CDC-RFA-PS19-1907.pdf

Centers for Disease Control

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

STD Surveillance Network (SSuN)

CDC-RFA-PS19-1907

Application Due Date: 05/15/2019

STD Surveillance Network (SSuN)

CDC-RFA-PS19-1907

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (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-PS19-1907. 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:

STD Surveillance Network (SSuN) 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-PS19-1907

E. Assistance Listings (CFDA) Number:

93.977 F. Dates:

1. Due Date for Letter of Intent (LOI): 04/15/2019

2. Due Date for Applications: 05/15/2019, 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:

(1) Tuesday, March 12, 1 - 2 PM Eastern Standard Time (https://cc.readytalk.com/r/r7myqz6hdr fp&;eom), and,

(2) Tuesday March 19, 3:30 - 4:30 PM Eastern Standard Time (https://cc.readytalk.com/r/mi2qi ecr329i&;eom).

G. Executive Summary:

1. Summary Paragraph:

CDC announces availability of fiscal year 2019 funding for a cooperative agreement for the STD Surveillance Network (SSuN). In light of resurgent sexually transmitted diseases (STDs), and a public health imperative to respond to related epidemics such as HIV, this program proposes new approaches to community-based enhanced and sentinel surveillance that integrates monitoring of STDs, HIV and behavioral data. The data will be used to identify 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 https://cc.readytalk.com/r/r7myqz6hdrfp&eom https://cc.readytalk.com/r/r7myqz6hdrfp&eom https://cc.readytalk.com/r/mi2qiecr329i&eom opportunities and gaps in prevention and control efforts. Systematic, ongoing collection of patient-level information to monitor the occurrence of, and factors associated with, STDs is the foundation upon which STD control programs are based. Reporting by clinicians, laboratories and healthcare facilities is limited and does not provide information needed to characterize STDs and co-occurring epidemics, to identify populations at risk for adverse health impacts, or to identify opportunities and gaps in sexual health and preventive services. This NOFO addresses these information needs, and incorporates flexibility to respond to emergent health issues related to STDs by supporting a network of geographically diverse health departments and STD-related clinical partners to implement protocol-based surveillance activities. These activities complement existing surveillance strategies. They also expand the capacity of health departments to collect high-quality, timely data to inform disease prevention and control activities.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 10

d. Total Period of Performance Funding: $24,000,000

e. Average One Year Award Amount: $480,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 08/15/2019

h. Cost Sharing and / or Matching Requirements: N 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

Part II. Full Text

1. Background

a. Overview Three curable bacterial sexually transmitted diseases (STDs): chlamydia (CT), gonorrhea (GC), and syphilis are nationally notifiable and have historically been the focus of federally funded STD prevention programs throughout the U.S. In 2017, 2.3 million cases of these STDs were reported to CDC, reflecting an increase of 35% since 2013[1]. However, these cases do not fully reflect the burden of STDs as many infections are asymptomatic and never diagnosed and reported - and this does not include other STDs that are not nationally notifiable. STDs can have long-term health consequences in addition to the immediate impact on an individual's health. STDs are also an economic burden on the U.S. healthcare system costing billions annually[2]. Persons with STDs are at risk for acquisition or transmission of HIV and represent a population essential to national efforts to end the HIV epidemic and reduce the spread of STDs.

Monitoring populations seeking care in STD clinics, along with documenting the eligibility and receipt of STD-related HIV preventive interventions, will directly contribute to the development of local, state and national STD/HIV interventions to reduce the burden of disease. Specialty STD clinical facilities and other sexual health clinics, provide safety net services to populations at risk for acquiring STDs and HIV. STD clinics are ideal settings to link HIV-negative patients to preventive services (e.g., Pre and post exposure prophylaxis, PrEP/PEP). They are also positioned to re-engage or link persons living with HIV to treatment. Monitoring these services at the patient level can help identify gaps and missed opportunities for STD and HIV preventative care. A robust network of high-quality specialty STD clinical facilities provides the capacity for CDC and collaborators to investigate additional STD issues related to health care seeking behaviors, social determinants of health, and health disparities in these STD-specific clinical contexts.

However, a large proportion STDs are diagnosed outside of STD clinics. As the burden of STDs increases nationally, surveillance systems at the state and local level struggle to ascertain complete information on the characteristics of individual cases reported as well as the potential for co-occurring conditions among persons diagnosed and reported with STDs. This information is essential for understanding why STDs are increasing, for determining population-level differences in health equity and for monitoring adverse health outcomes of STDs.

Conducting enhanced surveillance activities among a representative sample of individuals diagnosed with STDs across all provider settings is imperative for monitoring the uptake of prevention interventions known to reduce STDs and HIV transmission at the population level.

These data are also critically needed to describe trends in co-incidence of STDs and HIV among at-risk and vulnerable populations and identify factors associated with STD transmission, information essential to steering prevention and control efforts in both the public and private health care sectors.

A comprehensive approach to sentinel and enhanced surveillance, supporting core strategies focused on persons with, or at demonstrable risk for STDs and other co-occurring conditions across the full range of community settings is the primary public health objective of this NOFO.

This program builds upon a foundation of previous STD Surveillance Network (SSuN) collaborations providing strong evidence of the efficacy and utility of these core surveillance strategies[3,4].

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

c. Healthy People 2020 This project addresses the Healthy People 2020 focus area(s) of Sexually Transmitted Diseases:

https://www.healthypeople.gov/2020/topics-objectives/topic/sexually-transmitted-diseases.

Healthy People 2020 (http://www.healthypeople.gov) contains national objectives to improve the health of all Americans by encouraging collaborations across sectors, guiding people toward making informed health decisions, and measuring the impact of prevention activities.

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

d. Other National Public Health Priorities and Strategies This NOFO supports the goals of NCHHSTP to decrease incidence of infection, decrease morbidity and mortality, and decrease health disparities associated with HIV, viral hepatitis, STDs and TB by implementing programs, policies and research that are guided by the principle of high impact prevention (HIP). In addition, this NOFO supports a holistic framework that enables NCHHSTP to more comprehensively address the broader, cross-cutting issues of health and wellness by addressing Health Equity and Program Collaboration and Service Integration (PCSI). Health equity entails special efforts to improve the health of those disproportionately affected by disease. PCSI supports programmatic efforts to integrate and improve efficiency when addressing syndemics among populations with or at risk for at least two or more infections in the following areas: HIV, Viral Hepatitis, STD, and TB. Additional information about the goals and strategies of NCHHSTP, Health Equity, and PCSI is available: http://www.cdc.gov /nchhstp 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/drugresist ance/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

e. Relevant Work This NOFO builds upon previous and existing STD and HIV surveillance programs:

PS13-1306: STD Surveillance Network (SSuN) https://www.cdc.gov/std/ssun/default.htm PS18-1802: Integrating HIV Surveillance and Prevention Programs for Health Departments https://www.cdc.gov/hiv/funding/announcements/ps18-1802/index.html PS19-1901: Strengthening STD Prevention and Control for Health Departments (STD PCHD) https://www.cdc.gov/std/funding/pchd/default.htm 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 http://www.cdc.gov/nchhstp http://www.cdc.gov/nchhstp https://www.cdc.gov/std/syphilis/syphiliscalltoactionapril2017.pdf https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.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.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.hiv.gov/federal-response/national-hiv-aids-strategy/overview https://www.hiv.gov/federal-response/national-hiv-aids-strategy/overview https://www.cdc.gov/std/ssun/default.htm https://www.cdc.gov/hiv/funding/announcements/ps18-1802/index.html https://www.cdc.gov/std/funding/pchd/default.htm https://www.cdc.gov/std/gisp/default.htm https://www.cdc.gov/std/gonorrhea/arg/carb.htm

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-PS19-1907 Logic Model: STD Surveillance Network (SSuN)

i. Purpose The purpose of this NOFO is to enhance capacity for STD surveillance and better meet CDC's disease surveillance mandate. Recipients funded under this NOFO will: 1) implement protocol-based sentinel surveillance in STD clinics, including periodic patient surveys and routine matches with HIV surveillance records; 2) implement protocol-based enhanced case surveillance, including HIV registry matching; 3) conduct short-term activities to monitor consequences of STDs to further strengthen overall surveillance efforts; and, 4) provide technical assistance to state and local STD surveillance staff.

ii. Outcomes Expected program outcomes for the performance period include:

Short-Term Outcomes o 1.1 Improved monitoring of patient characteristics, STD/HIV-risk and repeat infections (Strategies A-C) o 1.2 Improved monitoring of patient-level eligibility for and uptake of STD-related HIV preventive services. (Strategies A & B) o 1.3 Improved timeliness, data completeness and data quality. (Strategies B & C) o 1.4 More timely dissemination of findings informing STD/HIV control and prevention policy. (Strategies A-C) o 1.5 Annual data quality reporting. (Strategies A-C) o 1.6 Dissemination of surveillance data products to providers, health department and community stakeholders. (Strategies A-C) o 1.7 Dissemination of findings in STD/HIV-related journals and publications. (Strategies

A-C)

Intermediate Outcomes o 2.2 Improved, timely monitoring of HIV and STD-specific clinical and preventive services in STD-specific clinical settings. (Strategies A & C) o 2.5 Improved monitoring of patient treatment in STD clinics. (Strategy A) o 2.6 Improved monitoring of disease burden by relevant patient characteristics in community settings. (Strategies B & C) o 2.7 Monitoring of trends in HIV status, PrEP referral and use, HIV care among STD cases diagnosed in community settings. (Strategies B & C)

Long-Term Outcomes o 3.2 Improved provider compliance with STD/HIV screening, preventive services and treatment guidelines. (Strategies A-C)

Recipients will collaborate with CDC in demonstrating measurable progress toward achieving these short, medium and long term outcomes (those appearing in bold in the logic model).

iii. Strategies and Activities Recipients funded under CDC-RFA-PS19-1907 are expected to fully implement project protocols for sentinel and enhanced STD surveillance activities for Strategies A & B.

Recipients will routinely transmit relevant, uniquely identified case, investigation and clinic visit records, including required HIV-related information (HIV exposure, earliest documented HIV-positive test, viral load and CD4+ tests within one year of patient STD clinic visit or STD diagnosis) obtained through HIV surveillance registry matches routinely to CDC in specified formats and at specified intervals. Implementation of all activities described below for Strategies A & B must be fully addressed by all applicants in their work plan. Protocols for Strategy A and Strategy B activities are available at https://www.cdc.gov/std/funding/ssun/defau lt.htm.

Recipients are also expected to propose to participate in at least one Strategy C (Surveillance Focus Activities) activity each project year, depending on the availability of funding. Applicants should develop proposals for at least one but not more than five focus activities of local interest. Proposals for each Strategy C activity should be separate from Strategies A & B activities; with each proposed Strategy C activity having a separate narrative (no more than 1 page single spaced, 12-point font) and separate budget justification. Any proposed Strategy C activities should also be addressed in the applicant's work plan.

Strategy A - Protocol-based sentinel surveillance in STD Clinics For the purposes of this NOFO, STD clinics are defined as any clinical facility providing timely, comprehensive, confidential, and culturally sensitive STD care as the facility's primary function.

Clinics need not be 'stand-alone' and may be integrated into broader practice settings. However, the selected facility must have a specifically identifiable STD clinic and have the ability to identify and extract records from their electronic health records system(s) for patients specifically seeking STD clinical services separately from any broader patient population.

At least one STD clinic proposed for inclusion in Strategy A activities must have a volume of at least 5,000 documented patient visits annually for STD-related clinical services, provide active management of (or documented referral to) PrEP/PEP, collect and be able to transmit key variables (demographics, gender of sex partners, symptoms, anatomic site(s) of testing, HIV testing and HIV status, PrEP referral/use) and agree to submit patient names to the recipient agency for HIV registry matching. These requirements must be explicitly documented in a separate MOU/MOA or Letter of Collaboration (LOC) for each collaborating STD clinic (or network of administratively associated STD clinics if appropriate). Where multiple STD clinics in a jurisdiction are proposed, at least one (1) individual STD clinic site must meet the minimum volume requirement of at least 5,000 visits per year and provide active management of (or documented referral to) PrEP/PEP for eligible patients.

1.1 Recipients will identify one or more STD clinic(s) in their jurisdiction as collaborating partners in sentinel surveillance activities. Where multiple facilities are potential candidates for inclusion, criteria for selection should be described and applied including provision of PrEP/PEP (or documented referrals for PrEP/PEP), patient volume, geographic representativeness within jurisdiction, and patient characteristics (i.e. higher risk for HIV, socioeconomic characteristics, etc.).

1.2 Recipients will collaborate with selected STD specialty clinical facilities to routinely obtain visit-level clinical records for all patients receiving STD or sexual health services in the collaborating STD clinics, including all data elements specified in project protocols, and at intervals sufficiently timely to fulfill project protocols.

1.3 Recipients will collaborate with selected STD specialty clinical facilities to routinely obtain patient demographics (age, sex, race, sexual orientation, gender identity, etc.), behavioral data (e.g. gender of sex partners) and STD-related HIV preventive services received (e.g. PrEP/PEP, etc.) with all visits. Visit records must include all data elements https://www.cdc.gov/std/funding/ssun/default.htm specified in project protocols, and be extracted and transmitted to the recipient at intervals sufficiently timely to fulfill project protocols.

1.4 Recipients will collaborate with selected clinical facilities to routinely obtain laboratory records associated with tests performed at the STD clinic visit, including all laboratory data elements specified in project protocols and at intervals sufficiently timely to fulfill project protocols.

1.5 Recipients will collaborate with selected STD specialty clinical facilities to routinely obtain diagnosis data associated with all visits, including all diagnosis-related data elements, diseases and conditions specified in project protocols, and at intervals sufficiently timely to fulfill project protocols.

1.6 Recipients will collaborate with selected STD specialty clinical facilities to routinely obtain treatment data associated with all visits, including all treatment-related data elements specified in project protocols, and at intervals sufficiently timely to fulfill project protocols.

1.7 Recipients will collaborate with selected STD specialty clinical facilities to obtain patient identifiers associated with clinic visit records to routinely match patients against the jurisdiction's HIV case registry (such as eHARS or similar local, comprehensive HIV case registry) and STD registry at intervals sufficiently timely to fulfill project protocols. This may be accomplished through separate patient index files maintained at the recipient health department (a master patient index) or using other methods deemed appropriate by health department and HIV surveillance program collaborators. Recipients will obtain available HIV diagnostic and HIV laboratory data for matching patients (limited to earliest recorded initial HIV-positive diagnostic test and date, HIV viral load tests/dates within one year of patient STD clinic visit date, CD4+ tests/dates within one year of patient STD clinic visit date). Recipients will collaborate with HIV surveillance programs to address reciprocal information sharing to assure that desired patient demographics, sexual orientation, gender identity, HIV testing and/or treatment, HIV-related risks and preventive services are available to HIV surveillance staff for related evaluations and to enhance the completeness of HIV case surveillance data. There is no requirement for HIV match data to be shared back to clinical facilities for the purpose of patient-level interventions or public health actions. However, in consultation with CDC and the jurisdiction's HIV surveillance and prevention programs, recipients may use these data for assessing and addressing gaps in HIV preventive services as locally determined. Applicants must document any and all data sharing activities in their Data Management Plan (DMP, see section b. Evaluation and Performance Measurement, below).

1.8 In collaboration with health department Overall Responsibility Party (ORP), recipients will assure that patient name-based identifiers are redacted in all archived datasets and replaced with non-name-based unique identifiers; name-based identifiers must be removed from all datasets prior to transmission to CDC.

1.9 Recipients will collaborate with CDC and with selected STD specialty clinical facilities to implement periodic, brief patient surveys. At least one (1) survey administration period must occur in the first funding year with a minimum of 350 patient/respondents in each data collection cycle (CDC survey protocols may be varied in subsequent project years).

Survey methods must be designed to allow capture of self-reported voluntary responses from all patients seen consecutively during the survey administration interval. Patients should respond to the survey prior to receipt of their clinical services (e.g., in the registration area/waiting room). Patient duplication during the survey period is allowed, but only a single survey should be administered/collected per visit. Survey data may be linkable to the associated clinic visit record for patients through appropriate identifiers where feasible (unique visit ID, medical record number, patient name, etc.; jurisdictions may pilot various methods to link with clinical records in the first or subsequent years).

Jurisdictions may propose paper-based or technology-assisted data collection methods, as appropriate for their STD specialty clinical settings to obtain these self-administered survey data. Recipients with multiple STD specialty clinic sites should consider survey administration in higher-volume clinics (>5,000 visits per year) and may propose rotating between participating clinics with this volume annually as needed to fully represent the jurisdictions STD specialty clinic population. Data entry of survey data (if needed based on methods proposed) may be accomplished at the clinic site, or surveys aggregated at a central location for data entry based on recipient needs.

1.10 Recipients will collaborate with STD specialty clinical facilities to collect data in the first year describing the individual clinic site's STD & HIV screening, testing, treatment policies, inventory of services (including linkage to HIV care) and service types provided (e.g. express versus clinician visit), PrEP and PEP referral/provision policies and other information necessary for interpretation of patient-visit data. These data must be collected, updated and reported to CDC for all STD specialty clinics contributing data in the first year and updated throughout the project period.

1.11 Recipients will assure timely and prompt data quality assurance, including recoding source data into required formats, application of CDC-provided edit and completeness checks to datasets prior to transmission, address all identified data issues prior to transmission and securely transmit all required datasets to CDC following protocols and data transmission schedules.

1.12 Recipients will assure that measures, methods and processes are developed and implemented to provide timely data quality feedback to collaborating facilities and to assure remedial actions and processes are implemented to improve data collection and quality in the event challenges are identified locally or by CDC.

Expected outputs associated with Strategy A activities:

a) Dataset of uniquely identified STD speciality clinic visits - transmitted per protocol to CDC every 2 months

b) Dataset of laboratory data associated with each STD speciality clinic visit - transmitted per protocol to CDC every 2 months

c) Dataset of diagnoses associated with each STD speciality clinic visit - transmitted per protocol to CDC every 2 months

d) Dataset of treatment data associated with each STD speciality clinic visit - transmitted per protocol to CDC every 2 months

e) Dataset with STD clinic survey records - transmitted per protocol to CDC annually

f) Dataset with STD clinic metadata relating to clinic policies - transmitted per protocol to CDC annually

Strategy B - Enhanced Case-Based Population Surveillance

2.1. Recipients will implement processes to identify a random, probability sample of all STD cases (chlamydia, gonorrhea, syphilis, chancroid) reported in their jurisdiction. These processes must allow the flexibility to vary a sampling fraction independently between diseases and geographic sub-units (if applicable) in their jurisdiction. The most appropriate way to implement case sampling is within the surveillance data management system by assigning and appending a system-generated random number to each 'case record' entered into their system, regardless of source of report (laboratory, provider, facility, etc.). This random number will then be used to select a probability sample of cases, either externally to the system or with a logic stored within the data management system, for additional investigation as needed for surveillance, evaluation or quality assurance purposes.

2.2. Recipients will collaborate with CDC to conduct routine assessments of the recipient's probability sampling method by disease and by geography to assure that there are no systematic sampling biases and to assure that all reported cases have an equal probability of being sampled within the recipient jurisdiction and/or geographic subunit. There will be no replacement sampling; if a case is found to be a duplicate, out of jurisdiction, or false-positive test through investigation, this should be documented in data submitted in compliance with protocols.

2.3. Recipients will extract records from the recipient's STD surveillance data management system for all cases of gonorrhea diagnosed and reported among residents of the recipient's jurisdiction, regardless of source of report. Case records must include a unique, static patient identifier, unique case identifier, random sample indicator, and all other required data elements per CDC protocols and recoded in appropriate formats and structures as specified in project protocols for submission to CDC. Syphilis and gonorrhea treatment information, in addition to core demographic, behavioral, clinical and partner services data, are required data elements for core surveillance for PS19-1901, STD-PCHD; project staff at CDC will coordinate with STD-PCHD to assure streamlined reporting.

2.4. Recipients will extract records from the recipient's STD surveillance data management system for all cases of adult (non-congenital) syphilis diagnosed and reported among residents of their jurisdiction, regardless of source of report. Case records must include a unique, static patient identifier, unique case identifier, random sample indicator, and all other required data elements per CDC protocols and recoded in appropriate formats and structures as specified in project protocols for submission to CDC. Syphilis and gonorrhea treatment information, in addition to core demographic, behavioral, clinical and partner services data, are required data elements for core surveillance for PS19-1901, STD-PCHD;

project staff at CDC will coordinate with STD-PCHD to assure streamlined reporting.

2.5. Recipients will conduct look-back investigations using disease surveillance registries for all gonorrhea and adult syphilis cases in compliance with CDC protocols; the purpose of these investigations is to assure de-duplication of persons and cases, obtain history of previous STD/HIV diagnoses and to obtain additional information that may be present in existing surveillance records to assist in patient follow-up. Data from these investigations will be embedded in case records and transmitted to CDC in compliance with SSuN protocols.

2.6. Recipients will routinely match all reported gonorrhea and adult syphilis case records with their local HIV surveillance registry (eHARS or similar official, comprehensive HIV case registry) to obtain and retain local HIV case number, earliest documented date of HIV infection, transmission category (as captured in the HIV case record), most recent viral load testing (date and result), and most recent CD4+ testing (date and result). Date of initial and most recent registry matching/searches must be documented for all cases. For matched cases, recipients must provide relevant patient-level information back to HIV surveillance/prevention units to help resolve cases reported to HIV surveillance with no reported risk (NRR), to better monitor HIV care status, to refer and/or re-link patients to HIV care, to monitor prevalence patterns by current residence and to better understand gaps in, and opportunities for, promotion and uptake of HIV prevention interventions. Recipients will collaborate with HIV surveillance programs to address reciprocal information sharing to assure that desired patient demographics, sexual orientation, gender identity, HIV testing and/or treatment, HIV-related risks and preventive services are available to HIV surveillance staff for related evaluations and to enhance the completeness of HIV case surveillance data. Applicants must document any and all data sharing activities in their Data Management Plan (DMP, see section b. Evaluation and Performance Measurement, below).

2.7. Recipients will conduct provider investigations for a random sample of all gonorrhea cases in the entire jurisdiction in compliance with SSuN protocols. Provider investigations with the diagnosing/reporting provider or facility will include verification and ascertainment of gonorrhea treatment (drugs & doses), signs/symptoms, anatomic site(s) of infection, gonorrhea screening by anatomic site, insurance status, preventive services, HIV status, HIV testing and to obtain additional contact information from the provider to assist in obtaining patient interviews. Methods proposed may include fax-based forms, enhanced case reports, telephone follow-up, electronic access to clinical records or a mixture of such methods as locally appropriate. Data from these investigations will be embedded in case records transmitted to CDC in compliance with SSuN protocols.

2.8. Recipients will attempt to obtain patient interviews with a random sample of gonorrhea cases reported throughout their jurisdiction in compliance with protocols to ascertain required behavioral and demographic information. At least 4 attempts at patient contact are required and outcomes of each contact attempt must be fully documented before abandoning attempts and closing the record as 'unable to contact'. Recipients are required to implement measures to maximize interview completion rates such as assuring interview attempts can be initiated and/or patient call-backs can occur during limited evening hours and on Saturdays. Interview completion rates among sampled cases will be a primary performance measure. Jurisdictions should implement expansive measures to obtain patient contact information and should include social media searches, the provider's patient or emergency contact information, ancillary state administrative databases and any other available methods. Patient interviews may be conducted by telephone as the primary interview method. All local procedures for confirming the identity of the patient prior to discussing confidential information must be followed for SSuN enhanced case investigations. Data from these investigations will be embedded in case records transmitted to CDC in compliance with SSuN protocols.

2.9. The target sample size for enhanced gonorrhea case investigations should be determined by overall morbidity reported in the jurisdiction. For jurisdictions with >50,000 cases reported in 2017, the minimum acceptable target for completed case investigations is 2.5% of all reported cases; for jurisdictions with 30,000 - 50,000 cases reported in 2017, the minimum acceptable target for completed case investigations is 3.0% of all reported cases for jurisdictions with 10,000 - 30,000 cases reported in 2017, the minimum acceptable target for completed case investigations is 3.5% of all reported cases, for jurisdictions with <10,000 cases reported in 2017, the minimum acceptable target for completed case investigations is 4% of all reported cases. Complete case investigations in this context refers to complete patient interviews. CDC expects interview success rates (defined as completed interviews divided by cases randomly sampled) to meet or exceed 65% and to result in a minimum of completed interviews in each budget period as defined by the percentages specified above.

2.10. Recipients will collaborate with CDC to identify, plan, conduct, document and disseminate project findings for STD surveillance technical assistance and evaluation activities related to STD-PCHD-funded surveillance components. The objective of these activities is to improve core surveillance capacity and provide technical assistance to non- SSuN funded, STD-PCHD jurisdictions. Examples of such surveillance evaluation activities may include but are not limited to: (A) assessments of data completeness for laboratory reporting and recommendations for improving ascertainment of key data elements, (B) assessment of the population-level coverage of electronic laboratory reporting (ELR) and/or electronic health records (EHR) and recommendations for enhancing ELR and/or EHR coverage to include all laboratories or providers in the jurisdiction, (C) enhancing the completeness of provider type variables in routine case surveillance and recommendations for more useful taxonomies for provider types, (D) assessing robustness of person-identifier to longitudinally monitor unique persons with recommendations for best practices, (E) assessing specificity/sensitivity of registry matching methods and recommendations for fully integrating automated registry matching, and/or, (F) other surveillance evaluation activity of local interest investigating quality/completeness of STD-specific surveillance data. Recipients should conduct data improvement activities to identify best practices and develop tool kits for dissemination.

2.11. Recipients will collaborate with CDC to assure timely and prompt data quality assurance on all required datasets, including recoding into required structures and formats, application of CDC-provided edit and completeness checks, remedial action to address deficiencies prior to data transmission and secure transmission of all required datasets to CDC following project protocols and schedules.

Expected outputs associated with Strategy B activities:

a) Dataset of all reported gonorrhea and adult syphilis cases with unique patient, case and provider IDs, HIV match results, provider and case investigations for randomly sampled cases - transmitted per protocol to CDC every 2 months

b) Dataset of all STD/HIV related laboratory data associated with each case record -transmitted per protocol to CDC every 2 months

c) Dataset of unique providers reporting STD cases - transmitted per protocol to CDC at least once annually

Strategy C - Surveillance Focus Activities These activities are intended to improve quality and use of surveillance data, explore new methods for monitoring the burden of reportable and/or non-reportable STDs, investigate incidence of sequelae and monitor adverse health outcomes of STDs across the full range of laboratory and provider settings. Applicants are required to apply for at least one (1) but no more than five (5) surveillance focus activities. Applicants must include separate budgets and address the activity in the applicant's work plan for each proposed activity. Applicants should base their budget request on current morbidity levels or anticipated volume; maximum budget request estimates are provided in the budget narrative section (Section 12 below) for each activity.

Activity 3: Lymphogranuloma venereum (LGV) surveillance among persons seeking care in STD clinics

3.1 Applicants are invited to propose methods, staffing and infrastructure in collaborating STD clinics to collect remnant CT-positive (by NAAT testing) rectal swabs/specimens from both symptomatic and asymptomatic male and female patients for shipment to the CDC laboratory for testing to determine the prevalence of LGV serovars.

3.2 Recipients may collect specimens continuously for a specified period of time, or sequentially until 200 specimens are obtained per participating clinic.

3.3 Recipients must be able to link specimens to SSuN clinic visit record through unique SSuN patient ID and visit date.

Expected outputs:

a) Dataset of all specimens collected and shipped with event IDs linking specimens to Strategy A datasets - transmitted per protocol to CDC

Activity 4: Enhanced cases investigations among a sample of reported chlamydia cases in a high morbidity area

4.1 Following protocols specifying a limited set of pre-defined demographic, clinical and behavioral data elements, recipients will conduct enhanced provider and brief patient follow-up investigations on a random probability sample of reported chlamydia cases in a well-defined high morbidity county, neighborhood planning area or health planning region within the recipient's jurisdiction for two (2) discrete time periods per project year.

4.2 Recipients will use the same methods to select a random sample of CT cases that they employ for the selection of cases in Strategy B (2.1 above). Similarly, applicants should describe methods for assuring that the random sample is free from selection bias.

4.3 Recipients will collaborate with CDC to propose and employ separate patient interview methodologies for each of the two (2) investigation periods (examples include traditional DIS follow-up, SMS text messaging, secure on-line survey with unique ID code, phone-based survey app, etc.). The purpose of this requirement is to evaluate the relative merits and costs of different methods of patient contact; process information on contact methods and outcomes will be evaluated locally, documented and reported with aggregate results to CDC. Additional guidance will be provided to successful applicants for this focus activity post-award.

Expected outputs:

a) Dataset of all reported chlamydia cases in the specified area with unique patient, case and provider IDs, HIV match results, and investigations for randomly sampled cases -transmitted per protocol to CDC at the conclusion of each investigation period

Activity 5: Enhanced cases investigations among early syphilis cases reporting neuro, ocular and otic symptoms

5.1 Following revised SSuN protocols (https://www.cdc.gov/std/funding/ssun/default.htm), recipients will conduct enhanced provider and patient follow-up on early syphilis cases to identify signs and symptoms of neuro, otic, or ocular syphilis as well as treatment provided and results of any clinical evaluations.

Expected outputs:

a) Dataset of adult syphilis cases with unique patient, case and provider IDs, HIV match results, provider and patient investigations - transmitted per protocol to CDC

Activity 6: Syndromic surveillance for neuro, ocular and otic signs/symptoms to detect undiagnosed syphilis

6.1 Recipients will collaborate with CDC to propose and conduct active surveillance projects in a high volume ED, ophthalmology, neurology or other appropriate clinical facility in their jurisdiction designed to apply a syndromic surveillance case definition to potentially identify patients with neuro, ocular or otic symptoms not otherwise explained by other underlying causes for follow-up testing and evaluation for syphilis. This activity must involve the active participation of an appropriate clinical partner. This partner, and rationale for the choice of this facility must be fully described in the proposal. Recipients of funding for this focus activity will collaborate with CDC in the creation of the surveillance case definition, monitor project implementation in the clinical setting and to design and conduct evaluation of the project.

Expected outputs:

a) Documentation of case definition and unique patient records queried - aggregate results summarized and transmitted per protocol to CDC

Activity 7: Implementation of HL7 case reporting through NNDSS

7.1 Recipients will collaborate with CDC to implement STD and congenital syphilis (CS) message mapping guides (MMGs) and complete the transition to HL7-based case reporting to CDC though the National Notifiable Diseases Surveillance System (NNDSS) Modernization Initiative (NMI). Additional information on NMI and the STD and CS

MMG requirements can be found at https://www.cdc.gov/nmi/index.html.

7.2 Recipients funded for this focus activity will work with the Center for Surveillance, Epidemiology and Laboratory Science (CSELS) at CDC to begin the on-boarding process and agree to implement STD and CS message mapping guides for routine reporting of STD cases to CDC through NNDSS.

Expected outputs:

a) Implementation package showing NNDSS data cross-walk and HL7 mappings -transmitted per protocol to CDC/CSELS

b) HL7 test records transmitted per protocol to CDC/CSELS

c) Limited production HL7 messages transmitted per protocol to CDC/CSELS

d) Year-to-date matching datasets in both NETSS and HL7 formats transmitted per protocol to CDC/CSELS

e) Cut-over to HL7 production for reporting of STDs to CDC through NNDSS

Activity 8: Technical assistance to STD-PCHD recipients implementing enhanced gonorrhea investigations

8.1 Recipients funded for this focus activity will work with CDC SSuN and Program Development and Quality Improvement Branch (PDQIB) staff to identify technical assistance needs in neighboring jurisdictions, design curricula and provide direct peer-to-peer assistance (facilitated through webinar, conference call, materials sharing and [infrequently] through site visit) to health departments implementing limited enhanced gonorrhea activities funded under STD-PCHD.

Expected outputs:

a) Documentation of technical assistance needs, gaps identified, communications and technical assistance plans, summary results.

Activity 9: Surveillance Focus activities of local interest

9.1 Recipients will propose and collaborate with CDC to implement a locally relevant focus activity designed to implement activities that address issues pertinent to improving/enhancing local STD surveillance capacity, efficiency, timeliness, completeness, representativeness of surveillance data and/or to analyze, interpret and disseminate STD surveillance data to relevant stakeholders in innovative, impactful ways. In collaboration with CDC, recipients will evaluate, document and disseminate findings of the activity.

Overarching Activities Relevant to All Strategies

10.1 Recipients are required to participate in regularly scheduled conference calls, virtual meetings, interviewer trainings, requests from CDC for technical assistance for STD-PCHD (PS19-1901) recipients and annual face-to-face recipient meetings (a minimum of 2 key staff should attend from each funded area) as required by CDC to review protocols, refine best practices, report progress toward meeting SSuN objectives, present preliminary data and describe status of all ongoing activities.

https://www.cdc.gov/nmi/index.html

10.2 Recipients are assumed to have sufficiently robust local information systems necessary for the collection, management, integration, analysis, and transmission of all project data. Any minor local data system modifications necessary for data management of case investigation data, clinic visit and related data, and processes/systems for collection and data entry of clinic survey data must be completed and data collection activities initiated in a timely manner in the first year of funding.

10.3 Recipients will assure that data management methods and information systems supporting these activities provide efficient, sustainable, routine, automated and well-documented processes in order to limit staff burden and minimize the effect of unanticipated staff turnover.

10.4 Recipients will demonstrate willingness and capacity to provide meaningful resources and technical assistance to STD clinics providing data to assure ongoing extraction, appropriate transformation, transmission, validation/quality assurance, and data management of all required data. Meaningful resources may include direct assistance through staff time or financial support to the data-providing entity through subcontracts or other local mechanisms.

10.5 Recipients must be willing to work collaboratively with CDC and other funded project areas to assure protocols and data elements for SSuN activities are fully implemented and maintained across all funded strategies and activities. Recipient inability to initiate or to maintain data collection activities in full compliance with protocols, and with appropriate data quality assurance, may affect future support.

10.6 'Jurisdiction' for the purposes of this NOFO is defined as the entire geographic extent of the funded agency's administrative boundaries. For state governments, this includes all counties and cities in that state regardless of independent funding status. For city or county health departments independently funded by CDC under PS19-1901, this includes whole or partial counties within that health department's entire administrative catchment area. For city or county health department applicants not independently funded by CDC under PS19- 1901 (STD-PCHD), formal proxy authority for access to HIV/STD surveillance data must be obtained from the appropriate state health agency funded through PS19-1901 (STD- PCHD) and clearly documented through attachment(s). City or county health department applicants (regardless of independent funding status under PS19-1901), in consultation with state health department STD programs, may propose to conduct activities in broader geographic areas. The geographic extent must be specified and formal proxy authority for access to HIV/STD surveillance data throughout the entire geographic area proposed must be documented. Name the file 'Proxy' and upload it as a PDF file at www.grants.gov. All recipients must implement Strategy B activities within their entire jurisdiction or proposed geographic area, and may choose to include STD-specific clinical facilities for Strategy A activities from any location within their jurisdiction or proposed geographic area.

Preference should be given to those facilities that are considered most representative of at-risk populations in the jurisdiction. Geographic extent of all proposed activities must be fully documented in the application.

10.7 Recipients must use findings and methods from their SSuN activities to improve and enhance existing STD (or STD/HIV, if integrated) surveillance capacity in their jurisdictions and assure that SSuN activities are fully integrated into surveillance activities http://www.grants.gov/ funded under PS19-1901 (STD-PCHD). Recipients are required to conduct surveillance evaluation activities as a requirement of Strategy B (see above) and to fulfill the Applicant Evaluation and Performance Measurement Plan; these should be conducted in collaboration with CDC and with state/local STD program staff; findings must be formally documented and applied to improving overall STD surveillance capacity in the recipient's jurisdiction.

10.8 Recipients will develop methods to incorporate efficiencies achieved in the course of SSuN efforts, with respect to data systems and electronic lab/case data, into routine surveillance practice. Applicants are strongly encouraged to integrate resources and activities within STD (or STD/HIV, if integrated) surveillance and program units.

10.9 Recipients are required to create formal, ongoing collaborative processes…