revised Full NOFO Foa_Content_of_CDC-RFA-GH-24-0098 (2).pdf

Centers for Disease Control and Prevention

Center for Global Health

Implementing Evidence-Based Prevention Interventions for Key and Priority Populations in the Republic of Rwanda under the President’s Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0098

02/05/2024

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-24-0098. 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:

Implementing Evidence-Based Prevention Interventions for Key and Priority Populations in the Republic of Rwanda 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)).

Amendment I: Questions and Answers (Q&A) and Additional Updates

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

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

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

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

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

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.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0098

E. Assistance Listings Number:

93.067 F. Dates:

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

2. Due Date for Applications:

02/05/2024 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 To achieve the Rwandan strategic plan’s 2027 goal of reducing new HIV infections by 15%, implementation of evidence-based HIV prevention activities among key populations (KP) targeted in Rwanda (e.g., female and male sex workers, men who have sex with men (MSM), transgender people (TG), and other emerging KP) is essential. This NOFO builds on past activities targeting KP and priority populations (PP) by focusing on PP closely related to KP (e.g., sexual partners of female and male sex workers, social networks of KPs, and adolescent girls and young women (AGYW)).

The NOFO will focus on outreach services to KP/PP, provision of community-based peer education, and linkage to a comprehensive package of biomedical HIV prevention services (e.g., HIV testing services (HTS), pre-exposure prophylaxis (PrEP), condoms and voluntary medical male circumcision (VMMC)), linkage to HIV care with same-day initiation, follow-up of KP who are HIV positive, and viral load suppression (VLS) as indicated in Rwanda’s HIV Guidelines. The NOFO is expected to support the provision of tailored KP-competent services through a combination of service delivery models. The NOFO also aims to reduce stigma and discrimination and to address gender-based violence (GBV) issues faced by KP/ PP. Key monitoring and evaluation (M&E) components will include routine program monitoring to track the progress on achieving the project period outcomes.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

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

e. Average One Year Award Amount:

$1,900,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $1,900,000. The expected number of awards is 1. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 30, 2024

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Rwanda has made significant progress in the HIV response and has stabilized HIV prevalence among the general population at 3%. The Rwanda Population-Based Survey HIV Impact

Assessment (RPHIA) of 2018-2019 showed progress toward achieving the 2030 UNAIDS 95- 95-95 global targets whereby 83.8% of people living with HIV know their HIV status, 97.5% among those HIV positive are on treatment, and 90.1% are virally suppressed. Despite progress made in Rwanda, KP are disproportionately affected by the HIV epidemic compared to the general population. The Rwanda strategic plan recognizes KP as populations that require particular attention to reduce new HIV infections, thus providing guidance to different stakeholders on tailored combinations of strategies and services to reduce their HIV risk. The 2020 Integrated Biological-behavioral surveillance survey showed national HIV prevalence among female sex workers (FSW) was 35.5%, which is more than 11 times higher than the prevalence in the general population (3%). The 2021 MSM Integrated Bio-behavioral survey (IBBS) estimates HIV prevalence among MSM is 6.5%. MSM IBBS revealed gaps in the HIV treatment cascade for MSM showing only 44.6% of MSM living with HIV knew their HIV-positive status, and 75.6% of those on anti-retroviral treatment (ART) were virally suppressed.

Multiple factors, such as stigma and high mobility provide challenges to effective prevention and treatment interventions for KPs. AGYW engage in sexual high-risk behaviors including an increased number of sexual partners and low condom use. The Rwanda Demographic and Health Survey 2019-20 indicates that AGYW have low HIV comprehensive knowledge (58%), and 10% reported having sexual intercourse with a person who neither was their husband nor lived with them, and less than half (46%) reported using a condom during the last sexual intercourse 12 months prior to the survey. RPHIA showed a high level of HIV prevalence among AGYW compared to their male counterparts: 0.6% versus 0.4% among women and men aged 15-19 and 1.8% versus 0.6% for women and men aged 20-24 years, respectively.

This NOFO is expected to build on past and current activities targeting KP and PP to enhance the implementation of evidence-based HIV prevention interventions to close the remaining gaps among KP and PP, including FSW, AGYW in the KP network, MSM, TG, and other emerging KP and PP groups. Particular attention will be put on KP who do not disclose their identity (hidden KP), young members of KP, and HIV case finding among children of HIV-positive

FSW.

The goal of this NOFO is to implement a combination of strategies to prevent HIV among KP and PP, with an emphasis on evidence-based behavior change and biomedical interventions. The recipient is expected to implement a mix of approaches for the widespread dissemination of messages that encourage KP and PP to reduce the risk of acquiring and transmitting HIV infection at both the individual and group levels.

This NOFO aims to optimize access to and use of HIV prevention and treatment services among KP and PP. The recipient is expected to implement case-finding strategies to reach KP and PP and provide them with HTS through different testing modalities, facilitate linkage and referrals of HIV-positive KP and PP to treatment and care services, and linkage of HIV negative individuals to appropriate HIV prevention services. The recipient is expected to engage KP and PP communities in the program's design, delivery of services, and M&E to ensure that planned interventions are tailored to their needs.

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 The expiring NOFO, CDC-RFA-GH19-1940, supported PEPFAR KP and PP programs by reaching 31,569 FSW, about 9,715 MSM, and 16,749 PP by the end of COP21. KP/PP services were provided in 90 health facilities distributed across 23 districts of Rwanda. The prioritized KP includes FSW, MSM, and TG, while prioritized PP includes people who are connected to KP, such as sexual partners of female and male sex workers, social networks of KP, and AGYW. The NOFO provided interventions focusing mainly on HIV case findings through different HTS modalities such as community mobile, community index, and social network strategy. Eligible KP and PP for VMMC, Prevention of Mother to Child Transmission of HIV, PrEP, and post-exposure prophylaxis (PEP) are linked to health facilities for initiation and follow-up of these interventions. KP also received other commodities, such as HIV self-test kits, condoms, and lubricants. Additionally, KP and PP who tested HIV positive were linked to health facilities for ART initiation and follow-up to ensure viral suppression.

The NOFO utilized virtual outreach models, providing HIV prevention information through established digital channels such as the use of a website called Mbaza “Ask me” and two social media handles (Facebook and Instagram) to reach KP/PP that have digital devices with access to the internet. These platforms increased awareness and knowledge of HIV prevention services and encouraged KP to book an appointment for services provided by health facilities on the web locator.

The lesson learned was that close collaboration with health facilities enabled the successful linkage of KP/PP to biomedical prevention interventions and ART initiation for those who test HIV positive. Additionally, the empowerment of KP communities through training, meaningful engagement of KP peer educators in service delivery, and program improvement through listening sessions were essential to the successful implementation of the expiring NOFO.

This NOFO will build on past and current program activities prioritizing KP and PP, which aligns with the national HIV strategic plan’s priority for providing KP with combined HIV and sexual reproductive health services to achieve the national goal of reducing new HIV infections by 15% in 2027. The Rwanda HIV guidelines recommend a continuum of HIV-related prevention and treatment services for KP and PP; thus, this NOFO will refer to it in the delivery of the HIV package of services for KP and PP.

The focus of this NOFO is expected to be on the implementation of effective and targeted case finding among KP/PP and linkage to HIV services; the enhancement and expansion of comprehensive community-based HIV prevention services through meaningful involvement of KP communities in peer education, condoms and lubricant distribution; linkage to other biomedical prevention services (e.g., PrEP, PEP, VMMC, STI screening and management); and adherence support for HIV positive KP to ensure that they are virally suppressed.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1:

Plan, provide, and coordinate effective case finding and linkage strategies to reach KP/PP

Strategy 2:

Develop, provide, and expand tailored, quality HIV prevention services to reach and meet KP/PP needs

Strategy 3:

Strengthen capacity for collection and use of high-quality M&E, epidemiologic, and surveillance data for KP/PP programming

Increased targeted testing of KP/PP through effective implementation of evidence-based HIV testing modalities

Increased linkage to appropriate prevention, care, and treatment services for KP/PP

Improved HIV-related knowledge and risk awareness among

KP/PP

Increased availability of combination HIV prevention services among KP/PP

Improved awareness and acceptance of PrEP

Improved awareness and acceptance of VMMC services for

Increased capacity of healthcare providers to deliver KP-competent, stigma-free services

Increased HIV case identification through targeted testing for

Increased retention across the continuum of HIV prevention, care, and treatment

Increased coverage of HIV prevention, care, and treatment services among

Increased uptake of HIV prevention, care, and treatment services among

PrEP services among

VMMC services among KP/PP

Increased routine collection and use of high-quality M&E, epidemiologic, and surveillance data to

Decreased new HIV infection rates among

Increased HIV VLS rate

Improved protection of KP programming data from unauthorized access and use

Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

Increased staff capacity for collection and use of high-quality M&E, epidemiologic, and surveillance KP/PP data

Improved data management security of KP/PP data inform KP/PP HIV programming

Increased security in data collection, storage, and reporting

i. Purpose The purpose of this NOFO is to close HIV testing gaps among KP and PP, ensure appropriate linkage to evidence-based prevention and treatment services, and promote equity in service access to reduce new HIV infections, morbidity, and mortality in Rwanda.

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 targeted testing of KP/PP through effective implementation of evidence-based HIV testing modalities

• Increased linkage to appropriate prevention, care, and treatment services for KP/PP o Linkage to appropriate prevention, care, and treatment services refers to linkage to prevention services for HIV-negative KP/PP and to care and treatment services (e.g., ART initiation) for HIV-positive KP/PP

• Improved HIV-related knowledge and risk awareness among KP/PP

• Increased availability of combination HIV prevention services among KP/PP o Combination HIV prevention services includes but is not limited to condoms and

VMMC

• Improved awareness and acceptance of PrEP services for KP/PP

• Improved awareness and acceptance of VMMC services for KP/PP

• Increased capacity of healthcare providers to deliver KP-competent, stigma-free services

• Increased staff capacity for collection and use of high-quality M&E, epidemiologic, and surveillance KP/PP data

• Improved data management security of KP/PP data

Intermediate Outcomes:

• Increased HIV case identification through targeted testing for KP/PP

• Increased retention across the continuum of HIV prevention, care, and treatment services for KP/PP

• Increased coverage of HIV prevention, care, and treatment services among KP/PP

• Increased uptake of HIV prevention, care, and treatment services among KP/PP

• Increased uptake of PrEP services among KP/PP

• Increased uptake of VMMC services among KP/PP

• Increased routine collection and use of high-quality M&E, epidemiologic, and surveillance data to inform KP/PP HIV programming

• Increased security in data collection, storage, and reporting

Long-Term Outcomes:

• Decreased new HIV infection rates among KP/PP

• Increased HIV VLS rate

• Improved protection of KP programming data from unauthorized access and use

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

Strategy 1: Plan, provide, and coordinate effective case finding and linkage strategies to reach KP/PP

• Conduct community mobilization and demand creation activities to improve uptake of

HTS

• Provide HTS prioritizing KP and PP, their social networks and children through community and facility-based testing modalities

• Establish collaboration with health facilities to facilitate facility-based testing and linkage to other clinical prevention services (e.g., VMMC and PrEP), HIV treatment, and GBV services

• Engage and build capacity of people from KP in the design and delivery of HTS

• Implement existing and new strategies to improve linkage to the continuum of HIV prevention and treatment services, and STI screening and management

• Develop standard operating procedures and tools that provide technical guidance on KP service delivery

• Establish feedback systems between KP and healthcare providers to capture best practices and issues in services delivery

Strategy 2: Develop, provide, and expand tailored, quality HIV prevention services to reach and meet KP/PP needs

• Provide information, education, and communication about HIV-competent services for KP/PP using different platforms

• Develop and implement community mobilization and outreach to promote and increase demand for and uptake of HIV services for KP/PP, including but not limited to daily oral PrEP and other alternative options, condoms, and VMMC

• Collaborate with health facilities to ensure that KP/PP have access to safe, effective, and high-quality HIV prevention services (e.g., PrEP, VMMC, etc.), linkage to care and treatment services, and mental health and psychosocial support

• Facilitate healthcare provider’s training to deliver existing and new HIV prevention services for KP/PP that are non-judgmental and maintain confidentiality

• Build the capacity of health providers on STI education, screening, and treatment among MSM to provide KP-competent services

• Train KP peer educators to reinforce prevention messaging through peer education services

• Support KP peer educators in delivering community-based peer education, condoms, and lubricants

• Organize engagement meetings between KP/PP beneficiaries and healthcare providers to get beneficiaries’ feedback and inform program improvement

• Engage HIV-positive KP to improve retention and adherence to treatment

Strategy 3: Strengthen capacity for collection and use of high-quality M&E, epidemiologic, and surveillance data for KP/PP programming

• Build capacity of data managers to enhance their skills in data quality and reporting

• Conduct regular data collection, analyze the data, and use the data to inform program decision-making and implementation

• Develop and routinely update data collection and monitoring tools to support programmatic improvement

• Prepare and submit routine program reports to track implementation progress

• Conduct regular hotspot identification and mapping, population size estimation activity, and surveys on specific KP/PP program areas to inform program decision-making and implementation

• Integrate effective data quality assessment activities to ensure the collection of high-quality data

• Establish a system that ensures data security and confidentiality for KP/PP data

• Organize training of data managers on data security and privacy in healthcare

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 of this NOFO will be expected to work with CDC-funded MOH and international programs to identify and provide evidence-based prevention interventions for KP and PP and to monitor program outcomes. Further, the recipient is expected to work with public and private health facilities to provide comprehensive HIV prevention services to KP/PP, including HIV case finding among KP/PP, and enroll all newly identified HIV-positive KP/PP into care and treatment services. Additionally, HIV case findings will be prioritized for children of HIV-positive FSW. For this, the recipient will engage and collaborate with Orphan and Vulnerable Children partners in the area in which they will operate. The recipient is expected to work closely with other CDC-funded organizations to ensure KP/PP have access to other services, including STI and TB screening and treatment, and GBV prevention and management services.

b. With organizations not funded by CDC:

The recipient will be expected to work closely with other non-CDC-funded PEPFAR agencies that include community-based organizations, civil society organizations, KP associations and networks, United Nations organizations and other stakeholders to close the remaining gaps among KP/PP and to improve case-finding through outreach/mobile HTS, improve access to comprehensive community-based HIV prevention services, and enhance referrals and management of GBV cases. The recipient will be expected to engage with community and civil society organizations to enhance community led KP and PP programming monitoring.

2. Population(s) of Focus The populations of focus for this NOFO include but are not limited to female and male sex workers, sexual partners of female and male sex workers, AGYW, MSM, TG, and other emerging high-risk groups.

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 $1,900,000 with the below listed components:

• Component 1: COP Q1 Targets/Activities;

• Component 2: COP Q2 Targets/Activities;

• Component 3: COP Q3 Targets/Activities;

• Component 4: COP Q4 Targets/Activities;

• Component 5: COP Additional Targets/Activities;

• Component 6: Emerging Health Priorities (buffer component if needed).

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 is expected to report on a quarterly basis the number of HIV tests conducted, the number of new HIV cases identified, the number of self-testing kits distributed, the number of FSW and MSM initiated and retained on PrEP and the number of HIV-positive KP initiated on ART. On a semi-annual basis, the recipient is expected to report on the number of KP and PP reached by HIV prevention interventions.

The recipient should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient, a minimum of 5% of funds should be allocated for monitoring activities and 5% 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:

• KP_PREV: Number of key populations reached with individual and/or small group-level HIV prevention interventions designed for the target population [Target: 42,000;

Reporting Frequency: Semi-annual]

• PP_PREV: Number of priority populations (PP) reached with standardized, evidence-based intervention(s) required that are designed to promote the adoption of HIV prevention behaviors and service uptake [Target: 16,751; Reporting Frequency: Semi-annual]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results [Target: 47,884; Reporting Frequency: Quarterly]

• HTS_TST_POS: Number of individuals who received HIV Testing Services (HTS) and received a positive test result [Target: 1,316; Reporting Frequency: Quarterly]

• HTS_SELF: Number of individual HIV Self -test kits distributed [Target: 27,819;

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: 5,571;

Reporting Frequency: Quarterly]

• PrEP_CT: Number of individuals, excluding those newly enrolled, that return for a follow up visit or re-initiation visit to receive pre-exposure prophylaxis (PrEP) to prevent HIV during the reporting period [Target: 4,227; Reporting Frequency: Quarterly]

• HTS_INDEX: Number of individuals who were identified and tested using index testing services and received their results disaggregated by gender and age [Target: 3,000;

Reporting Frequency: Quarterly]

Non-MER: Additional Performance Measures (Custom Indicators)

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

• Proportion of previously diagnosed HIV-positive KP/PP disaggregated by gender and age [Target: 100%; Reporting Frequency: Quarterly]

• Percentage of previously undiagnosed with HIV KP/PP disaggregated by gender and age [Target: 100%; Reporting Frequency: Quarterly]

• Number of newly tested HIV-positive KP/PP disaggregated by gender and age [Target:

1,054; Reporting Frequency: Quarterly]

• Numbers of HIV-negative KP reached with HIV comprehensive package of services (e.g., condoms, lubricants) [Target: 40,740; Reporting Frequency: Quarterly]

• Percentage of KP linked to health facility who are newly enrolled on ART [Target:

100%; Reporting Frequency: Quarterly]

• Percentage of health facilities with PrEP available for KP/PP [Target: 100%; Reporting Frequency: Quarterly]

• Percentage of health facilities with PEP available for KP/PP [Target: 100%; Reporting Frequency: Quarterly]

• Percentage of MSM (who seek HIV services) linked to health facilities for circumcision services [Target: 100%; Reporting Frequency: Quarterly]

• Percentage of sexual partners of FSW (who seek HIV services) linked to health facilities for circumcision services [Target: 100% Reporting Frequency: Quarterly]

• Percentage of KP/PP (who seek HIV services) who received GBV related services [Target: 100% Reporting Frequency: Semi-Annually]

Data Sources for MER and Custom Indicators: Data sources may include registers, tally sheets, electronic and paper patient records, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

Evaluation

The evaluation topics below are examples of areas that the recipient may be expected to answer through process or outcome evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation topic areas. The recipient will be expected to conduct amid-term and/or end-year evaluation.

Sample Evaluation Topics:

• Facilitators and Barriers to HIV diagnosis and linkage of KP/PP to HIV care and treatment services [Process Evaluation]

• PrEP program effectiveness [Outcome Evaluation]

Evaluation Data Sources: Data sources may include registers, tally sheets, electronic and paper patient records, recipient progress reports, focus groups, in-depth interviews, surveys, and other program monitoring tools.

Dissemination of Evaluation Results: Dissemination channels may include local and international conferences and forum abstract presentations, conference poster displays, manuscripts, bulletins, reports, presentations to technical working groups and stakeholder meetings, and other approved products in print and electronic media.