision, proficiency testing (PT), and blinded rechecking) in Tigray Region and cover all high load and priority PEPFAR facilities o Implement process improvement informed by EQA performance. Procure equipment and supplies required for expanding EQA in scale up facilities. The regional laboratory, and selected hospitals designated as EQA centers, will prepare and distribute dried tube specimens and other panels and establish a system to maintain the quality of HIV rapid testing across different test points in health facilities following the QA cycle. The lab will also do quality check for each new batch of rapid test kits o Supporting laboratories enrolled in WHO/AFRO stepwise laboratory accreditation program in prioritized SNUs o Provide core HIV tests like infant virologic testing, VL, and TB diagnostics and send infant virologic and VL testing to the national data base system to be used for program evaluation and national quantification of reagents o Strengthen the bio-medical equipment maintenance capacity by training of personnel and procurement of tool kits. The region will use this cooperative agreement to maintain the regional laboratories, and VL/EID testing facility including back-up power, air conditioning, and negative pressure systems o Monitor sample referral network in the region as part of triparty agreement between the region, o Ethiopian Public Health Institute (EPHI) and Ethiopia Postal Service Enterprise.

The region will train laboratory personnel on sample referral and monitor network performance. The RHB will procure sample transportation and storage materials to strengthen sample referral network, and update network as needed o Maintain laboratory information system installed by EPHI, strengthen data management and data use for program improvement

STRATEGY 2: Provide high impact HIV prevention services including targeted HTS/high yield testing modalities and linkages, PrEP for high risk populations in priority SNUs, services for adult, pediatric, and KP and PP as well as support to GBV survivors

Provide safe and ethical index case services ensuring confidentiality of client information Avail HIV self-testing services to high risk and the hard to reach populations Utilize HIV risk screening tool to optimize provider-initiated counseling and testing

(PICT)

Deliver PITC service targeting adult inpatients & outpatients with presumptive/confirmed

TB, STI, OIs, or other symptoms suggestive of HIV/AIDS at supported sites Provide PITC to HIV orphans, HIV-exposed children, children with malnutrition, TB, OIs or other symptoms suggestive of HIV/AIDS at supported sites Educate and implement PLHIV/STI partner services to break the transmission cycle of

HIV within sexual networks Provide client-initiated testing (voluntary counseling and testing) to clients with perceived risk of exposure to HIV Provide training on HTS to counselors using national training curriculum Refer, link and track newly identified PLHIV to treatment services Enhance facility-level HIV case detection and linkage activities through regular monitoring and establishing site level accountability for targets Implement and document HTS quality assurance (QA) activities at supported HIV testing and counseling (HTC) sites Conduct quarterly supportive supervision or mentorship to all supported HTC sites Strengthen KP appropriate service including; Comprehensive HIV service, Peer navigator activities such as demand creation for service and retention, social networking (SNS) strategy for KP and their social networks, Provide supplies, equipment and other necessary materials for KP clinics

Provide KP/PP tailored trainings to HCWs based on the national guideline Avail necessary tools to monitor the activities and utilize extended working hours Provide condom promotion, demonstration, and access to STI and other high-risk patients and PLHIV o Make available condoms and tools for condom promotion and education such as penile model, information, education and communication/behavioral change communication (IEC/BCC) materials, and job aids and ensure that they are readily available at the site o Conduct supportive supervision visit integrated with other HIV program areas

Prep o Scale-up PrEP service to all clinics that provide appropriate services for KP and high load ART sites o Provide PrEP service to eligible HIV negative clients such as HIV negative female sex workers (FSWs) and partners of sero-discordant couples including pregnant women and lactating mothers o PrEP training will be provided to health care providers and pharmacy staff data clerks, case managers, to all KP appropriate clinic in the Region and high load ART sites in the Region o Scale-up PrEP demand creation activities to key and priority populations through peer navigators and IEC materials and media o Continue Monitoring and mentorship of the PrEP implementation to key and priority populations in the Region

GBV Prevention Activities o Provide GBV training for all health care workers and other program staff who have a role in provision of services/ referrals for survivors of GBV o Avail Standard Operating Procedures (SOPs) and guidelines on GBV care at relevant service outlets o Provide age appropriate comprehensive post violence care services for GBV survivors o Ensure functional referral system and referral directory for GBV survivors to get necessary care including legal, shelter, support groups and other as required o Provide education aimed at reducing the occurrence of GBV through interpersonal communication and media o Ensure proper documentation (including medical and forensic evidence) of GBV services & reporting GBV data as per the MER requirement o Screening and counselling for potential GBV survivors within HIV prevention, care and treatment setting o Support interpersonal communication and print & distribute job aids, IEC/BCC materials & update guidelines on GBV to strengthen prevention and improve service uptake for survivors o Improve quality of clinical post GBV care through routine program monitoring and QA tool in collaboration with CDC, relevant CDC funded partner, and TRHB o Strengthen youth appropriate services in supported high case load facilities through active screening to identify potential survivors and provide service

STRATEGY 3: Implement data-driven activities at Health Facilities (e.g., facility as well as Community-led monitoring efforts, data and service QI) and strengthen M&E capacity and data use at all levels of health systems within the region including but not limited to case-based surveillance related activities

Provide TA to cascade the National HIV Service QI Framework to health facilities Support a full-time QI manager that could oversee QI implementation at health facilities Build the capacity of woreda HIV team to coordinate and manage QI implementation at health facilities Support health facilities to set priorities to identify specific areas for improvement from national HIV service standards, health management information system (HMIS), Site Improvement through Monitoring System (SIMS), clinical audit, and patient surveys/feedbacks

Conduct facility-based bi-annual regional review meetings on QI implementation Strengthen the site-level use of data for program improvement Implement regular QI activities at ART sites Develop strategies to disseminate HIV QI results and findings Provide TA to health facilities to develop tailored SOPs for HIV QI implementation based on national standards Support health facilities to implement model for improvement along the HIV continuum of care (testing and linkage, retention and adherence, and VL suppression) in line with UNAIDS’ three 90’s goals

Assign and train dedicated M&E officers, data managers, data clerks and health information technicians (HITs) to monitor and report the quality and performance of programs at every level of the health systems

Ensure the assigned M&E staff, data manager/IT and HITs/data clerks are trained on electronic health management information system (HMIS), HMIS, electronic medical record (EMR)-HIV ART Module, EMR-MRU, PEPFAR MER 2.0 strategies, data QA, computer software and hardware including accessories, troubleshooting, maintenance, and proper data use and reporting

Conduct regular/periodic review meetings and address shortcomings pertinent to data quality, performance of PEPFAR programs, and HIV surveillance activities

Conduct site-level data support activities for the public and private health facilities in scale-up and sustained woredas on which TRHB collects, collates, uses, and reports monthly, quarterly and annually as appropriate as per the PEPFAR requirements, including for federal and university hospitals

Ensure proper planning and gap filling procurement of necessary computer hardware software accessories, and network infrastructure materials including anti-virus software to protect and secure HIV-related data at all PEPFAR-supported sites

Collaborate with the HMIS TA partner to upgrade and maintain electronic integrated databases to facilitate and manage M&E, and deploy/customize regional survey/surveillance related databases and data exchange systems for surveillance activities

Collaborate with the Transition TA partner to use the Regional Data Center for HIV AIDS service data generated at sites, for compilation and reporting, as well as for performance monitoring and QI

Develop and implement data quality strategies to address the gap observed in monitoring ART program

Support PMTCT, TB/HIV, STI, and HIV Case-Based Surveillance activities by providing cascaded trainings to sentinel site staff and zonal/woreda surveillance officers, print, distribute, and supervise data collection, supporting specimen transport to testing sites as per the standard surveillance guideline

Collaborate with EPHI for all national surveys/surveillances by timely submission of reports, ensuring the quality of surveillance data, and promoting data use

Document the TRHB strategic information (SI) activities and share best practices Coordinate with community-led monitoring activities to monitor, triangulate and use data for program improvement

STRATEGY 4: Build the capacity of HCWs to provide quality HIV and TB data and services

Build capacity of ART providers through training, case-based discussions, etc Strengthen the ART site Multi-Disciplinary Teams (MDTs) Conduct data-driven monitoring of the availability of adequate staffing and skill mix in high HIV volume facilities Strengthen facility-based human resource information system (including in-service training database) at priority SNUs Provide need based in-service trainings for front-line HCWs on all programmatic area based on national guidelines Strengthen workforce development by participating and supporting virtual communities of practice, e.g., Ethiopia ECHO related activities

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 programs and CDC-funded organizations:

The recipient will be expected to collaborate with CDC and with other CDC-funded IPs for efficient use of resources and maximum program impact through a partner’s coordination forum.

To adequately achieve the activities described, the recipient is expected to also collaborate with other IPs in specific program areas shown below to achieve the objectives of the NOFO as follows:

FMOH and its agencies: to ensure allocation of rapid test kits (RTKs), VL testing, ARVs, Isoniazid (INH) based on target and availing the RTKs ahead of time, development and distribution of guidelines and policies, program review, and supportive supervision, surveillance, and survey activities. Also collaborate with FMOH in the implementation of project ECHO to improve quality of data

EPHI: related to laboratory and surveillance and survey activities Local universities in connection with in-service and pre-service training and other TA National HMIS TA provider on HMIS issues and other data reporting issues Consult with CDC HQ and CDC-Ethiopia to perform programmatic activities and deliverables

b. With organizations not funded by CDC:

The recipient will be expected to collaborate with civil societies operating in the region, as well as, collaborate with UNAIDS to ensure the use of the most updated guidelines and global targets and UNICEF on getting therapeutic foods for HIV patients. The recipient should collaborate with different PEPFAR and non-PEPFAR stakeholders working on HIV/AIDS, community-led monitoring activities, and other related programs to coordinate and leverage program resources.

The recipient should provide strategies and activities that would be implemented with other partners and stakeholders.

2. Target Populations The target populations for the different activities supported through this NOFO include:

HTS: adult inpatients and outpatients with suspected or confirmed TB, STI, OIs, or other symptoms suggestive of HIV/AIDS at supported sites; HIV orphans, children with malnutrition, TB, OIs, or other symptoms suggestive of HIV/AIDS at supported sites;

clients with perceived risk of exposure to HIV and sexual partners of STI patients;

partners and HIV-exposed children of PLHIV and pregnant mothers

Adult Treatment: all PLHIV in Tigray Region and surrounding localities including KPs, high risk people who are social or sexual network members of KPs, and sero-discordant couples

Adult Care and Support: adult PLHIV accessing chronic HIV/AIDS care services at health facilities under the TRHB

TB/HIV: clients with presumed and confirmed TB as well as PLHIV in care; partners and contacts of persons with both TB and/or HIV; as well as prison inmates, persons living in congregate settings and KP

PMTCT: all pregnant women, their partners and HEIs accessing PMTCT/maternal, neonatal, and child health (MNCH) services at public and provide health facilities in scale up and sustained geographic locations in Tigray Region

Pediatric treatment, care and support: children accessing HIV/AIDS care and treatment services at health facilities in the scale-up and sustained geographic locations in Tigray

Health System Strengthening: the RHB’s Human Resources (HR) and Regulatory Departments, zonal, woreda, and health facility HR offices and personnel working in these departments and offices

a. Health Disparities

N/A

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. Please review the following key points about component funding:

Component funding must be setup at the time of the application.

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 SF-424A as part of their application which shows all components for the budget period and 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-424s will be needed.

Any component that is not funded at the time of 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 or effective statute.

o Components do not have to 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. Awarded component funds may be redirected within component object class categories.

It is critical to ensure programmatic performance of all U.S. taxpayer dollars. When developing the annual work plan, please be advised that the FY2021 COP 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 $5,000,000 with the below listed components.

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. For Example:

Component 1 - COP21 Q1 Targets/Activities;

Component 2 - COP21 Q2 Targets/Activities;

Component 3 - COP21 Q3 Targets/Activities;

Component 4 - COP21 Q4 Targets/Activities;

Component 5 - COP21 Additional Targets/Activities.

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 It is the intention of CDC that performance data need to be reviewed, cleaned, and used for program management and monitoring; to this effect the recipient should hold regular review meetings to discuss performance and also use the data in the program QI activities.

The recipient may allocate up to 5% of their budget for evaluation and 10% for performance measurement and routine monitoring.

PERFORMANCE MONITORING

Performance measures will include both PEPFAR (MER) and non-MER indicators.