oppCDC-RFA-PS19-1901-cfda93.977-cidCDC-RFA-PS19-1901-instructions.pdf

Centers for Disease Control

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention

Strengthening STD Prevention and Control for Health Departments (STD PCHD)

CDC-RFA-PS19-1901

Application Due Date: 07/31/2018

Strengthening STD Prevention and Control for Health Departments (STD PCHD)

CDC-RFA-PS19-1901

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text 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 Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS19-1901. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Strengthening STD Prevention and Control for Health Departments (STD PCHD) 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 - Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS19-1901

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.977 F. Dates:

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

2. Due Date for Applications: 07/31/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Two identical webinars will be held to provide information about this NOFO. Dates, times, and registration links are as follows:

May 11 from 3:00PM-4:30PM Eastern Time. Registration Link https://cc.readytalk.com/r/d77aiqy2bpzk&eom May 15 from 2:00PM-3:30PM Eastern Time. Registration Link https://cc.readytalk.com/r/vx2z34ciwn59&eom

G. Executive Summary:

1. Summary Paragraph:

CDC announces the availability of fiscal year 2019 funds for a cooperative agreement for health departments to implement and strengthen STD prevention and control programs. The purpose of this NOFO is to prevent and control three major STDs: chlamydia, gonorrhea, and syphilis. This NOFO supports strategies and activities to: eliminate congenital syphilis; prevent antibiotic resistant gonorrhea; reduce primary and secondary syphilis; prevent STD-related pelvic https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov inflammatory disease, ectopic pregnancy, and infertility; address STD-related outbreaks; and reduce STD-related health disparities. Priority populations for this NOFO include adolescents and young adults, men who have sex with men, and pregnant women.

Priority strategies and activities include: conduct STD surveillance; respond to STD-related outbreaks; identify persons with STDs and link them and their partners to care and to treatment through targeted disease investigation and intervention; promote CDC-recommended screening, diagnosis, and treatment practices among relevant providers; disseminate local data and information to the health care community and general public; monitor and develop STD-related policy; develop and strengthen multi- sector partnerships to support STD prevention and control; support HIV prevention goals and collaborate with health department HIV programs;

and analyze and use data for increased program insights and program improvement.

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 59

d. Total Period of Performance Funding: $475,000,000

e. Average One Year Award Amount: $0 Refer to Funding Tables on the PS19-1901 website (https://www.cdc.gov/std/funding/pchd/default.htm) for eligible applicants' award information.

Awards will be allocated using a funding algorithm that is based on 2012-2016 morbidity data for chlamydia, gonorrhea, and syphilis as well as project area population size. The funding strategy includes a minimum funding base of $300,000 to support organizational infrastructure and a sufficient multi-disciplinary workforce for the program. Funding amounts are subject to the availability of funds.

f. Total Period of Performance Length: 5

g. Estimated Award Date: 01/01/2019

h. Cost Sharing and / or Matching Requirements: N Although no statutory matching requirement for this NOFO exists, leveraging other resources and related, ongoing efforts to promote sustainability is strongly advised.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview CDC estimates that approximately 20 million new, viral and bacterial sexually transmitted infections occur each year and that almost half of them are among young people ages 15 to 24 [1]. Three curable bacterial sexually transmitted diseases (STDs): chlamydia (CT), gonorrhea https://www.cdc.gov/std/funding/pchd/default.htm

(GC), and syphilis are nationally reportable and are the focus of federally funded STD prevention programs throughout the United States (U.S.). In 2016, increases in all three were observed: nearly 1.6 million cases of chlamydia, over 460,000 cases of gonorrhea, and nearly 28,000 cases of primary and secondary syphilis were reported to CDC. For syphilis, this represented a 16.5% increase from 2015 and a 77.5% increase from 2012 [2]. Reported cases of congenital syphilis increased by 88% during 2012- 2016 [2]. Often, these diseases are asymptomatic. Patients unaware of their infection may face serious, long-term consequences;

for example, untreated CT and GC increase a woman's risk for pelvic inflammatory disease (PID) and infertility. Untreated early syphilis in pregnant women can lead to infection of the fetus in 80% of cases and can result in adverse pregnancy outcomes. Untreated bacterial STDs can facilitate the sexual transmission of HIV.

These three bacterial STDs have effective testing and treatment modalities that make it possible to avoid costly long-term consequences. However, Neisseria gonorrhoeae, the causative bacterium of GC, has rapidly acquired resistance to all but one of the antimicrobials that have been used for treatment, raising concerns about the threat of untreatable GC. In addition to the physical and psychological consequences of STDs, these diseases exact a significant economic toll; direct medical costs associated with chlamydia, gonorrhea, and syphilis are approximately $857.2 million dollars annually [3].

Health departments play a critical role in addressing STD prevention and control and are well-positioned to monitor and understand local trends in STDs through case-based surveillance, and to respond to emerging threats and outbreaks. Health department STD programs also have the authority and skills to conduct disease investigation activities including partner services, an effective intervention to prevent STD transmission in some populations [4]. Given that most STDs are diagnosed outside of public STD clinics, health departments must also work with primary care and other health care providers and organizations to promote the delivery of recommended, evidence-based STD screening, timely treatment, and other prevention services [5].

STD prevention and control in the public health sector is guided by the public health functions of assessment, assurance, and policy development [6]. Assessment is defined as determining community strengths and identifying current and emerging threats to the community's health through regular and systematic surveillance and review of risk factors and health indicators with public health and health care system partners. Assurance moves beyond measuring and understanding the activity or problem to actively taking steps to improve the activity or to reduce or solve the problem. Policy development is defined as working with partners to promote and protect the health of the community through formal and informal policies, program guidelines, and environmental changes.

Through this new funding cycle, CDC seeks to strengthen STD prevention and control for health departments.

b. Statutory Authorities Section 318(a) - (c) of the Public Health Service Act [42 U.S.C. Section 247c (a) - (c)], as amended.

c. Healthy People 2020

This NOFO addresses the Healthy People 2020 focus area of Sexually Transmitted Diseases:

https://www.healthypeople.gov/2020/topics-objectives/topic/sexually-transmitted-diseases It also addresses: Access to Quality Health Services; Cancer; HIV Infection; Immunization and Infectious Diseases; Maternal, Infant and Child Health; and Public Health Infrastructure.

d. Other National Public Health Priorities and Strategies CDC's Call to Action: Let's Work Together to Stem the Tide of Rising Syphilis in the United States https://www.cdc.gov/std/syphilis/syphiliscalltoactionapril2017.pdf National Strategy for Combating Antibiotic-Resistant Bacteria https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf CDC National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf National HIV/AIDS Strategy https://www.hiv.gov/federal-response/national-hiv-aids-strategy/overview National Stakeholder Strategy for Addressing Health Equity https://minorityhealth.hhs.gov/npa/Default.aspx CDC - The Public Health System and the 10 Essential Public Health Services https//www.cdc.gov/stltpublichealth/publichealthservices/essentialhealthservices.html CDC Winnable Battles http://www.cdc.gov/WinnableBattles/index.html

e. Relevant Work This NOFO builds upon previous and current STD surveillance and prevention programs for health departments and community-based partners, including:

PS13-1301: Accelerating the Prevention and Control of HIV/AIDS, Viral Hepatitis, STDs and TB in the U.S.-Affiliated Pacific Islands. PS18-1801: Accelerating the Prevention and Control of HIV, Viral Hepatitis, STDs and TB in the U.S.-Affiliated Pacific Islands (2018-2022) https ://www.cdc.gov/nchhstp/funding/announcements/ps18-1801/index.html PS13-1306: STD Surveillance Network (SSuN) https://www.cdc.gov/std/ssun/default.htm PS13-1309: National Network to Enhance Capacity of State and Local Sexually Transmitted Disease Prevention Programs (NNECS). PS18-1808: National Network to Enhance Capacity of State and Local Sexually Transmitted Disease Prevention Programs.

PS14-1402: Improving Sexually Transmitted Disease Programs through Assessment, Assurance , Policy Development, and Prevention Strategies (STD AAPPS) PS14-1407: National Network of Sexually Transmitted Diseases Clinical Prevention Training https://www.healthypeople.gov/2020/topics-objectives/topic/sexually-transmitted-diseases https://www.cdc.gov/std/syphilis/syphiliscalltoactionapril2017.pdf https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.hiv.gov/federal-response/national-hiv-aids-strategy/overview https://minorityhealth.hhs.gov/npa/Default.aspx https://www.cdc.gov/stltpublichealth/publichealthservices/essentialhealthservices.html http://www.cdc.gov/WinnableBattles/index.html https://www.cdc.gov/nchhstp/funding/announcements/ps18-1801/index.html https://www.cdc.gov/nchhstp/funding/announcements/ps18-1801/index.html https://www.cdc.gov/std/ssun/default.htm https://www.cdc.gov/std/foa/aapps/default.htm https://www.cdc.gov/std/foa/aapps/default.htm https://www.grants.gov/web/grants/view-opportunity.html?oppId=250755

Centers (NNPTC) PS14-1408: STD/HIV Disease Intervention Services Training Center (DISTC) PS14-1415: Economic Modeling for HIV, Viral Hepatitis, STD, TB, and School Health PS15-1504: Tuskegee University Apology Commemoration Activities (Tuskegee) PS15-1511: Evaluation of STD Programs Deploying DIS to Improve HIV Outcomes PS17-0002: Understanding the Epidemiology of Syphilis in the United States PS17-1707 - Community Approaches to Reducing STDs https://www.cdc.gov/std/health-dispa rities/cars.htm PS17-1708 - Enhancing National STD/HIV Prevention Efforts by Promoting Holistic, Comprehensive, and Evidence-Informed Health and Wellness Approaches through Strategic Partnerships DIS Certification Project: www.phaboard.org/dis-certification/ Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement https://www.cdc.gov/ncezid/dpei/epidemiology-laboratory-capacity.html Gonococcal Isolate Surveillance Project (GISP): https://www.cdc.gov/std/gisp/default.htm Strengthening the United States Response to Resistant Gonorrhea (SURRG): https://www.cdc .gov/std/gonorrhea/arg/carb.htm

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategy Areas Short-term outcomes Intermediate outcomes Long-term outcomes

Conduct surveillance

Improved completion and timeliness of data on reportable STDs

Increased targeting of high impact STD prevention and care resources and activities

Increased effectiveness, efficiency, and impact of STD prevention

Conduct disease investigation and intervention

Faster response to STD transmission increases and outbreaks by STD programs Increased treatment of cases and their partners Increased identification of persons living with

HIV

Reduced outbreak-related STD transmission Increased use of STD, HIV, and other services by cases and partners Increased offering of EPT by providers Increased use of EPT by partners

Reduced STD transmission and related adverse health outcomes Reduced STD-related HIV transmission https://www.grants.gov/web/grants/view-opportunity.html?oppId=250755 https://www.grants.gov/view-opportunity.html?oppId=246313 https://www.cdc.gov/std/foa/aapps/dis-hiv.htm https://www.cdc.gov/std/health-disparities/cars.htm https://www.cdc.gov/std/health-disparities/cars.htm http://www.phaboard.org/dis-certification/ https://www.cdc.gov/ncezid/dpei/epidemiology-laboratory-capacity.html https://www.cdc.gov/std/gisp/default.htm https://www.cdc.gov/std/gonorrhea/arg/carb.htm https://www.cdc.gov/std/gonorrhea/arg/carb.htm

Increased knowledge and skills to offer expedited partner therapy (EPT) by targeted providers

Promote CDC-recommended screening, diagnosis, and treatment and skill to use recommended screening, diagnosis, and treatment practices by targeted providers

Increased screening for STDs Increased diagnosis of STDs Increased use of recommended, timely treatment Increased identification of persons living with

HIV

Reduced STD transmission and related adverse health outcomes Reduced risk of gonorrhea antibiotic resistance Reduced STD-related HIV transmission

Promote STD prevention and policy of STDs and STD services by public and provider community Stronger STD program role in policy discussions

Increased use of STD services by public Improved STD clinical and reporting practices Improved health department policies for STD prevention

Reduced STD transmission and related adverse health outcomes

Analyze and use data for program improvement

More efficient targeting of STD prevention and care resources and services by STD programs

Increased effectiveness of high impact STD prevention and control activities

Increased effectiveness, efficiency, and impact of STD prevention

i. Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to prevent and control three major STDs: chlamydia, gonorrhea and syphilis. This NOFO supports strategies and activities to: eliminate congenital syphilis; prevent antibiotic resistant gonorrhea; reduce primary and secondary syphilis; prevent STD-related pelvic inflammatory disease, ectopic pregnancy, and infertility; address STD-related outbreaks; and reduce STD-related health disparities. Priority populations for this NOFO include adolescents and young adults, men who have sex with men, and pregnant women.

ii. Outcomes The program is expected to demonstrate measurable progress toward addressing the short-term and medium-term outcomes that appear in bold in the NOFO logic model. Proposed indicators for these outcomes are described in the section entitled CDC Evaluation and Performance Measurement Strategy. That section also describes outputs that will be measured as part of the performance monitoring strategy. Expected outcomes, per strategy area, include:

Conduct surveillance

Improved completion and timeliness of data on reportable STDs

Conduct disease investigation and intervention

Increased treatment of cases and their partners Increased identification of persons living with HIV

Promote CDC-recommended screening, diagnosis, and treatment

Increased screening for STDs Increased use of recommended, timely treatment Increased identification of persons living with HIV

Promote STD prevention and policy

Improved health department policies for STD prevention

Analyze and use data for program improvement

More efficient targeting of STD prevention and care resources and services by STD programs

iii. Strategies and Activities Overview All applicants are required to implement a program of core STD prevention and control strategies and activities across the public health functions of assessment, assurance, and policy development. The strategies are organized into five Strategy Areas: 1) Conduct surveillance, 2) Conduct disease investigation and intervention, 3) Promote CDC-recommended screening, diagnosis, and treatment, 4) Promote STD prevention and policy, and 5) Analyze and use data for program improvement. While assessment, assurance and policy development are guiding principles of core public health functions, not all activities described below fall neatly under each core function.

Priority strategies and activities in the assessment domain are to conduct case-based surveillance of chlamydia, gonorrhea, and syphilis, including congenital syphilis and other adverse outcomes, and to identify outbreaks and trends in STD epidemiology. Priority strategies and activities in the assurance domain are to implement disease investigation and intervention activities such as outbreak response, targeted partner services, including expedited partner therapy (EPT), and to promote recommended STD screening, diagnosis, and treatment practices to relevant providers. The priorities in the policy development domain are to develop and strengthen partnerships among communities, providers, and organizations to increase awareness and knowledge of the complexities of STD issues, and to develop and monitor policies aimed at improving access to and quality of STD prevention services. Data analysis, utilization and program improvement represent other priority activities that support assessment, assurance, and policy development.

Cross cutting strategies: Partnerships and STD-related HIV prevention Partnerships represent an important cross-cutting aspect of comprehensive, effective STD prevention and control. Action-oriented and strategic partnerships are essential to implementing the strategies and activities below and meeting the goals of this NOFO. CDC encourages applicants to collaborate with partners across the public health, health care, academic, and community-based sectors in their project areas.

For example, partnerships with HIV and maternal-child health (MCH) surveillance counterparts may strengthen surveillance activities, such as the collection of more robust data related to HIV serostatus and pregnancy status. Partnerships with agencies serving women who are pregnant, such as MCH programs, with community-based organizations serving MSM, and with pharmacies where EPT can be dispensed, may strengthen disease intervention, screening, and treatment work. To promote recommended STD screening and treatment practices, health departments also should seek partnerships with clinical providers and health care organizations such as federally qualified health centers, school-based health centers, correctional facilities, Medicaid programs, large health plans and professional medical and nursing organizations. In addition, academic partnerships are critical for supporting innovative interventions and robust evaluation work. Health departments are encouraged to develop and sustain broad and innovative partnerships to ensure high quality STD prevention services to the communities they serve.

Given overlapping epidemics, key populations, and intervention strategies, STD programs are inherently involved in high impact HIV prevention, just as HIV programs are involved in STD prevention. CDC expects all applicants to support the HIV prevention goals in their project areas and collaborate with HIV programs. STD-related HIV prevention activities should be conducted under this cooperative agreement but they should not exceed ten percent (10%) of program effort and allocation.

STD surveillance activities should involve accessing and using HIV data to characterize co-infection and identify STD cases for potential priority follow-up for partner services, HIV testing, linkage to (or re-engagement in) HIV care or PrEP for both men and women. In the course of disease investigation and intervention, HIV-related actions such as HIV testing, linkage to (or re-engagement in) HIV care, and linkage to PrEP should be integrated into STD program protocols, as appropriate to each project area. The promotion of quality STD care should also support quality recommended HIV prevention and care, particularly in STD specialty care settings.

In the strategies and activities below, CDC does not explicitly describe all relevant STD-related HIV prevention activities or partnerships that relate to each section, as they can be specific to each program. This is not an indication that these activities are secondary in any way.

Required strategies and activities

Implementation of all strategies and activities described below is required by all applicants.

Applicants can request to opt out of selected required activities by providing a strong justification, which must be based on program priorities, resources, and/or policies. Approval will be considered after review of the application. Applicants are encouraged to implement additional innovative activities and to conduct additional evaluation, if resources are available.

Approximate funding allocation for each strategy area is listed below. This is intended to be a guide for applicants in planning their program and budget. In general, applicants should view surveillance as highest priority, meriting higher program effort and resource allocation, because this strategy area is paramount to the success of all other strategy areas. The strategy areas related to disease investigation and intervention and related to screening, diagnosis, and treatment are the next highest priority areas, each meriting roughly equal program effort and resource allocation. Following those are the strategy areas related to the promotion of STD prevention and policy and related to data utilization and program improvement. The specific distribution of effort across these areas will vary by applicant, and consultation with CDC about this is strongly encouraged.

Resources awarded through this NOFO are intended to be used for the strategies and activities described below. However, state and local public health agencies across the United States each have specific STD public health priorities based on epidemiological and program data due to geography, specific local populations and subpopulations, organizational capacity, and the diverse challenges they face. Often, there are unanticipated events during the period of performance that may require the diversion of resources to a specific emerging or re-emerging disease. In order to better meet each project area's specific needs and lessen the delays in responsiveness during unanticipated events, resources need to be used in a flexible way so that agencies may be able to better address planned-for and unanticipated STD-related public health threats.

Strategy Area I: Conduct Surveillance For the purposes of this NOFO, surveillance is defined as the systematic collection, management, analysis, interpretation, and dissemination of data. Programs should continually seek to improve the timeliness and quality of surveillance data of STD cases and adverse outcomes. Surveillance data are used to characterize trends in and factors associated with STD infection and STD-related adverse outcomes, guide outbreak detection and response, inform public health interventions, improve resource allocation, and evaluate public health response.

Regularly monitoring and reporting on the burden of STDs across locally-relevant at-risk population groupings and geographic sub-divisions also helps establish the business case for STD prevention activities.

Because the systematic collection of data may take different forms for different diseases, the data collection for each disease is described in separate strategies below. The number of variables for each strategy, as listed below, may be modified to include additional variables during the period of performance. Data processing, management, and quality assurance are fundamental to the success of STD surveillance activities; and though these aspects of surveillance are not specifically described as separate activities, programs should continue to maximize their capacity to manage, validate, evaluate, and report case-based and other relevant data in a timely manner.

As the field of informatics advances, it is important for STD programs to adopt efficient technologies and to improve methods of collecting and managing data, while ensuring security, confidentiality, and accuracy of the information. To this end, programs should increase their capacity to receive and efficiently process, de-duplicate and automatically import electronic records (such as those from electronic laboratory reporting (ELR) and from electronic health records (EHR)) into their surveillance data management systems. Programs should strengthen efforts to increase the proportion of laboratories and providers reporting STD- specific results electronically, and should work with their health departments' communicable disease programs to build interoperable or integrated disease reporting and surveillance systems. Programs should implement HL7 messaging for submission of case notifications to CDC, and should implement robust, automated procedures for real-time matching of STD case records with the HIV case registry (eHARS). Systematic de-duplication of cases and quality control of laboratory and provider-based case data must be improved, including the ability to monitor STDs among unique persons over time by implementing and maintaining unique, static person-identifiers through the creation of a master person index.

This NOFO may fund health information systems infrastructure, including workforce and public health laboratories, to support the specific strategies, activities, and outcomes described in this NOFO. Any proposed health information system infrastructure activities should be reflected in the detailed budget submitted by grant applicants.

Surveillance should be allocated approximately 25-35% of program effort under this NOFO.

1. Conduct Chlamydia (CT) surveillance

a) Collect, manage, analyze, interpret and disseminate data on identified cases of chlamydia, ensuring timely capture of core epidemiologic variables available on laboratory reports: age, sex, county, diagnosing facility type, specimen collection date, and anatomic site(s) of infection

2. Conduct Gonorrhea (GC) surveillance

a) Collect, manage, analyze, interpret and disseminate data on identified cases of gonorrhea, ensuring timely capture of core epidemiologic variables available on laboratory reports: age, sex, county, diagnosing facility type, specimen collection date, and anatomic site(s) of infection

b) To better understand GC epidemiology, conduct provider follow-up and, if needed, brief patient interviews of a random sample of GC cases from a well-defined high morbidity area or the project area as a whole. Ensure timely and quality capture of core epidemiologic variables including, but not limited to: age, sex, county, diagnosing facility type, specimen collection date, anatomic site(s) of infection, race/ethnicity, gender identity/sexual orientation, sex of sex partner(s), clinical signs/symptoms, pregnancy status, HIV status, partner treatment (i.e., EPT provision), gonorrhea-related sequelae (i.e., presence of pelvic inflammatory disease (PID), disseminated gonococcal infection (DGI), etc.), substance use, date of diagnosis, treatment received (including names and doses of treatment), date of treatment, co-infection with other STDs, and history of GC infection

3. Conduct syphilis surveillance

a) Collect, manage, analyze, interpret and disseminate data on identified cases of syphilis, ensuring timely capture of core epidemiologic variables available on laboratory reports:

age, sex, county, diagnosing facility type, and specimen collection date

b) To better understand primary and secondary (P&S) syphilis epidemiology, conduct provider follow-up and, if needed, brief patient interviews of all cases of P&S syphilis.

Ensure timely and quality capture of core epidemiologic variables including, but not limited to: age, sex, county, diagnosing facility type, specimen collection date, race/ethnicity, gender identity/sexual orientation, sex of sex partner(s), pregnancy status, clinical signs/symptoms, HIV status, substance use, treatment received, date of treatment, and history of syphilis

4. Conduct congenital syphilis (CS) surveillance

a) To better understand CS epidemiology, conduct provider and mother follow-up and review medical records of all reported CS cases. Based on information collected, manage, analyze, and disseminate data on reported cases of CS, ensuring timely and quality capture of epidemiologic core maternal, fetal, and neonatal variables including, but not limited to:

mother's age, race/ethnicity, county, stage of syphilis diagnosed during pregnancy, date(s) of 1st prenatal visit, syphilis testing (and corresponding titers), treatment(s) and delivery;

HIV status of mother, substance use, clinical settings of diagnosis and care; and fetal and neonatal information such as ultrasound findings, physical and laboratory findings, and HIV status of infant at birth

b) For applicants with 10 or more cases of congenital syphilis in the previous calendar year: Improve methods to match vital statistics birth and mortality data with syphilis surveillance data to review syphilis testing practices among women who delivered a stillborn baby, identify missed cases of syphilis-related stillbirth, and strengthen CS case report data

c) For applicants with 10 or more cases of congenital syphilis in the previous calendar year: Strengthen CS morbidity and mortality case review boards at the local and/or state level to help identify causes of CS and develop interventions to address causes

5. Conduct surveillance of adverse outcomes of STDs

a) Conduct active surveillance of adverse outcomes of adult syphilis including neurosyphilis and otic and ocular syphilis through sentinel approaches, collecting variables including, but not limited to: neurological manifestations, ocular manifestations, otic manifestations, and late clinical manifestations. These are in addition to the stage of syphilis and the core epidemiologic variables listed for P&S syphilis above

Strategy Area II: Conduct Disease Investigation and Intervention Another key strategy for the prevention of STDs is disease investigation and intervention, to rapidly identify individuals who are unknowingly infected and assure timely treatment, and in turn stop STD transmission and prevent adverse sequelae. Staff trained in disease investigation are critical to the STD workforce (usually Disease Investigation Specialists or DIS). (See http http://www.phaboard.org/dis-certification/

://www.phaboard.org/dis-certification/ for more information on the DIS Certification Project.)

Such work is urgent in outbreak situations. Disease investigation and intervention are needed to ensure rapid, coordinated detection and response to address, control, and prevent the spread of disease. Health departments have primary responsibility to detect STD outbreaks and respond to them in a timely and effective way. Since most outbreaks are unexpected by definition, it is essential that health departments develop and maintain high capacity to rapidly detect and respond to outbreaks or other significant changes in STD epidemiology.

Disease investigation and intervention should also occur in the course of ongoing STD transmission, through the health department or through the health care system. Health department investigation includes patient follow-up as well as partner services, whereby patients refer partners for treatment and refer other partners to health department staff (usually DIS) for assessment, linkage to care, and treatment. Through the health care system, partners of CT and/or GC patients can be reached through expedited partner therapy (EPT) (https://www .cdc.gov/std/ept/default.htm). EPT is the clinical practice of treating the sex partners of patients diagnosed with CT or GC by providing prescriptions or medications to the patient to take to his/her partner without the health care provider first examining the partner.

Disease investigation and intervention can be resource intensive. It is essential to target these efforts to those populations for which the most new cases are treated and/or prevented, and for whom the consequences of transmission are greatest. Therefore, the highest priority populations for health department STD partner services are: pregnant women with syphilis and other women of reproductive age with early syphilis, followed by men with primary and secondary syphilis whose partners are pregnant or are other women of reproductive age. The provision of EPT to partners of patients with chlamydia or gonorrhea is another high priority disease intervention approach under this program.

Conducting disease investigation for MSM diagnosed with primary and secondary syphilis is also important. However, services for MSM clients should be highly targeted for maximum syphilis prevention cost effectiveness. Outcome data should be routinely collected to enable programs to assess intervention effectiveness. Decisions about which subgroups of MSM with primary and secondary syphilis to target for health department disease investigation, and how they should be engaged, should be made at the project area level, driven by program data and evidence of highest public health value. In addition to comprehensive STD testing, MSM partner services should include HIV testing, viral load testing, linkage to HIV care, re-engagement in HIV care, and linkage and navigation for PrEP and other HIV prevention services, as appropriate for each partner's HIV serostatus and care status.

Applicants should explore innovative disease investigation and intervention models that may increase the cost-effectiveness, scale and impact of these strategies for the populations served, and contribute to the evidence base for these services. For these innovative models, sufficient evaluation, including collection of cost and outcome data to determine cost-effectiveness in comparison to existing models, should be conducted. Some examples may include network models for partner services; the use of digital media and technology to increase the efficiency of services; implementation of express services in clinical settings that serve partners identified through disease investigation; and improvements in identifying individuals or groups for whom these strategies will have the greatest impact. Recipients are encouraged to implement, evaluate, and disseminate partner-services models that increase the impact of these strategies on a http://www.phaboard.org/dis-certification/ https://www.cdc.gov/std/ept/default.htm https://www.cdc.gov/std/ept/default.htm population level.

Disease investigation and intervention activities including outbreak response and partner services should be allocated approximately 20-30% of program effort under this NOFO.

6. Respond to STD-related outbreaks

a) Review STD surveillance data by the core epidemiologic variables at regular intervals to identify outbreaks and other significant changes in STD epidemiology

b) Develop and maintain an outbreak capacity plan to respond to significant changes in STD epidemiology. Ensure that staff are trained and ready to implement the outbreak capacity plan

7. Conduct health department disease investigation and intervention for pregnant women with syphilis and other reproductive-age women with syphilis

a) Prioritize for investigation all reported cases among females of reproductive age and reactive serology, including provider follow-up to confirm stage, treatment and pregnancy status

b) Regardless of pregnancy status, conduct follow-up on new syphilis cases among women of reproductive age, to obtain more information, if needed, on treatment and other information needed to ensure linkage to related STD, MCH, and HIV prevention and other services. For those who are pregnant, investigation should also include follow-up with the pregnant female, prenatal care providers, birthing centers, and neonatal care providers as needed to ensure adequate maternal follow up and stillbirth and neonatal evaluations per clinical guidelines

c) Provide timely partner services to all pregnant women who are diagnosed with syphilis and all other women of reproductive age who are diagnosed with early syphilis

8. Promote Expedited Partner Therapy (EPT) (where permissible) to partners of chlamydia and/or gonorrhea cases

a) Assess EPT practices to identify and prioritize providers, organizations, and areas to target for promotion and improvement. Provide technical assistance and education to promote EPT to providers and organizations who frequently report cases of chlamydia and/or gonorrhea, including cases of repeat infections

9. Conduct health department syphilis disease investigation and intervention for men with primary and secondary syphilis

a) Conduct follow-up on primary and secondary syphilis cases among men, to obtain more information, if needed, on treatment, sex of sex partners, HIV serostatus, HIV care status, PrEP use, and other information to ensure linkage to appropriate STD and HIV related prevention services

b) Provide timely and comprehensive partner services to men with primary and secondary syphilis who report pregnant or other female partners of reproductive age

c) Use program and epidemiologic data to identify subgroups of MSM with primary and secondary syphilis and factors associated with transmission to target for partner services to yield high numbers of all partners treated in a timely fashion, and for whom consequence of transmission is the greatest. As resources permit, provide timely partner services including comprehensive STD and HIV testing and linkage to care and needed prevention services to those subgroups of MSM with primary and secondary syphilis

Strategy Area III: Promote CDC-Recommended Screening, Diagnosis, and Treatment These strategies and activities include supporting and promoting recommended STD clinical guidelines. To reduce the burden of STDs, routine screening for STDs, timely detection, and recommended treatment of infections are necessary. These services are predominantly implemented by the health care system. Even if an applicant is not engaged directly in providing STD clinical care, applicants have a responsibility to be a resource for quality STD clinical care and promote the latest recommendations for quality clinical services.

Clinics that offer specialized STD care play a critical role in rapidly identifying and treating people with STDs as well as their partners. Specialized STD care is typically delivered in settings that focus on providing timely, comprehensive, confidential and culturally sensitive STD care. STD specialty-care clinics facilitate access to STD testing, diagnosis, and treatment, and serve as a vital resource in the course of disease investigation and intervention. Close collaboration between applicants and their project area's STD specialty care clinics is essential to ensure seamless implementation of disease investigation and intervention and to ensure access to quality care in those settings.

The highest priority STD clinical care issues to promote include screening adolescents and young adults, MSM, and pregnant women for STDs, as well as the recommended, timely treatment of those individuals who test positive. Applicants are expected to identify "hot spots" in their project areas based on an analysis of STD surveillance data, as well as available screening and treatment data, and target their efforts to promote STD screening and treatment practices in particular areas or among particular providers or organizations.

Recommended screening and treatment can be promoted using a variety of methods. For example, health departments can educate select providers about relevant clinical guidelines and recommendations. They can use screening rate and treatment data to describe how certain areas or providers compare, share best practices, and encourage improvement. Applicants also are encouraged to promote, develop, and evaluate innovative methods to increase access to quality STD care. These methods might involve supporting screening in non-traditional venues such as pharmacies, encouraging visits with standing orders for patients who are risk and without symptoms, or supporting learning collaboratives (opportunities for peer-to-peer sharing, program improvement, and capacity building) with staff from HIV care or primary care clinics.

Applicants are required to facilitate the involvement of the National Network of Prevention Training Centers (NNPTCs) and should involve other local STD academic or practicing clinical experts to bolster the promotion and support for quality STD clinical care conducted by health department STD programs.

Applicants are required to promote screening, treatment, and other practices recommended through CDC-issued guidelines, including the STD Treatment Guidelines (https://www.cdc.gov /std/tg2015/default.htm). Applicants should also apply the principles of Program Collaboration and Service Integration (PCSI) in their work to promote recommended screening, diagnosis, and https://www.cdc.gov/std/tg2015/default.htm https://www.cdc.gov/std/tg2015/default.htm treatment for populations at risk of other related infectious diseases (https://www.cdc.gov/nchhs tp/programintegration/). They should seek opportunities to support recommended practices for HIV, TB, HPV, viral hepatitis, and other related public health issues to the extent feasible in their work with health care providers and organizations.

Health department STD programs have an important role in supporting, promoting, and assuring all of the screening and treatment strategies outlined below. Project areas are expected to use their local data and other contextual information to prioritize among these strategies and related activities and to decide where/how to allocate their efforts accordingly, in consultation with

CDC.

The promotion of CDC-recommended screening, diagnosis, and treatment practices should be allocated approximately 20-30% of program effort under this NOFO.

Assistance for STD clinical prevention services In addition, applicants may provide assistance, no more than 10 percent of the overall award amount without prior approval from CDC, to not-for-profit or governmental clinics that can document their ability to provide safety-net STD clinical preventive services as per CDC guidance. At a minimum, clinics receiving assistance should have the capacity to rapidly diagnose and treat bacterial STDs. This assistance could be used to screen, diagnose, or treat uninsured and underinsured people. Applicants must have memoranda of understandings (MOU), contracts, or other forms of written agreements describing the terms of this assistance with the organizations that receive it. CDC may request copies of these agreements throughout the period of performance.

These activities should be conducted in compliance with CDC's STD Treatment Guidelines, and as permitted under relevant federal, state, and local laws and regulations. CDC reserves the right to reduce the allowable amount that may be used to support these services in subsequent years.

This funding can be used to purchase and dispense Benzathine penicillin G for the treatment of syphilitic infections among uninsured and underinsured patients and their sex partners whose clinical service providers are not able to administer timely treatment with Benzathine penicillin G. Providing prompt treatment to reduce the spread of syphilis in the community is a core public health function required in many states by statute or regulation (https://www.cdc.gov /nceh/ehs/ephli/core_ess.htm). In these critical public health situations, Benzathine penicillin G should be provided under medical orders of the medical director of the STD program or the health department. The health department physician prescribing the Benzathine penicillin G must keep a medical record of all patients treated under his or her orders. Upon request, CDC may approve funding for other STD treatments to respond to local STD outbreaks or other urgent public health threats related to sexually transmitted infections.

10. Promote quality STD specialty care services

a) Identify all STD specialty clinics in the project area

b) Promote quality STD care in those settings based on clinical guidelines and recommendations, and promote strategies for expanding access to care in those settings https://www.cdc.gov/nchhstp/programintegration/ https://www.cdc.gov/nchhstp/programintegration/ https://www.cdc.gov/nceh/ehs/ephli/core_ess.htm https://www.cdc.gov/nceh/ehs/ephli/core_ess.htm

11. Promote CDC-recommended treatment for gonorrhea and syphilis

a) Assess GC treatment practices to identify and prioritize providers, organizations, and areas to target for promotion and improvement. Provide education and technical assistance to providers and organizations who prescribe non-recommended treatment for gonorrhea

b) Assess syphilis treatment practices to identify and prioritize providers, organizations, and areas to target for promotion and improvement. Provide education and technical assistance to providers and organizations who prescribe non-recommended treatment for syphilis

c) Implement a Benzathine penicillin G forecasting inventory-management system to monitor supply, and have a plan to address shortages in the applicant's project area. Assist providers and organizations who are unable to provide timely, recommended treatment for syphilis in getting access to medication or dispensing the treatment to the patient, as needed

12. Promote CDC-recommended screening, diagnosis, and treatment of STDs among high priority populations

a) For pregnant women: Assess screening and treatment practices to identify and prioritize providers, organizations, and areas to target for promotion and improvement.

Provide education and technical assistance for prenatal-care providers and organizations who do not regularly screen for syphilis as recommended

b) For young adults and adolescents, particularly those seen in family planning clinics, adolescent health clinics, and primary care settings: Assess screening and treatment practices to identify and prioritize providers, organizations, and areas to target for promotion and improvement. Provide education and technical assistance to targeted providers and organizations to promote recommended screening and treatment

c) For MSM, particularly those seen in lesbian, gay, bisexual, transgender and queer/questioning (LGBTQ) health centers, HRSA-funded HIV care settings, primary care settings, and clinics providing HIV PrEP: Assess screening and treatment practices to identify and prioritize providers, organizations, and areas to target for promotion and improvement. Provide education and technical assistance to targeted providers and organizations, to promote recommended screening and treatment

Strategy Area IV: Promote STD Prevention and Policy These strategies and activities encourage the promotion of STD-related health issues to a broad range of stakeholders. Health promotion is critical to empowering the public to make healthy decisions and to empowering health care providers to support public health goals. Health promotion includes leveraging the power of digital media to provide information on STDs and STD services. It also leverages the power of professional networks to expand the audience for professional-level communications about STD surveillance and epidemiology, STD clinical care, health education, and management of patients and their partners.

To the extent possible, programs should participate in health-promotion activities supported by other organizations (e.g., HIV, MCH, local medical associations).