CDC-RFA-PS23-2302 FINAL.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION

Accelerating the Prevention and Control of HIV, Viral Hepatitis, STDs, and TB in the U.S.

Affiliated Pacific Islands

CDC-RFA-PS23-2302

07/31/2022

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- PS23-2302. 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:

Accelerating the Prevention and Control of HIV, Viral Hepatitis, STDs, and TB in the U.S.

Affiliated Pacific Islands

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)).

New

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS23-2302

E. Assistance Listings Number:

93.116

F. Dates:

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

N/A

2. Due Date for Applications:

07/31/2022 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

An informational call will be held on June 28, 2022 at 7:00pm (EST) Link to join call: https://www.zoomgov.com/webinar/register/WN_JV9XwkiuQ_ugCXh-iv5EOQ Slides will be posted to the PS23-2302 website after the call here: https://www.cdc.gov/nchhstp/funding/usapi/

G. Executive Summary:

1. Summary Paragraph The six U.S.-Affiliated Pacific Island (USAPI) jurisdictions (Commonwealth of the Northern Mariana Islands [CNMI], American Samoa, Guam, Federated States of Micronesia [FSM], the Republic of the Marshall Islands [RMI] and Republic of Palau) experience challenges with prevention, care, and treatment of Human Immunodeficiency Virus (HIV), viral hepatitis (VH), sexual transmitted disease (STD), and tuberculosis (TB). The challenges presented by remote geographic location, dispersed populations, and lack of resources are exacerbated by insufficient and fragmented surveillance systems, laboratory testing and intervention capacity, and access to medications. People in these jurisdictions are disproportionately affected by TB and STDs and are potentially at increased risk for HIV infection. In addition, there is evidence suggesting high rates of VH.

The National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) has developed an integrated notice of funding opportunity (NOFO) to:

Improve efficient use of resources through the integration and coordination of prevention, screening, and treatment programs for HIV, VH, STDs, and TB Reduce health disparities and adverse outcomes among persons in the USAPI jurisdictions Improve public health care infrastructure, delivery of public health care, laboratory capacity, and the public health workforce to prevent, diagnose, and treat HIV, VH, STDs, and TB Reduce incidence of morbidity and mortality from HIV, VH, STDs, and TB

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$19,500,000

e. Average One Year Award Amount:

$650,000

f. Total Period of Performance Length:

g. Estimated Award Date:

December 01, 2022

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 USAPI jurisdictions experience challenges with prevention and control of HIV, VH, STDs, and TB. The combination of disproportionate or unknown disease burden, broadly dispersed populations, lack of infrastructure, and insufficient and fragmented surveillance, laboratory, and healthcare systems result in public health challenges including limited routine screening and testing for infectious diseases.

In 2019, the HIV rate in the U.S. was 13.2 per 100,000 persons, compared with 4.9 per 100,000 persons in the USAPI jurisdictions (excluding FSM, and RMI). Though HIV rates are lower in the USAPI jurisdictions, high rates of STDs are a cause of concern because they increase the risk for HIV infection.

There is no ongoing VH surveillance in the USAPIs, so prevalence of chronic hepatitis must be estimated. The World Health Organization (WHO) Western Pacific Region has the highest prevalence of Hepatitis B Virus (HBV) at 6.2%.2

In 2019 in the USAPIs, the total rate of reported cases of chlamydia was 534.4 per 100,000, gonorrhea was 121.6 per 100,000 and primary and secondary syphilis was 3.2 per 100,000, compared to the US total rate of 552.8, 188.4 and 11.9, respectively. Although lower than the reported case rates in the continental US, these infections continue to challenge the health and wellness of thousands of people in the USAPI jurisdictions.

During 2020, 341 TB cases were reported by the USAPI jurisdictions (74.2 cases per 100,000).

The TB incidence rate of each USAPI jurisdiction exceeded the US national incidence rate of 2.2 per 100,000. Reported incidence rates per 100,000 persons were 6.3 for American Samoa, 33.8 for Guam, 75.2 for CNMI, 50.0 for the Republic of Palau, 73.7 for FSM, and 252.5 for RMI. The US state with the highest incidence reported 7.9 cases per 100,000; five of the USAPI jurisdictions reported higher incidence.

This NOFO supports the NCHHSTP strategy to increase program collaboration and service integration (PCSI) through enhanced engagement, knowledge sharing, integration across prevention and treatment services, and consolidated administrative processes. This NOFO will contribute to advancing NCHHSTPs’ Health Equity Implementation Plan including reducing health disparities within the USAPIs by developing a well-trained workforce and increasing access to diagnostic testing for populations disproportionately affected by HIV, VH, STD and TB. The NOFO will support recipients to:

Implement PCSI to capitalize on opportunities to perform diagnostic testing, treat, and prevent infections in persons with similar risk factors Improve the collection, reporting, use, and sharing of surveillance data Develop public healthcare workforce through training and education.

Strengthen laboratory quality management systems and improve capacity to conduct reliable, accurate, and timely testing Enhance prevention, care, and treatment for disease-specific activities

References

1. CDC. HIV Surveillance Report, 2019; vol.32. http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Accessed Dec 14, 2021.

2. WHO. Global hepatitis report 2017. www.who.int/hepatitis/publications/global-hepatitis-report2017 .Accessed Dec 14, 2021.

3. CDC. Sexually Transmitted Disease Surveillance 2019. Sexually Transmitted Disease Surveillance, 2019 (cdc.gov). Accessed Dec 14, 2021.

4. CDC. Reported Tuberculosis in the United States, 2020.

https://www.cdc.gov/tb/statistics/reports/2020/default.htm. Accessed Dec 14, 2021.

b. Statutory Authorities Human Immunodeficiency Virus, Viral Hepatitis, Sexually Transmitted Disease and Tuberculosis prevention programs are authorized under the following Sections of the Public Health Service Act: 317(k) (2); 317 E (a) and (b); and 318 (a), (b), and (c) (42 U.S.C. Sections 247b; 247b-6; 247c (a) (b) and (c)), as amended. Regulations governing the implementation of this legislation are covered under 42 CFR Part 51b, Subpart A.

c. Healthy People 2030 This NOFO addresses the Healthy People 2030 focus areas of HIV, Viral Hepatitis, STDs, and TB including:

Reduce the number of new HIV infections (HIV-01) Increase knowledge of HIV status (HIV-02) Increase linkage to HIV medical care (HIV-04) Reduce the rate of acute hepatitis B (IID-11) Increase the proportion of sexually active female adolescents and young women who get screened for chlamydia (STI-01) Reduce the syphilis rate in females (STI-03) Reduce congenital syphilis (STI-04) Reduce the syphilis rate in men who have sex with men (STI-05)

Reduce tuberculosis cases (IID-17)

For more details: https://health.gov/healthypeople/objectives-and-data

d. Other National Public Health Priorities and Strategies National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan

National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Equity Initiative

National HIV/AIDS Strategy

National Strategic Plan: A Roadmap to End the Epidemic for the United States 2021-2025

Viral Hepatitis National Strategic Plan

Division of Viral Hepatitis 2025 Strategic Plan

U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025

e. Relevant Work This NOFO builds upon CDC-RFA-PS13-1301 and CDC-RFA-PS18-1801, “Accelerating the Prevention and Control of HIV, Viral Hepatitis, STDs, and TB in the U.S.-Affiliated Pacific Islands."

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: Program Collaboration and Service Integration (PCSI):

Implement integrated services in high priority settings.

Increased receipt of testing and treatment for multiple diseases as clinically indicated among patients

Increased awareness of HIV, VH, STD, & TB infection status among patients

Strategy 2: Surveillance, Data Management, and Reporting: Collect, manage, and implement quality assurance processes for data, Increased complete and timely data reporting for USAPIs

Improved prevention programs & service delivery for disproportionately affected populations

Improved integration & coordination of resources for preventing and treating HIV, viral hepatitis, STDs, & TB

Reduced health disparities and inequities among and use data to drive public health action Increased knowledge and skills in data security and confidentiality across programs

Increased data sharing and use across programs

Strategy 3: Workforce Development: Build public health workforce capacity & develop policies and procedures to support PCSI

Improved public healthcare workforce skills to deliver prevention, screening, and care services for HIV, hepatitis B, STDs, & TB

Increased culturally appropriate diagnosis & treatment capacity

Strategy 4: Laboratory Strengthening: Deliver reliable, accurate, and timely public health laboratory testing services and ensure strong laboratory quality management systems

Improved availability of laboratory supplies within expiration date Improved availability of high-quality laboratory testing services

Decreased turnaround times for HIV, hepatitis B, STDs & TB testing

Increased laboratory efficiency from implementation of evidence-based policies/ procedures & enriched collaborations supporting laboratory quality management systems.

Strategy 5: Disease-Specific Prevention and Care: Conduct or facilitate prevention, testing, linkage to care, partner services, contact investigation, treatment and case management

Increased awareness of HIV, hepatitis B, and STD or TB infection

Increased timely linkage to care for persons diagnosed with HIV, hepatitis B, STDs & TB or to

Improved care outcomes for patients with diagnosed infection persons in the USAPIs

Sustained capacity of healthcare delivery systems, public health, and health workforce to prevent, diagnose and treat HIV, VH, STDs, & TB

Reduced new infections of and morbidity and mortality from HIV, VH, STDs, & TB prevention for persons testing negative

Increased receipt of case management for diagnosed persons

Increased receipt of partner services and completion of contact investigations

i. Purpose This NOFO will support the implementation of five core strategies to improve HIV, VH, STD, and TB prevention, testing, and treatment programs in the USAPI jurisdictions:

Program Collaboration and Service Integration in high priority settings and for disproportionately affected populations Surveillance, Data Management, and Reporting Workforce Development through training and education Laboratory Strengthening for reliable, accurate, and timely delivery of public health laboratory services Disease-Specific Prevention and Care including testing, linkage to care, and partner services

ii. Outcomes Strategy 1: Program Collaboration and Service Integration (PCSI)

Increased receipt of testing and treatment for multiple diseases as clinically indicated among patients

Strategy 2: Surveillance, Data Management, and Reporting

Increased complete and timely data reporting for USAPIs Improved prevention programs and service delivery among disproportionately affected populations

Strategy 3: Workforce Development

Increased public healthcare workforce skills to deliver prevention, screening, and care services for HIV, VH, STDs, and TB

Strategy 4: Laboratory Strengthening

Improved availability of laboratory supplies within expiration date Improved availability of high-quality testing services

Decreased turnaround times for HIV, hepatitis B, STD, and TB testing

Strategy 5: Disease-Specific Prevention and Care

Increased awareness of HIV, hepatitis B, and STD or TB infection Increased timely linkage to care for persons diagnosed with HIV, VH, STDs, and TB Increased receipt of partner services and completion of contact investigations Improved care outcomes for patients with diagnosed infection

iii. Strategies and Activities Recipients are expected to implement the following strategies and activities during the 5-year period of performance. However, applicants may propose additional strategies and activities (beyond what is included in the logic model) to achieve the outcomes. CDC will only receive de-identified data.

Strategy 1: Program Collaboration and Service Integration (PCSI)

To ensure activities under Strategy 1 are implemented, funded jurisdictions should designate a public health professional (100% of time) to serve as the PCSI Lead. Roles and responsibilities include:

Convene regular meetings (no less than quarterly) with the PCSI Steering Committee, which includes the PCSI Surveillance Coordinator, PCSI Laboratory Coordinator, financial official, and key staff from the laboratory, HIV, VH, STD, and TB programs.

Coordinate the PCSI activities required in this NOFO and participate on routine calls with CDC staff.

Identify and resolve barriers to implementing the PCSI strategies and activities required in this NOFO.

Activity 1.1: Implement integrated screening and testing in high priority settings

Collaborate with Maternal Child Health (MCH)/Antenatal Care (ANC) departments to ensure pregnant persons receive recommended testing for HIV, hepatitis B virus (HBV), chlamydia, gonorrhea, and syphilis. Additional guidance can be found at:

https://www.cdc.gov/nchhstp/pregnancy/screening/index.html and https://www.cdc.gov/std/treatment-guidelines/default.htm o Convene regular meetings to review screening data and address barriers (no less than quarterly).

Ensure follow-up and case reviews of all perinatal deaths in an effort to identify linkage with mother-to-child transmission of syphilis, HBV, and perinatal transmission of HIV.

Case reviews shall include staff from HIV, VH, STD, and MCH/ANC programs. The Fetal and Infant Mortality Review (FIMR)/HIV Prevention is a guide to assist with HIV perinatal case review. The Congenital Syphilis Case Investigation and Reporting Form is a guide to assist with mother-to-child transmission of syphilis case review. Additional guidance can be found at: https://www.cdc.gov/std/program/forms/Guidance-for-Case- Status Variable_clearance_cleared.pdf , https://www.cdc.gov/std/treatment-guidelines/clinical-reporting.htm and www.fimrhiv.org

Collaborate with Family Planning Services to prevent STD-related pelvic inflammatory disease (PID), ectopic pregnancy, and infertility Ensure treatment of persons with STIs and their partners Promote screening, diagnosis, and treatment recommendations and guidelines among providers

Activity 1.2: Integrate screening and testing of persons at risk for multiple diseases

Ensure recommended testing of pregnant persons for HIV, HBV, chlamydia, gonorrhea, and syphilis (during the same visit), once within their 1st trimester.

o If testing capacity allows, also screen for hepatitis A virus (HAV) and hepatitis C virus (HCV (antibody)) in addition to HBV (hepatitis B surface antigen (HBsAg))

Conduct HIV and diabetes testing on persons with TB disease and refer persons newly diagnosed with HIV and/or diabetes for services.

Conduct HBV, chlamydia, gonorrhea, syphilis, and TB screening (during the same visit), on persons newly diagnosed with HIV, and annually during routine follow-up care for persons living with HIV.

Ensure persons treated for chlamydia, gonorrhea, and/or syphilis are tested for HIV within 30 days.

Ensure testing for all persons seeking STI evaluation who are not already known to have HIV infection Conduct targeted HIV, chlamydia, gonorrhea, and syphilis testing among populations disproportionately affected, such as men who have sex with men, persons who inject drugs (PWID), transgender women, and commercial sex workers and their clients.

Strategy 2: Surveillance, Data Management, and Reporting

To ensure activities under Strategy 2 are implemented, funded jurisdictions should designate a full-time PCSI Surveillance Coordinator. Roles and responsibilities include:

Implement the current NCHHSTP Data Security and Confidentiality Guidelines.

Coordinate the surveillance, data management, and reporting activities required in this

NOFO.

Ensure HIV testing, VH, STD, and TB surveillance data are entered on a weekly basis into local surveillance systems.

Ensure HIV, VH, STD, and TB surveillance data are submitted to CDC by reporting deadlines.

Identify and resolve barriers to sharing and using data across programs.

Review surveillance data monthly to identify any potential outbreaks in any disease area, and ensure potential outbreaks are investigated immediately after identification.

Activity 2.1: Collect and manage surveillance and program data

Report surveillance and program data to CDC in required format by required deadlines.

HIV Surveillance: Within the first year of the award, if not already certified, the HIV Surveillance Programs must complete the HIV certification process to submit HIV Surveillance cases to the CDC, as authorized by the jurisdictions' public health reporting laws, and in compliance with the current Data Security and Confidentiality Guidelines.

o Recipients should mail the HIV case report form to CDC within 1 month from the laboratory report date of the first HIV-positive test results, and from subsequent laboratory results or change in vital status.

HIV Prevention: Follow the guidance in the Pacific Islands HIV Test Form Data Dictionary to be shared with recipients post award.

VH: Follow the Viral Hepatitis Surveillance and Case Management: Guidance for State, Territorial, and Local Health Departments. Atlanta, GA 2021 available at https://www.cdc.gov/hepatitis/statistics/surveillanceguidance/index.htm.

o Collect data on persons who test positive for hepatitis B surface antigen (HBsAg) to facilitate the notification, counseling and management of persons with chronic HBV infection.

o A copy of the original laboratory report indicating the pregnant person’s HBsAg status should be provided to the hospital or birthing facility where the delivery is planned and to the health provider who will care for the infant.

STD: Follow the Program Operations and Guidelines for STD Prevention and Data Management, available at https://www.cdc.gov/std/program/Surveillance.pdf o Develop surveillance activities to review and investigate all reports on all perinatal deaths, and to identify and complete reports for possible links with maternal syphilis and perinatal HIV.

TB: To accomplish the priority tasks of timely assessment and reporting of all confirmed TB cases; prompt detection and investigation of and response to possible TB outbreaks;

and identification of surveillance infrastructure gaps and system needs, recipients are expected to:

o Enhance identification, reporting, and follow-up of persons with confirmed or suspected TB by establishing collaborative relationships with appropriate reporting sources including:

Hospitals and clinics (e.g., TB and HIV/AIDS and STD clinics).

Laboratories performing testing for mycobacteria.

Healthcare providers (e.g., pulmonary and infectious disease subspecialists).

Correctional facilities.

Homeless shelters.

Community and migrant health centers.

Pharmacies.

Other public and private facilities providing care to populations at risk for

TB.

o Ensure complete, accurate, and timely reporting of persons with confirmed or suspected TB by:

Maintaining TB disease as a mandatory reportable condition to the extent as required by state and local laws.

Enhancing awareness among healthcare providers of the requirement to report TB cases.

Maintaining a passive surveillance data collection system that includes at least the data elements contained in the CDC Report of Verified Case of

TB (RVCT).

Conducting active surveillance for TB when warranted because of a known or suspected TB outbreak, or when there is reason to believe that passive surveillance is insufficient to identify all cases of TB.

o Notify CDC of TB cases in a complete, accurate, and timely manner by:

Maintaining an electronic data system for verified TB cases that is compatible with the National Electronic Disease Surveillance System (NEDSS) standards.

Reporting to CDC complete and accurate data on all TB cases (regardless of whether the cases are considered “countable” in official case counts) using the Report of Verified Case of Tuberculosis (RVCT). All RVCT data elements should be filled out completely according to CDC instructions for the RVCT.

Transmitting TB case notification messages via the National Notifiable Disease Surveillance System (NNDSS) or other CDC-approved system for all verified TB cases to CDC in a timely manner (within 1 week for newly verified cases and within 1 month for previously verified cases with updated information).

Ensuring that all RVCT data for a TB case, including treatment completion and outcome information, are submitted to CDC within 2 years of the initial case report.

o Ensure prompt identification and investigation of TB genotype clusters by:

Submitting at least one isolate from persons with culture-positive TB to a CDC-designated laboratory for genotyping in a timely manner.

Linking genotyping results to surveillance data as soon as possible and within 8 weeks of genotype results becoming available, either through the TB Genotyping Information Management System (TB GIMS) or by entering the genotyping laboratory accession number in the appropriate field on the RVCT according to best practices for TB genotyping:

www.cdc.gov/tb/publications/factsheets/statistics/Genotyping_BestPractic es.pdf Promptly reviewing (within 1 week of receiving notification) and collaborating with CDC to investigate TB genotype cluster alerts generated by TB GIMS to determine whether a TB outbreak is occurring.

o Ensure appropriate response to large TB outbreaks cases diagnosed in a 3-year period that are related by recent transmission) by:

Conducting timely and appropriate epidemiologic investigation of, and response to, TB outbreaks.

Reporting outbreak investigation and response activities to CDC at least monthly, including epidemiologic data and ongoing or planned interventions to control transmission (e.g., line lists of outbreak-related cases, epidemiologic links identified among patients, and results of contact investigations, including TB and latent TB infection (LTBI) treatment outcomes).

LAB: Implement and maintain activities to support complete laboratory reporting of HIV, HBV, chlamydia, gonorrhea, syphilis, and TB cases. Additionally, monitor trends in antimicrobial susceptibility profiles for STD (particularly, Neisseria gonorrhea), and TB.

Build and strengthen disaster recovery and business continuity plans for NCHHSTP data protections and maintenance.

o Within the first year, recipients should submit their disaster recovery and business continuity plans to a disaster recovery subject matter expert (SME) for review of data protections and maintenance.

o The disaster recovery SME should review the plans and provide support to recipients to eliminate and or reduce deficiencies for final plans as needed.

o Where the disaster recovery SME identifies a need for improvements, recipients should work with the disaster recovery SME and NOFO SME to make improvements for a final optimal plan.

Activity 2.2: Evaluate program effectiveness

Use surveillance and program data to assess effectiveness of screening, targeted testing, partner services/contact tracing, and treatment.

Activity 2.3: Implement quality assurance processes

Conduct quality assurance of surveillance data monthly to ensure data completeness, timeliness, and accuracy.

Additional information by program area:

o HIV Surveillance Conduct death ascertainment to identify deaths among all persons with HIV and identify persons with an HIV-related cause of death.

Conduct monthly intrastate de-duplication of HIV cases.

Complete routine interstate duplicate review (RIDR).

Conduct risk factor ascertainment for all cases of HIV infection, including prevalent cases annually in accordance with the Technical Guidance for HIV Surveillance.

o TB Develop or update annually a TB surveillance quality assurance plan as described in the CDC Quality Assurance for TB Surveillance Data Guide and Toolkit.

Use the National TB Surveillance System (NTSS) and National TB Indicators Project (NTIP) to conduct quality assurance of surveillance data and to monitor performance towards meeting National TB Program Objectives and Performance Targets.

o STD Collect, and manage and report, STD data.

Document the management information system tool used to collect STD data (e.g., Excel, NBS, etc.) using CDC recommended/approved data management information system report tools and program metrics.

Routinely evaluate ANC, MCH, and Family Planning data to ensure clients are linked to care, treatment, and partner services.

Routinely evaluate, and if needed, link perinatal deaths and serologic data to ascertain possible congenital syphilis cases.

Activity 2.4: Use and disseminate data to drive public health action

Develop an annual publication of HIV, VH, STD, and TB activities and data that includes a summary per disease.

Use the National Tuberculosis Indicators Project (NTIP) to submit the “Indicator Summary” report annually and describe barriers to meeting National Performance Targets.

Disseminate programmatic findings to key stakeholders, including medical providers, government officials, and other collaborative partners.

Activity 2.5: Implement the current NCHHSTP Data Security and Confidentiality Guidelines

Develop policies and procedures for security and confidentiality and ensure yearly reviews to keep them current.

Provide yearly staff training on security and confidentiality and upon onboarding new staff.

Ensure all staff complete the security and confidentiality agreement annually.

Submit the Certification of Implementation of the NCHHSTP Data Security and Confidentiality Standards and Designation of Overall Responsible Party (ORP) statement annually and provide updated information as needed.

Use the USAPI Integrated Site Visit Review Guide to prepare for a site visit. Template will be shared with recipients post award.

Strategy 3: Workforce Development

Activity 3.1: Designate a TB Education and Training Focal Point who will become a member (if not already) of the TB Education and Training Network (TB ETN). This focal point will be responsible for the following activities:

Serve as primary contact in their respective TB program for CDC and TB Centers of Excellence (TB COEs) education and training activities, including needs assessments, capacity building, and resource development/sharing.

Ensure development and implementation of annual training and Human Resource Development (HRD) activities specific to their TB program.

Attend the biennial focal point meeting and the biennial TB ETN conference.

Identify training and HRD needs.

Coordinate competency-based in-service TB training and human resource development.

Establish evaluation strategies to improve existing trainings and to identify ongoing training and HRD needs.

Improve patient education and communications capacity within the program.

Coordinate trainings related to TB control with training for other disease control programs, such as HIV, viral hepatitis, and STDs.

Target TB trainings to other health care providers or organizations serving high-risk populations.

Provide an update on HRD activities year-to-date and HRD plans for the upcoming budget period in the annual performance report.

Activity 3.2: Build public healthcare workforce capacity

Develop or update individual training plans for programmatic, surveillance, and laboratory staff.

Develop and deliver local in-service trainings related to programmatic, surveillance, and laboratory. The target audiences may include internal and external partners. Base content on existing training resources or develop in collaboration with partners (e.g., HIV Capacity Building Assistance Provider Network, National Network of STD Clinical Prevention Training Centers, and TB Centers of Excellence). The following describes the types of trainings to be developed or delivered including existing training resources where available.

o HIV: Cover HIV testing algorithms, including use of rapid and point-of-care testing.

o VH: Cover HBV testing algorithm, case definitions, data quality assurance, HBsAg data collection and reporting by using a CDC-approved data system.

o STD: Cover Partner Services for program and medical staff, using the following resources:

DIS Fundamentals Training Plan (https://www.train.org/cdctrain/training_plan/4401) Online continuing education resources for program and medical providers. https://www.cdc.gov/std/training/onlinetraining.htm and https://californiaptc.com/ Trainings and technical assistance for disease intervention specialists (DIS) and other partner services providers including medical providers and online training for continuing education.

o TB: Incorporate materials from the following resources:

https://www.cdc.gov/tb/education/professional-resources.htm https://www.cdc.gov/tb/education/professionaltools.htm https://www.cdc.gov/tb/education/provider_edmaterials.htm o LAB: Implement and document annual training and competency assessment for laboratory technicians, including safety training and shipping of infectious and diagnostic specimens per International Air Transportation Association (IATA) standards as well as basic and test-specific laboratory procedures.

Activity 3.3: Participate in CDC-sponsored conferences and meetings

PS23-2302 PCSI NOFO Meetings National HIV Prevention Conference and National HIV Surveillance Conference National STD Prevention Conference National TB Conference (NTC) TB Education and Training Network/Program Evaluation Network (TB PEN/ETN) Conference Pacific Islands TB Controllers Association (PITCA) Conference ORP and PCSI Leadership (i.e., PCSI Lead, PCSI Surveillance Coordinator, and PCSI Laboratory Coordinator) should attend pandemic mitigation and control related trainings as available and needed

Activity 3.4: Develop and/or update policies and procedures to support program implementation across PCSI programs

Develop and/or update policies and procedures to ensure PCSI staff are adequately trained to implement programmatic activities. Policies and procedures may include those needed to conduct service delivery, reporting of data, etc.

Ensure policies and procedures are provided to PCSI staff.

Strategy 4: Laboratory Strengthening

To support the implementation of Strategy 4, recipients should identify a PCSI Laboratory Coordinator at a minimum of 25% of time. Roles and responsibilities include:

Ensure the availability of high-quality public health laboratory services and sufficient supplies within expiration date to perform testing.

Attend PCSI Steering Committee meetings.

Provide quarterly updates on inventory of supplies and reagents and status of laboratory instruments (functionality and maintenance) to the PCSI Steering Committee, individual program leads, and CDC, on request.

Activity 4.1: Deliver reliable, accurate, and timely public health laboratory services and ensure strong laboratory quality management systems.

Ensure strong inventory control system whereby test kits within expiration date are available as well as ordered with sufficient lead time with consideration of procurement timeframes.

Develop standard operating procedures (SOPs) for proper specimen(s) collection, handling, transport, storage, processing, testing, and results reporting for HIV, VH, STD, and TB testing. SOPs should be reviewed at least annually and updated as needed.

o For STD testing, ensure quality of syphilis testing through resources such as: https://www.who.int/reproductivehealth/congenital-syphilis/spt-program/en/ o https://www.who.int/reproductivehealth/congenital-syphilis/spt-program-working/en/

Report results from molecular testing (e.g., GeneXpert Chlamydia trachomatis / Neisseria gonorrhoeae) within 48 hours of specimen receipt in the laboratory.

o For TB testing, use recommended acid-fast bacilli (AFB) staining methods for direct smear microscopy and report accurate and reliable results within 24 hours of specimen receipt in the laboratory. Use recommended nucleic acid amplification test (e.g., Xpert MTB/RIF) for direct detection of Mycobacterium tuberculosis and report results within 48 hours of specimen receipt in the laboratory.

Follow procedures to ensure referred specimens are stored, packaged, and shipped in a timely manner to the associated reference laboratory per IATA standards. Report local results as applicable.

Establish or maintain a laboratory quality assurance program including use of appropriate laboratory controls and participation in an external quality assurance program. Within the first year of funding, establish a baseline for the following:

o Inventory of hospitals and clinics or other settings where HBV tests are provided o Inventory of type of tests for HBV, hepatitis C virus (HCV) and hepatitis A virus

(HAV) (if available) ---point-of-care tests, type of point-of-care test (WHO PQ or any vendor) o Availability of facilities for VH testing—ELISA machines, qualified staff (identifying any training needs) o Inventory of laboratories where Hepatitis B serum is tested

Develop procedures to report Laboratory Testing Metrics to include information about numbers of tests performed and results. Metrics should also include review of results for referred specimens shipped to reference laboratories.

Participate on quarterly TB laboratory conference calls with the Pacific Island Health Officer’s Association (PIHOA) Regional Laboratory Coordinator, regional TB reference laboratory, and CDC.

Activity 4.2: Evaluate laboratory data/practices and address needed improvements

Develop and maintain an accurate and complete laboratory register (electronic or paper-based) that includes local and reference laboratory results.

Develop procedures to report notifiable diseases to the appropriate local public health program.

Develop procedures to collate and review quarterly laboratory statistics.

Develop procedures to annually assess progress towards meeting CDC recommended and laboratory specific turnaround times.

Develop procedures to maintain laboratory equipment to ensure accurate test results.

Evaluate inventory control procedures to ensure system is efficient and effective in ensuring an adequate supply of all necessary test reagents. The system should monitor supplies and anticipate (forecast) the need to order recommended laboratory testing reagents and kits for HIV, HBV, STD, and TB

Strategy 5: Disease-Specific Prevention and Care

Activity 5.1: Conduct or facilitate high impact prevention including: prevention, screening, testing, linkage to care, treatment, and case management

HIV Prevention

Implement and/or coordinate targeted HIV testing in non-healthcare settings to identify undiagnosed HIV infection using a point-of-care HIV test (i.e., results available within 30 minutes) on the following populations disproportionately affected by HIV: men who have sex with men (MSM), persons who inject drugs (PWID), transgender women, and commercial sex workers.

o In non-healthcare settings, at least 70% of point-of-care tests should be used among disproportionately affected populations

Use a second rapid HIV test (i.e., results available within 30 minutes) to confirm a preliminary positive HIV test result as promoted in the following: HIV Testing in Nonclinical Settings | HIV Testing | HIV/AIDS | CDC Distribute condoms for persons disproportionately affected by HIV and STDs, including persons with HIV (PWH).

Provide linkage to medical care, treatment, and prevention services for PWH.

Link persons with newly diagnosed HIV infection to medical care within 30 days of diagnosis.

Support retention in medical care, treatment, and prevention services for PWH.

Provide guidance on the importance of early HIV screening for all pregnant persons, according to current CDC recommendations.

o Note: Other funding sources should be leveraged to implement HIV screening among pregnant persons. PS23-2302 funds should be used as payer of last resort to conduct HIV screening among pregnant persons. Additionally, given the low burden of disease among pregnant persons in this region in clinical settings, a cap of 10% of HIV funding can be used to test this population.

Develop a plan to implement point-of-care testing in non-healthcare settings.

Utilize the CDC/HRSA integration of prevention and care plan to facilitate prevention, treatment, case management, and linkage to care for newly diagnosed HIV positive individuals and PWH.

Educate medical providers on the use of pre-exposure prophylaxis (PrEP) an HIV prevention strategy.

VH

Work with partners (e.g., MCH/ANC, Immunization Programs, Community Health Center, private hospitals, DISs) to screen pregnant persons for VH.

Ensure the HbsAg status for all pregnant persons is recorded and provided to the hospital or birthing facility where the delivery is planned and to the health provider who will care for the infant (prophylaxis (HepB vaccine and HBIG) within 12 hours of birth for all infants born to HbsAg-positive women).

Provide HBV test kits to hospitals and other venues reaching populations disproportionately affected by HBV.

Work with immunization programs to support an increase in HBV vaccination coverage for infants, children and adolescents, susceptible adults at risk for HBV (household contacts, sexual partners, IDU, MSM, occupational, others).

Implement and/or promote HBV testing and screening among pregnant persons, and others included in the Target Populations section as resources allow, according to the Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021-2025 and CDC Prevention of Hepatitis B Virus Infection in the United States:

Recommendations of the Advisory Committee on Immunization Practices (2018), including Screening All Pregnant Women for Hepatitis B Virus (HBV) Infection. As well as the Global Health Sector Strategy on Viral Hepatitis 2016-2021 (To be updated to the Global Health Sector Strategies on HIV, Viral Hepatitis and Sexually Transmitted Infections 2022-2030), and WHO Interim Guidance for Country Validation of Viral Hepatitis Elimination.

Conduct a needs assessment for viral hepatitis including o An inventory of hospitals, clinics or other settings where HBV testing can be conducted o An inventory of type of tests for HBV and HAV (if available) ---POC tests, type of POC test (WHO PQ or any vendor) o An estimate the number of tests needed/year o An assessment of the availability of facilities for VH testing—ELISA machines, qualified staff (need for training) o An inventory of laboratories where Hepatitis B serum tested

Identify at least two high-volume clinics to expand hepatitis B testing

STD

Promote and monitor the extent to which pregnant persons receive recommended prenatal screening for chlamydia, gonorrhea, and syphilis within the first trimester.

Monitor the extent to which pregnant persons receive recommended treatment for chlamydia, gonorrhea, and syphilis.

Conduct annual testing for sexually active females younger than age 25 years for chlamydia and gonorrhea using a CDC recommended testing technology.

Identify internal and external partners and venues to increase chlamydia, gonorrhea, and syphilis screening rates among priority and vulnerable populations (see Target Populations section).

o Venues include family planning, women clinics, adolescent clinics, or other facilities providing reproductive healthcare, and schools/colleges.

Develop/ enhance the data sharing system to ensure treatment of cases and their partners.

Monitor extent to which clients with chlamydia, gonorrhea, and syphilis are appropriately managed according to CDC Sexually Transmitted Infections Treatment Guidelines, 2021:

https://www.cdc.gov/std/treatment-guidelines/default.htm Manage, monitor, and document the number of women with a positive test for chlamydia, gonorrhea, and/or syphilis whose partners are treated.

To eliminate congenital syphilis, manage, monitor, and document the number of pregnant persons with a positive syphilis test.

TB – Diagnosis and treatment of persons with suspected or confirmed TB disease

Implement the TB case management approach to coordinate the necessary medical, nursing, outreach, and social services needed to ensure all persons with suspected or confirmed TB disease complete an appropriate and effective course of treatment.

o Assign a specific worker (i.e., a case manager) who will be primarily responsible for each person with suspected or confirmed TB disease.

o All reported persons with suspected or confirmed TB disease should be assigned to a case manager, regardless of whether medical care is provided by a health department/ministry of health TB clinic or a private provider.

o The case manager will be responsible for ensuring that patients adhere to treatment, comply with medical visits, and complete treatment.

o Case managers are also responsible for ensuring contacts are identified, evaluated, and complete treatment for LTBI, if appropriate.

Ensure adherence to TB treatment by using in-person directly observed therapy (DOT), electronic directly observed therapy (eDOT), incentives, enablers, and/or outreach staff who are culturally competent.

Assess adequacy and appropriateness of therapy for each patient by reviewing initial regimen, susceptibility results, adherence, and response to therapy. Therapy should be consistent with American Thoracic Society/ Infectious Disease Society of America/Centers for Disease Control and Prevention guidelines. Refer to the following web link for more information: http://www.cdc.gov/tb/topic/treatment/default.htm.

Seek expert consultation for treatment of multidrug-resistant (MDR TB) and other complex cases from TB experts who are up to date on current evidence-based practices and guidelines, and who are readily available to provide timely documented advice and ongoing medical guidance. The TB COEs for Training, Education, and Medical Consultation services should be readily used as needed, and relationships should be fostered between any local TB experts who provides the program with clinical guidance and the funded jurisdictions' regional COE. Healthcare providers of record for patients with TB disease should be expected to be familiar with laboratory and chest imaging results as well as current medications and comorbidities when seeking additional medical consultation services.

Seek expert consultation regarding laboratory results for molecular detection of drug resistance or interpretation of other laboratory results when needed. Refer to the following web links for more information:

http://www.cdc.gov/tb/topic/laboratory/default.htm.

Collaborate with partners at local jails, correctional facilities, homeless shelters, and substance abuse settings to ensure that all newly diagnosed TB cases are treated to completion.

Partner with CDC Division of Global Migration and Quarantine (DGMQ) to support international TB quarantine efforts.

Conduct monthly case conference meetings to systematically review the progress and treatment of persons with suspected or confirmed TB disease and develop plans to address any barriers to adherence.

o These meetings should include staff who are involved in the care and management of TB patients including, case managers, DOT workers, contact investigation staff, nurses, and clinicians o The case manager presents information about the status of each TB patient under medical care and the progress of the contact investigation.

o Each TB patient is presented once within 30 days of starting the intensive phase of treatment and again within 30 days of starting the continuation phase of treatment.

TB – Examination of Immigrants and Refugees with TB or LTBI (if applicable)

Ensure that immigrants and refugees classified as A, B1, or B2 are located promptly and examined and treated appropriately: http://www.cdc.gov/immigrantrefugeehealth/ Report examination results of domestic TB follow-up activities including treatment outcomes for TB and LTBI to the Electronic Disease Notification (EDN) system:

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6207a1.htm

TB – Targeted Testing and Treatment of LTBI

Within the first three months of the NOFO, identify a local population for targeted TB testing and treatment using epidemiological data. The selected local population must be at increased risk for LTBI or developing TB disease once infected with M. tuberculosis and may include, but are not limited to, persons with diabetes, end-stage renal disease, persons experiencing homelessness, have substance use disorders, or who are incarcerated.

Within the first year of the NOFO, establish a baseline for seeking and evaluating persons from the target population and identify a goal and strategy for increasing targeted testing for LTBI.

Within the first year of the NOFO, establish a baseline for initiating and completing treatment for persons diagnosed with LTBI who are recommended for treatment and identify a goal and strategy for increasing LTBI treatment initiation and completion rates.

Establish or build on existing partnerships with non-communicable disease programs, primary care providers, community health centers, or other partners to expand LTBI testing and treatment.

Report targeted testing and treatment data using the Aggregate Reports for Tuberculosis Program Evaluation (ARPE): Targeted Testing and Treatment of Patients with Latent TB Infection form.

Refer to the following web links for more information:

o https://www.cdc.gov/tb/publications/ltbi/ltbiresources.htm o https://theunion.org/technical-publications/management-of-diabetes-mellitus-tuberculosis-a-guide-to-the-essential-practice o http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945809/

Activity 5.2: Provide partner services and contact investigation

HIV

Provide ongoing partner services for all persons with newly diagnosed infection, those with previously diagnosed infection, and their partners following the Recommendations for Partner Services Programs for HIV Infection, Syphilis, Gonorrhea, and Chlamydial Infection, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5709a1.htm Collaborate and coordinate with STD surveillance programs to use data to maximize the number of persons identified as candidates for Partner Services.

Partner with non-health department providers, including non-governmental organizations (NGOs) and private medical treatment providers, to identify more opportunities to provide Partner Services.

VH

Follow up with household contacts and sex partners of persons with hepatitis B.

o Asking about vaccination history and testing as needed.

o If previously unvaccinated and susceptible, then provide hep B vaccines.

STD

Provide partner services for sex contacts of persons diagnosed with syphilis, gonorrhea, and/or chlamydia within 14 days of diagnosis and link or provide treatment for those diagnosed.

Use the following resources:

o Recommendations for Partner Services Programs for HIV Infection, Syphilis, Gonorrhea, and Chlamydial Infection, 2008.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5709a1.htm Program Operations Guidelines for STD Prevention-Partner Services link:

https://www.cdc.gov/std/program/partners.pdf

Additional support services for sex contacts, including contraception for women HHS, Office of Population Affairs link: https://opa.hhs.gov/reproductive-health?pregnancyprevention/%20index.html

TB

Ensure that contact investigation activities are initiated and completed promptly;

including interviewing TB cases or utilizing location-based methods to identify contacts and ensuring that infected contacts begin and complete an appropriate diagnostic evaluation to exclude TB disease and a course of treatment for LTBI if recommended after TB disease has been excluded.

Assess reasons for…