Foa_Content_of_CDC-RFA-PS-24-0082.pdf

Centers for Disease Control and Prevention

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

Sexually Transmitted Infection Surveillance Network (SSuN) Cycle 5

CDC-RFA-PS-24-0082

05/15/2024

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA-PS- 24-0082. 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:

Sexually Transmitted Infection Surveillance Network (SSuN) Cycle 5

C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS-24-0082

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.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

E. Assistance Listings Number:

93.977

F. Dates:

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

04/01/2024

2. Due Date for Applications:

05/15/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

Two identical informational webinars will be hosted:

1. March 12, 2024, 9:00-10:00am, EST: https://cdc.zoomgov.com/meeting/register/vJItf- 6hrDwoHPMDngA1rUSVYdedNzG0FHI

2. March 14, 2024, 3:30-4:30pm, EST:

https://cdc.zoomgov.com/meeting/register/vJItceGorD8jEqm0uYInyVM9n_y3HT3Ikac

G. Executive Summary:

1. Summary Paragraph CDC announces availability of fiscal year 2024 funding for cooperative agreements for Cycle 5 of the STI Surveillance Network (SSuN). Continuing resurgence of STIs, along with the imperative to implement syndemic approaches to surveillance addressing related epidemics such as HIV and mpox inform this competitive Notice of Funding Opportunity (NOFO), which will support sentinel and enhanced surveillance at the local, state, and national level. Emergent issues of concern such as mpox add urgency to the maintenance of robust surveillance at the community level and in sexual health clinical settings. This NOFO supports two core and one supplemental strategy. Strategy A supports sentinel surveillance in sexual health clinical facilities, Strategy B implements enhanced surveillance for STIs reported to health departments and Strategy C supports limited supplemental projects. Both core strategies (A & B) integrate a syndemic approach to monitoring STIs, HIV, behavioral data, and preventive services accessed by persons presenting for care in sexual health settings, and persons diagnosed and reported with selected STIs from all provider settings in defined geographic areas. The goal of this NOFO is to monitor trends in patient characteristics, screening, and diagnoses to identify opportunities and gaps across the STI/HIV prevention continuum. Protocols address information gaps in routine case reporting and incorporate local flexibility to respond to emergent health issues.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$40,000,000 https://www.grants.gov/ https://cdc.zoomgov.com/meeting/register/vJItf-6hrDwoHPMDngA1rUSVYdedNzG0FHI https://cdc.zoomgov.com/meeting/register/vJItf-6hrDwoHPMDngA1rUSVYdedNzG0FHI https://cdc.zoomgov.com/meeting/register/vJItceGorD8jEqm0uYInyVM9n_y3HT3Ikac

Up to $40,000,000; contingent on the availability of federal funding.

e. Average One Year Award Amount:

$266,666 Range of individual awards: $130,000 to $720,000 per award depending on patient census, morbidity levels, specific strategies proposed and number of STI/Sexual Health clinics included.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

August 15, 2024

h. Cost Sharing and / or Matching Requirements:

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

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview In 2022, more than 2.5 million cases of syphilis, gonorrhea and chlamydia were reported to CDC representing an increase of 1.9% since 2018. Considering interruptions to sexual health care services related to the COVID-19 pandemic, this increase in reported cases may underestimate the true burden of disease as many infections are asymptomatic and may never be diagnosed and reported to public health authorities. Sexually transmitted infections (STIs) can have long-term health consequences, especially regarding reproductive health. Rates of congenital syphilis continue to surge with over 3,700 cases reported in 2022, an increase of over 900% in the last decade (1-3). STIs represent a significant economic drain on the U.S. healthcare system, with annual costs estimated to be nearly $16 billion in 2018 (4).

Moreover, persons at risk for or diagnosed with bacterial STIs are at increased risk for acquisition or transmission of HIV, representing overlapping populations essential to national efforts to end the HIV epidemic (5). Successful STI surveillance programs must also recognize the syndemics that affect the people and places disproportionately affected by these infections.

Recent emergence and global spread of mpox (6) through overlapping, global sexual networks highlight the importance of improving the surveillance infrastructure for monitoring population-level incidence of STIs, ascertainment of demographic and behavioral characteristics of persons being diagnosed with STIs, and the prevalence of co-infections. It is especially important to systematically measure the uptake of important biomedical interventions such as Pre-Exposure Prophylaxis (PrEP) for HIV, preventive vaccinations for mpox and other viral infections such as Human Papilloma Virus (HPV) and the viral hepatidities, antimicrobial treatments, and the use of post-exposure antibiotic prophylaxis to prevent bacterial STIs.

Significant inequities in the burden of STIs in the U.S., including differential access to and utilization of preventive services by racial, ethnic and gender/sexual minority populations (GSM), have also been documented (7). Additional demographic, socioeconomic, and behavioral information on patients presenting for care and for persons diagnosed and reported with STIs is needed to better characterize the extent of these disparities and to inform timely efforts to ensure equitable sexual health outcomes across all U.S. populations.

This new, competitive NOFO builds upon and expands, participation in a geographically diverse network of clinical and public health partners implementing syndemic approaches to enhanced and sentinel STI surveillance. This approach recognizes that disease risks cross-cut multiple diseases and conditions, as well as the social contexts in which they occur, often resulting in worse outcomes such as increased transmission, morbidity, and exacerbation of existing health inequities. Data obtained through this surveillance initiative are critical to understanding changing risk patterns, detecting emergent, re-emergent or novel infections and sequela, and informing both local and national STI/HIV control and prevention efforts. This NOFO also seeks to maximize the synergies offered through Ending the HIV Epidemic in the US (EHE) and to provide substantial integration with respect to surveillance activities in sexual health clinical settings to better characterize patient-level co-factors that may facilitate, or present barriers to, the uptake of HIV prevention interventions such as HIV PrEP.

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 2030 This project addresses the “Healthy People 2030” topic area of Sexually Transmitted Diseases:

https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections, https://health.gov/healthypeople, also addresses the priority areas of Health Equity and the Social Determinants of Health and objectives related to LGBTQ+ (https://health.gov/healthypeople/objectives-and-data/browse-objectives/lgbt) population health, improving health care (https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care), and Public Health Infrastructure (https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure).

d. Other National Public Health Priorities and Strategies This project is responsive to the following priorities:

STI National Strategic Plan (https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html), NCHHSTP Strategic Plan (https://www.cdc.gov/nchhstp/strategicpriorities/default.htm)

Division of STD Prevention 2022 – 2026 Strategic Plan: (Division of STD Prevention Strategic Plan 2022-2026)

National Strategy for Combating Antibiotic-Resistant Bacteria (https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf), National HIV/AIDS Strategy (https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/), https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://health.gov/healthypeople, https://health.gov/healthypeople/objectives-and-data/browse-objectives/lgbt https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.cdc.gov/nchhstp/strategicpriorities/default.htm https://www.cdc.gov/std/dstdp/dstdp-strategic-plan-2022-2026.htm https://www.cdc.gov/std/dstdp/dstdp-strategic-plan-2022-2026.htm https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/ https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/

Ending the HIV Epidemic in the U.S. (https://www.cdc.gov/endhiv/index.html).

e. Relevant Work This NOFO expands and builds on the foundation of sentinel and enhanced surveillance currently funded under CDC-RFA-PS19-1907 (STD Surveillance Network), programmatic activities funded under CDC-RFA-PS20-2010 (Ending the HIV Epidemic, EHE), PS18-1802 (Integrating HIV Surveillance and Prevention Programs for Health Departments) and CDC-RFA- PS19-1901 (STD Prevention and Control for Health Departments). Additional work under CDC- RFA-TP22-2201 Public Health Crisis Response Cooperative Agreement for mpox also informs this current funding opportunity.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes Long-Term Outcomes

(A) Protocol-based sentinel surveillance in STI/Sexual Health Clinics:

1. Systematic abstraction of patient and visit-level data from electronic health records (EHRs)

2. Systematic abstraction of diagnoses, treatments, vaccinations, prophylaxis, and laboratory data from EHRs

3. Periodic patient surveys

4. Routine, frequent

(1.1) Improved ascertainment of patient characteristics, STI/HIV-risk and repeat infections

(1.2) Improved ascertainment of patient-level eligibility for and uptake of STI/HIV/mpox preventive services

(1.3) Improved timeliness, data completeness and data quality

(1.4) Timely availability of findings informing

(2.1) Increased data-driven, evidence-based public health action

(2.2) Timely, comprehensive ascertainment of HIV/STI/mpox specific clinical and preventive services in STI/Sexual Health clinical settings

(2.3) Improved understanding of barriers to preventive STI services, sexual health clinical care and provider-based HIV and STI prevention interventions

(2.4) Improved ascertainment of adverse outcomes and negative

(3.1) Improved quality of care in STI/Sexual Health clinical care settings

(3.2) Improved provider compliance with STI/HIV/mpox screening, preventive services, and CDC treatment guidelines

(3.3) Improved patient access to preventive STI services, sexual health clinical care and provider-based HIV and STI prevention https://www.cdc.gov/endhiv/index.html patient-based matching with state

HIV

surveillance records

(B) Protocol-based enhanced case-based STI surveillance:

1. Systematic collection of enhanced data elements for a full census of reported cases

2. Enhanced case investigations

3. Routine case-based matching with state

HIV

surveillance records.

4. Provision of technical assistance to state and local STI surveillance and program staff in monitoring and improving

STI

surveillance data quality

STI/HIV/mpox control and prevention policy

(1.5) Quarterly data quality reporting

(1.6) Increased understanding of STI surveillance data by provider, health department and community stakeholders through dissemination of findings in relevant journals, reports, publications, and conferences sequela of STIs by STI Programs and Clinics

(2.5) Improved ascertainment of prescribed/administered treatment(s)

(2.6) Improved awareness of disease burden by relevant patient characteristics in community settings

(2.7) Improved availability of information on trends in HIV status, HIV care, PrEP, doxy PEP, MenB & mpox vaccination among STI cases diagnosed in community settings

(2.8) Improved STI surveillance systems and methods

(3.4) Improved evidence for developing recommendations, guidelines, and best practices for STI surveillance

(3.5) Decreased disease incidence and morbidity associated with STI/HIV/mpox i.

Purpose The purpose of this NOFO is to support sentinel and enhanced surveillance for STIs providing complete demographics, behavioral risk, clinical and preventive services data missing in routine case reporting or not available from other sources. Surveillance activities funded by this NOFO provide epidemiologic and preventive services information filling gaps in knowledge regarding STI/HIV prevention priorities. These data improve the ability of public health agencies to address STI/HIV health equity outcomes, emergent threats and syndemic interactions in populations with shared risks.

ii. Outcomes Recipients of funding under CDC-RFA-PS-24-0082 are expected to demonstrate full implementation of data collection, data cleaning, data transmission and related output activities in compliance with project protocols in order to address the outcomes appearing in bold in the logic model. Datasets constitute the primary outputs supporting achievement of these outcomes and must be routinely and securely transmitted to CDC at specified intervals and in specified formats in compliance with data submission schedules.

Expected outcomes by component Strategy include:

Strategy A: (Protocol-based sentinel surveillance in collaborating STI/Sexual Health Clinics)

• Improved, timely ascertainment of patient characteristics, clinical services, diagnoses, laboratory testing, treatments prescribed/provided to patients.

• Improved, timely ascertainment of HIV, STI and mpox preventive services delivered to patients (e.g., HIV PrEP/ PEP, Doxycline Post Exposure Prophylaxis[doxy PEP], mpox, Meningococcal B (MenB) and other relevant vaccinations such as HPV and the viral hepatidities).

• Improved provider compliance with screening, treatment, and preventive service recommendations through timely ascertainment and reporting of patient outcomes.

• Improved timeliness, data completeness and data quality through continuous quality assurance activities.

• Improved ability to understand health equity outcomes across multiple demographic and behavioral groups through timely ascertainment and analyses of patient characteristics and outcomes.

Strategy B: (Protocol-based enhanced STI case surveillance in defined geographic areas)

(C) Surveillance Focus Activities:

Short-term activities to evaluate methods, monitor STI/HIV testing, diagnosis, treatment, sequelae, and eligibility/uptake of HIV-prevention

• Improved, timely ascertainment of reported cases of gonorrhea and syphilis.

• Improved ability to estimate patient demographic characteristics, behavioral risk, treatment, and access to (and use of) preventive services through enhanced investigations on a representative sample of reported cases.

• Improved, timely information on HIV co-infection and trends among diagnosed and reported gonorrhea and syphilis cases.

• Improved, timely information on HIV and mpox-related preventive services delivered to persons diagnosed and reported with gonorrhea and/or syphilis.

• Improved provider and community-level compliance with gonorrhea and syphilis treatment recommendations.

• Improved ability to understand community-wide health equity issues across multiple demographic and behavioral groups through timely ascertainment and analyses of patient characteristics and outcomes.

• Improved timeliness, data completeness and data quality through continuous quality assurance activities

Strategy (C): Surveillance Focus Activities

These shorter-duration, limited-scope activities are designed to improve quality and utility of surveillance data and to pilot methods for monitoring the burden of disease, cost, and adverse health outcomes across a range of STIs and laboratory and provider settings. Eligible applicants should also apply for one or more Strategy C activities relevant to the core activities they are proposing in their application (Strategy A or B separately, or both strategies in combination).

Strategy C activities may be awarded if funds are available for the initial budget period.

Examples of anticipated/potential outcome and outputs include:

• Improved ability to ascertain and respond to emergent issues of concern in STI surveillance.

• Improved ability to ascertain co-factors affecting access to (and use of) preventive services.

• Enhanced ability to assess, visualize and report on community-level trends in gonorrhea and syphilis diagnosis and treatment using data obtained from enhanced investigations on a representative sample of reported cases.

• Improved ability to integrate, manage, de-duplicate, visualize, interpret and rapidly report on trends in STI-related laboratory and case data using local surveillance data management systems.

• Improved programmatic outcomes through comprehensive evaluation efforts.

• Documented EHR/EMR system requirements and implementation plan.

• Documented EHR/EMR system modifications, datasets, data entry screens, and/or reports.

• Quarterly reporting/monitoring of proportion of eligible patients referred to, initiating, and maintaining HIV PrEP (or dPEP).

• Quarterly reporting/monitoring of proportion of HIV PrEP/doxy PEP users screened for

STIs in compliance with guidelines.

• Quarterly reporting/monitoring of proportion of HIV PrEP/doxy PEP users diagnosed with STI(s).

• Quarterly reporting/monitoring of proportion of HIV PrEP/doxy PEP users maintaining HIV PrEP/doxy PEP at quarterly intervals.

• Quarterly reporting/monitoring of proportion of HIV PrEP/doxy PEP users lost to follow-up at quarterly intervals.

• Documented system requirements for adherence support platform and implementation plan.

• Proportion of HIV PrEP patients enrolling and actively using adherence support platform.

• Evaluation of the adherence support platform’s user (patient) acceptability and effectiveness.

• Comprehensive analysis of co-factors facilitating HIV PrEP uptake and maintenance.

• Comprehensive analysis of co-factors inhibiting HIV PrEP uptake and maintenance.

• Programmatic recommendations for enhancing HIV PrEP uptake and maintenance among sex and gender minorities and women of color.

• Implementation and evaluation of CDC-provided syphilis automated record search and review algorithm.

• Evaluation of surveillance case definitions for neonatal HSV.

• Peer-reviewed publication(s) or conference presentation(s) based substantially on multi-site SSuN data.

iii. Strategies and Activities Strategy A – Protocol-based sentinel surveillance in STI/Sexual Health Clinics

All recipients funded for Strategy A of the STI Surveillance Network are required to fully implement sentinel surveillance data abstraction, data collection, data cleaning/formatting, and transmission of data to CDC from one or more specialty STI/Sexual Health clinics in compliance with project protocols (https://www.cdc.gov/std/ssun/default.htm) as described below.

For the purposes of this NOFO, STI/Sexual Health clinics are defined as any clinical facility providing timely, comprehensive, confidential, and culturally sensitive STI care as the facility’s advertised and usual function, including HIV testing, STI testing at relevant anatomical sites, timely STI treatment (benzathine penicillin LA, and ceftriaxone) and provision of, or referral to, recommended vaccinations (i.e., Hepatitis A and B, Human Papilloma Virus[HPV], mpox).

Clinics need not be stand-alone and may be integrated into broader practice settings or may be part of a network with multiple facilities. However, the selected facility must have a specifically identifiable STI/Sexual Health clinic with an annual patient census greater than 2,000 unique patients per facility and have the capacity to identify and extract visit, laboratory, diagnosis, and treatment records from their electronic health records system(s) just for those patients specifically seeking STI/Sexual Health clinical services distinct from their broader patient population.

All Strategy A recipients will be required to prepare and securely transmit to CDC four (4) related datasets six (6) times annually (every two months) as described in Table 1 below in compliance with project protocols. Additionally, all Strategy A recipients are required to collaborate with the appropriate HIV surveillance authority to conduct periodic matches of all individual patients presenting for care in their proposed clinic against their jurisdiction’s official HIV surveillance registry to assist in determining the clinic’s HIV coinfection rate and the disease status of patients as described in 3.a-b below. Clinics do not necessarily need to have an https://www.cdc.gov/std/ssun/default.htm administrative relationship with health departments for HIV registry matching collaboration;

they may be independent entities but must be willing to provide name-identified patient information to the appropriate HIV surveillance authority for registry matching purposes and document this intention with an MOU/MOA with the HIV surveillance unit. Registry matching must be fully implemented within the initial budget period.

1. Systematic abstraction of patient and visit-level data from electronic health records (EHRs)

a. Recipients must identify one or more STI/Sexual Health clinic(s) in their jurisdiction as collaborating partners in sentinel surveillance activities and provide metadata for each clinic documenting policies and current practices for STI screening, STI treatment, doxy PEP, HIV testing, HIV PrEP/PEP initiation, monitoring and/or referral. Where multiple facilities, either in a network or stand-alone, are contributing data to Strategy A, a unique metadata record will be submitted for each separate facility/clinic in specified formats. Metadata for all clinics will be updated annually.

b. Recipients must abstract visit-level clinical records for all persons receiving STI/HIV or sexual health services in the collaborating STI/Sexual Health clinics, including all data elements specified in project protocols. Static patient IDs are required and must be preserved throughout the project period. If the applicant is a current (SSuN Cycle 4) recipient, static patient IDs must be maintained between cycles. Recipients will abstract all data elements specified in project protocols including clinical information, data on patient demographics (age, sex, race/ethnicity, sexual orientation, gender identity, etc.), behaviors (gender and number of sex partners, etc.) and preventive services received (provision of dPEP, HIV PrEP/PEP, mpox vaccinations, etc.).

2. Systematic abstraction of diagnoses, treatments, vaccinations, prophylaxis, and laboratory data from EHRs

a. Recipients must abstract in a separate, relational file all STI-related laboratory records associated with each unique clinic visit record, including relevant test types, condition tested, specimen type, anatomic site, collection date, and results (qualitative and quantitative) in formats specified in project protocols.

b. Recipients must abstract in a separate, relational file all diagnoses associated with each unique visit, including all diagnosis-related data elements, diseases and conditions in formats specified in project protocols.

c. Recipients must abstract in a separate, relational file all treatment records associated with each unique visit, including relevant medications/vaccines administered or prescribed, date medication was prescribed/administered method of administration, and dosing schedule (e.g., dosage(s), frequency, and duration) in formats specified in project protocols.

3. Periodic patient surveys

a. Recipients must establish an infrastructure to implement periodic patient surveys at the time of service (e.g., in the waiting room or upon registration)

4. Routine, frequent patient-based matching with state HIV surveillance records

a. Recipients must collaborate with the appropriate local or state HIV surveillance authority to routinely match all patients (regardless of presence or lack of STI or other diagnoses) seen in the clinic against the jurisdiction’s HIV case registry (such as the HIV/AIDS Reporting System [eHARS] or similar local, comprehensive HIV case registry). Where person-based matches are established, relevant HIV-related diagnostic and laboratory data (HIV viral loads and CD4+ lymphocyte counts/percents) will be abstracted from HIV surveillance registries and integrated into required visit (A.2) and laboratory datasets (A.3) in formats specified in project protocols. Laboratory records for HIV-specific tests (obtained from the HIV registry) for matching patients are requested for all tests with a specimen collection date for a period of one year prior to the patient’s most recent date of visit to the STI clinic.

b. In collaboration with the relevant health department’s HIV Overall Responsible Party (ORP), recipients must ensure that patient name-based identifiers are replaced in all archived datasets with non-name-based unique identifiers;

personally identifiable information (PII) must be redacted from datasets prior to transmission to CDC.

Required Activities Supporting Strategy A Implementation:

a. Recipients must ensure timely and prompt data quality assurance, including recoding source data into required formats, application of CDC-provided edit and data validity checks to datasets and must address all identified data quality issues prior to secure transmission of all required datasets to CDC following protocols and data transmission schedules.

b. Recipients must be responsive to CDC-provided quality assurance feedback and attempt to correct local records or recoding processes when errors, missing data and/or data validity issues are identified, either through routine reporting or in response to specific analytic priorities.

c. Recipients must ensure that measures, methods, and processes are developed and implemented within the first budget period to provide for timely local analysis, visualization, reporting and dissemination of findings to relevant clinical, health department and community stakeholders.

d. STI/Sexual Health Clinical facilities receiving SSuN Strategy A funding that are also funded under CDC-RFA-PS-24-0003 (Support and Scale Up of HIV Prevention Services in Sexual Health Clinics) are required to continue to submit aggregate performance measures required under CDC-RFA-PS-24-0003 until such time as their Strategy A data have been formally validated by CDC. Once Strategy A data have been validated for a participating facility, CDC will notify the recipient and assume responsibility for producing and submitting aggregate reports (for overlapping SSuN data elements) for CDC-RFA-PS-24-0003 as part of an effort to reduce the reporting burden on clinics funded under both initiatives.

e. Proposals for multi-site analyses, especially those focusing on health equity in HIV/STI preventive services relating to HIV PrEP/PEP, HIV testing and doxy PEP, will be periodically solicited and sent to Strategy A principal investigators for their consideration. Dissemination of findings is a key component of successful surveillance activities. Recipients of Strategy A funding are required to promptly review analytic proposals and indicate their preference for inclusion of their clinic’s data as well as indicate willingness to participate as a co-author in SSuN multi-site analytic projects.

Local clearance of resulting manuscripts will be concurrent with submission to CDC clearance. These analyses generally lead to publication in an STI-related academic and/or professional journal or as reviewed abstracts for oral or poster presentations at relevant public health conferences.

f. Recipients of Strategy A funding (Principal Investigators and key staff) are required to participate in routine, monthly project conference calls with CDC project staff and to support travel for 2-3 project representatives (Principal Investigators and key staff) to attend annual SSuN Principal Investigator’s meetings in Atlanta.

Table 1: Datasets required to be abstracted from clinic sources, re-coded, and securely transmitted routinely to CDC by recipients of funding under SSuN Strategy A

Strategy A Dataset(s) Record Contents Frequency of

Submission

1 - Clinic Visit Records

Line-listed, visit-level data that includes demographics, behavioral, and clinical information consistent with protocol, cumulative from the beginning of the calendar year

Every 2 months

2 - Clinic Laboratory Records

Line-listed STI-related laboratory tests associated with each patient visit in a separate record, consistent with protocol and cumulative from the beginning of the calendar year

Every 2 months

3 - Clinic Diagnosis Records

Line-listed STI-related diagnoses associated with each visit in a separate record, consistent with protocol and cumulative from the beginning of the calendar year

Every 2 months

4 - Clinic Treatment Records

Line-listed medications, vaccines, treatments prescribed, dispensed or administered at each visit in a separate record, consistent with protocol and cumulative from the beginning of the calendar year

Every 2 months

5 - Clinic metadata file

Descripting/services/policy information for each clinic consistent with protocol for that calendar year in separate record

Initial submission, updated annually thereafter

Year-End Datasets (1-5)

Final, cleaned and validated annual cumulative datasets consistent with protocol and containing all records for the previous calendar year. These serve as the primary analytic data.

Due March 15th of each year of the cooperative agreement

Strategy B – Protocol-based enhanced case-based STI surveillance:

All recipients funded for Strategy B of the STI Surveillance Network are required to fully implement enhanced case-based surveillance, case sampling, provider and patient enhanced investigations, HIV registry matching, data cleaning/formatting, and transmission activities in compliance with project protocols (https://www.cdc.gov/std/ssun/default.htm) for reported cases of gonorrhea and syphilis (all stages) as described below.

All Strategy B recipients are required to prepare and securely transmit to CDC three (3) related datasets six (6) times annually (every two months) as described in Table 2 below in compliance with project protocols. Additionally, all Strategy B recipients are required to collaborate with the appropriate local or state HIV surveillance authority to match individual patients reported with gonorrhea and syphilis (all stages) against their jurisdiction’s official HIV surveillance registry to assist in determining HIV prevalence among reported cases and the disease status of individual cases as described below.

1. Systematic collection of enhanced data elements for a full census of reported cases

a. Recipients must implement processes to rapidly identify a random, probability sample of STI cases (gonorrhea and early syphilis cases [primary, secondary, and non-primary/non-secondary cases) reported among residents of their jurisdiction.

These processes must allow the flexibility to periodically vary the sampling fraction independently between diseases and geographic sub-units (i.e., counties, if applicable) in their jurisdiction.

b. Recipients will collaborate with CDC to conduct routine assessments of their probability sampling method by disease and by geography to ensure that there are no systematic sampling biases and to ensure 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, this should be documented in data submitted in compliance with protocols.

c. Recipients must extract, recode, format, and transmit all reported case records from their STI surveillance data management system for all cases of gonorrhea and 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 selection assignment, and all other required data elements per CDC protocols and in appropriate formats and file structures as specified in project protocols. Cumulative case datasets will be extracted and transmitted to CDC at 2-month intervals (6x annually).

d. Recipients must extract, recode, format, and transmit all available treatment information associated with each reported gonorrhea or syphilis cases in a dataset related to the case record dataset through event IDs. Cumulative treatment datasets will be extracted and transmitted to CDC at 2-month intervals (6x annually).

e. The minimum sample size for gonorrhea and syphilis cases should be determined based on overall morbidity reported in the jurisdiction and adjusted by anticipated interview completion rates to result in fully completed case investigations for no less than 2% of the overall total of all cases reported. For example, if there are 10,000 reported gonorrhea cases, the minimum target for cases with fully completed investigations would be 200. Assuming an investigation completion https://www.cdc.gov/std/ssun/default.htm rate of 65% of all cases initiated, the total number of gonorrhea cases that need to be sampled would be 308 (a sample fraction of 3.08%). Investigation completion rates can vary substantially over time and across the project area. Recipients should begin with an initially higher sample fraction and adjust over time to reflect local disease trends, investigative capacity, and other relevant factors.

2. Enhanced case investigations

a. Recipients must conduct internal, look-back investigations using existing health department records (surveillance registries, electronic laboratory records, etc.) for all gonorrhea and early syphilis cases (primary, secondary, and non-primary/non-secondary early syphilis cases) in compliance with CDC protocols; these investigations ensure de-duplication of persons and cases, obtain history of previous STI/HIV diagnoses and obtain additional information that may be present in existing surveillance records to assist in patient and/or provider investigations.

b. For gonorrhea and early syphilis cases (primary, secondary, and non-primary/non-secondary early syphilis cases) identified in the random sample, recipients must conduct provider investigations in compliance with SSuN protocols. Provider investigations with the diagnosing/reporting provider or facility will include verification and ascertainment of gonorrhea and/or syphilis treatment (drugs & doses), signs/symptoms, clinical manifestations of infection such as Disseminated Gonococcal Infection (DGI), indications of otic, ocular and neurosyphilis, all anatomic site(s) of infection for gonorrhea, screening by anatomic site, insurance status, preventive services, HIV status, HIV testing, pregnancy status, provision of doxy PEP, and to obtain additional contact information from the provider to assist in contacting patients for interview. Methods for provider investigations 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 to achieve a provider investigation completion rate of 65% or greater of all cases identified in the random sample.

c. Recipients must attempt to interview all gonorrhea and early syphilis cases (primary, secondary, and non-primary/non-secondary early syphilis cases) reported throughout their jurisdiction that are in the random sample in compliance with project protocols. At least 4 attempts at patient contact are required and may be comprised of different methods (SMS, voice call, field visit, US mail, etc.).

Methods and outcomes of each contact attempt must be fully documented before closing the case record as ‘unable to contact’. If local partner services (PS) investigations are initiated for syphilis cases, every attempt should be made to incorporate SSuN data elements into the PS case investigations and to de-conflict processes to prevent multiple patient contacts.

d. Recipients must ensure that adequate, trained staff resources are available to conduct enhanced case investigations for the anticipated volume of cases sampled throughout the geographic extent of their proposed project area.

e. Recipients must ensure that interview attempts can be initiated and/or patient call-backs can occur during some 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 and emergency contact information, and other available methods. Patient interviews for SSuN enhanced case investigations may be conducted by telephone or in-person following local health department procedures for contacting and confirming the identity of patients during routine partner services investigations.

3. Routine case-based matching with state HIV surveillance records.

a. Recipients must collaborate with the appropriate local or state HIV surveillance authority to routinely match all reported gonorrhea and syphilis cases against the jurisdiction’s HIV case registry (such as eHARS or similar local, comprehensive HIV case registry). Where person-based matches are established, relevant HIV-related diagnostic and laboratory data (HIV viral load, CD4+) will be abstracted from HIV surveillance registries and integrated into required case (B.3) and laboratory datasets (B.5) in formats specified in project protocols. Laboratory records for HIV-specific tests (obtained from the HIV registry) for matching patients are requested for all tests with a specimen collection date for a period of one year prior to the diagnosis (or report) date of the case.

b. In collaboration with the relevant health department’s HIV Overall Responsible Party (ORP), recipients must ensure that patient name-based identifiers are replaced in all archived datasets with non-name-based unique identifiers;

personally identifiable information (PII) must be redacted from all datasets prior to transmission to CDC.

4. Provision of technical assistance to state and local STI surveillance and program staff in monitoring and improving STI surveillance data quality

a. Dissemination of findings is a key component of successful surveillance activities. Recipients of Strategy B funding are required to review, analyze, visualize, interpret, and report locally on Strategy B findings to enhance and improve STI surveillance capacity and enhance local STI prevention and control activities.

Required Activities Supporting Strategy B Implementation:

a. Recipients must be responsive to CDC-provided quality assurance feedback and attempt to correct local records or recoding processes when errors, missing data and/or data validity issues are identified, either through routine reporting or in response to specific analytic priorities.

b. Proposals for multi-site analyses, especially those focusing on health equity in HIV/STI preventive services relating to HIV PrEP/PEP, HIV testing and doxy PEP, as well as demographic, clinical and behavioral trends in reported cases will be periodically solicited and sent to Strategy B principal investigators for their consideration.

Dissemination of findings is a key component of successful surveillance activities.

Recipients of Strategy B funding are required to promptly review analytic proposals and indicate their preference for inclusion of their jurisdiction's data as well as indicate willingness to participate as a co-author in SSuN multi-site analytic projects. Local clearance of resulting manuscripts will be concurrent with submission to CDC clearance.

These analyses generally lead to publication in an STI-related academic and/or professional journal or as reviewed abstracts for oral or poster presentations at relevant public health conferences.

c. Recipients of Strategy B funding are required to participate in routine, monthly project conference calls with CDC project staff and to support travel for local project representative(s) to attend annual SSuN Principal Investigators' meetings in Atlanta.

Table 2: Datasets required to be abstracted from health department surveillance, electronic laboratory, or other record systems, recoded, and securely transmitted to CDC by recipients of funding under SSuN Strategy B

Strategy B Dataset(s) Record Contents Frequency of

Submission

1 - Case Records

Line-listing of all diagnosed and reported gonorrhea and syphilis cases, consistent with protocol and cumulative from the beginning of the calendar year

Every 2 months

2 - Case Laboratory Records

Line listing of all STI-related laboratory tests (from all sources, including ELR) associated with reported case, consistent with protocol and cumulative from the beginning of the calendar year

Every 2 months

3 - Case Treatment Records

Line listing of all STI-related treatments/medications for reported cases, consistent with protocol and cumulative from the beginning of the calendar year

Every 2 months

4 - Provider Reference file

Each unique reporting facility/provider documented in separate record that reported one or more cases in the previous calendar year

Initial submission, updated annually thereafter

Year-End Datasets (1-4)

Final, cleaned and validated annual cumulative datasets containing all records consistent with protocol for the previous calendar year. These serve as the primary analytic data

Due March 15th of each year of the cooperative agreement

Strategy C – Surveillance Focus Activities: Short-term activities to evaluate methods, monitor STI/HIV testing, diagnosis, treatment, sequelae, and eligibility/uptake of HIV-prevention interventions.

Strategy C activities are shorter-term (1-year) single or multi-site projects intended to improve quality and use of surveillance data, explore new methods for monitoring the burden of reportable and/or non-reportable STIs, investigate sequelae of STIs, monitor uptake of biomedical interventions and monitor adverse health outcomes across the full range of community and provider settings. Funding for Strategy C activities is discretionary and dependent on availability of Federal funds; not all proposed Strategy C activities will necessarily be funded, and no Strategy C activities at all may be funded in some budget periods. Not all applicants for a given activity will necessarily receive funding in any given budget period either, based on availability of Federal funds. Strategy C activities may change, be revised, or be retired in subsequent budget periods, reflecting CDC priorities. Priority funding for Strategy C activities will be based on technical review of proposed projects separate from review criteria for Strategy A and Strategy B proposals. If Federal funds are not available for Strategy C activities, no technical reviews will be conducted, but proposals will be archived.

All applicants are required to propose at least one (1) but no more than two (2) Strategy C activities from the list of those relating to their proposed core surveillance strategies (see activities C.1- C.7) or those recommended for any applicant (see activities C.8 & C.9).

Applicants must include a one-page, separable, narrative for their proposed Strategy C activity identifying the activity by number as listed below and include a project plan for their local implementation. A separate 1-page budget justification for each proposed Strategy C activity should also be included and applicants should also address any proposed Strategy C activity in their work plan. Recipients should prepare reasonable budget requests of no more than $100,000 for any individual Strategy C activity.

Strategy C Activities for Strategy A Recipients:

C.1: Improvements to medical record systems – enhancements to clinic-based electronic medical record (EMR) or electronic health record (EHR) systems supporting collection of SSuN data for Strategy A during patient visits. Recipients are invited to propose innovative approaches to automate, increase efficiency, and lower burden data collection from clinic patients and to initiate design/requirements collection or to implement ‘off-the-shelf’ solutions achievable with available resources to enhance and facilitate Strategy A visit-level data management, data cleaning, automated reporting, or enhanced analysis and visualization to support SSuN activities and to monitor patient care.

Expected outputs:

i. Documented system requirements and implementation plan.

ii. Documented system modifications, datasets, data entry screens, and/or reports.

C.2: (a) HIV-PrEP Patient Monitoring (b) doxy PEP Monitoring – develop clinic-based panel of PrEP (or doxy PEP) users and provide for quarterly monitoring of STI screening, STI behavioral risks, incident diagnoses of STIs and PrEP (or doxy PEP) use, and maintenance as documented through prescriptions or dispensing.

Expected outputs:

i. Quarterly reporting/monitoring of:

a. Proportion of eligible patients referred to, initiating, and maintaining HIV PrEP

(or dPEP).

b. Proportion of HIV PrEP/doxy PEP users screened for STIs in compliance with guidelines.

c. Proportion of HIV PrEP/doxy PEP users diagnosed with STI(s).

d. Proportion of HIV PrEP/doxy PEP users maintaining HIV PrEP/doxy PEP at quarterly intervals.

e. Proportion of HIV PrEP/doxy PEP users lost to follow-up at quarterly intervals.

C.3: Technology to Enhance HIV PrEP Monitoring – implementation of clinic-based technologies for PrEP adherence support, recall/scheduling management and monitoring (SeraAlert, SMS, etc.)

Expected outputs:

i. Documented system requirements and implementation plan.

ii. Proportion of HIV PrEP patients enrolling and actively using platform.

iii. Evaluation of the platform’s user (patient) acceptability and effectiveness.

C.4: Evaluating HIV PrEP uptake and retention – comprehensive analysis of co-factors of HIV PrEP initiation and maintenance, with focus on transgender persons and women of color. May include records-based analyses supplemented with qualitative methods such as surveys, focus groups and/or interviews. Compliance with local IRB requirements will be required.

Expected outputs:

i. Comprehensive analysis of co-factors facilitating HIV PrEP uptake and maintenance.

ii. Comprehensive analysis of co-factors inhibiting HIV PrEP uptake and maintenance.

iii. Programmatic recommendations for enhancing HIV PrEP uptake and maintenance among sex and gender minorities and women of color.

Strategy C Activities for Strategy B Recipients:

C.5: Enhancements to local surveillance data systems supporting collection of SSuN data for Strategy B: Recipients are invited to…