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Aug 1 -- The Centers for Disease Control and Prevention (CDC) invites comments to OMB by August 31, 2023 regarding proposed revisions to  the STD Surveillance Network (SSuN).

The National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHSTP) is requesting a Revision of the Information Collection Request (ICR) titled, The STD Surveillance Network (SSuN). Revisions to this submission include addition of mpox-related data elements for monitoring mpox risk, vaccination, diagnoses, and laboratory testing as part of ongoing surveillance for this emergent public health issue. Additionally, this Revision ICR incorporates future expansion of SSuN to additional STD clinical facilities, addition of several new data elements to sentinel surveillance activities in STD clinical facilities related to Pre-Exposure Prophylaxis for HIV (PrEP), and enhanced investigations of a random sample syphilis cases reported to participating health departments. Multiple data elements associated with enhanced gonorrhea case investigations and provider reporting forms are also being retired. The estimate of annualized burden hours for this revised data collection increases from 5,863 hours to 7,487 hours.

The purpose of this project is to enhance national capacity for STD surveillance and to better meet CDC's disease surveillance mandate by: (1) addressing gaps in epidemiologically-relevant information by providing more complete behavioral and demographic data on reported cases of notifiable STDs to enhance the ability of public health authorities to interpret trends in case incidence, assess inequalities in the burden of disease by population characteristics and to monitor STD treatment and selected adverse health outcomes of STDs; (2) monitoring STD and HIV co-infection, screening, uptake of STD and HIV prevention interventions and health care access trends among patients seeking care for, and those diagnosed with, STDs in specialty clinical settings; and (3) providing a robust sentinel monitoring system for newly emergent and/or re-emergent health threats such as mpox.

Routine STD case surveillance activities are ongoing in all US jurisdictions. Cases diagnosed in U.S. jurisdictions are voluntarily reported to CDC through the National Notifiable Diseases Surveillance System (NNDSS) and case data are collaboratively defined in cooperation with the Council of State and Territorial Epidemiologists (CSTE). However, case data received by CDC through NNDSS are increasingly missing required patient demographics and are extremely limited in scope with respect to risk behaviors, treatments prescribed, co-infection with other infections, preventive services, and sexual network characteristics. These data are needed to monitor incidence and prevalence and to inform prevention and control efforts.

Additionally, clinical information on patients seeking STD-specific care in specialty STD clinics is not available through any other national medical record abstracts or data sources. These data are critical to detecting emergent STD-related sequela or reemergence of mpox, appropriately informing local disease control activities and to inform analyses of national trends in the epidemiology of STD incidence. These data are also useful to monitor care services in essential safety-net STD clinics and evaluate local and national STD prevention and control measures. SSuN is the only surveillance infrastructure providing such comprehensive, representative information on patient and sex-partner characteristics, clinical presentation, STD screenings, uptake of HIV testing, screening for and uptake of mpox vaccine in STD clinics, curative and preventive treatment patterns, provider compliance with treatment recommendations, HIV co-infection among persons diagnosed with STDs and uptake of STD and HIV prevention interventions such as pre-exposure prophylaxis for HIV (PrEP) and/or Post-Exposure Prophylaxis (PEP) for bacterial STDs. These measures are key elements of the U.S. national strategy to End the HIV Epidemic (EHE) and support the Sexually Transmitted Infections, National Strategic Plan for the United States.

The STD Surveillance Network was established in 2005 as a network of six initially funded state and local public health agencies providing more comprehensive STD case-level and clinical facility information. In 2008, SSuN was expanded to 12 recipients to add important geographic diversity and to include visit-level data on a full census of patients being seen in categorical STD clinics. The network's activities were continued in a third funding cycle in 2013, with 10 recipients conducting core data collection activities in STD clinics and among a random sample of reported cases.

The current project, SSuN Cycle 4 (2019–2024), comprises 11 U.S. local/state health departments, including Baltimore City Health Department, California Department of Public Health, City of Columbus Public Health Department, Florida Department of Health, Indiana Department of Public Health, Multnomah County Health Department, New York City Department of Health & Mental Hygiene, Philadelphia Department of Public Health, San Francisco Department of Public Health, Utah Department of Public Health and Washington State Department of Health.

SSuN Cycle 4 continues to provide critical information addressing CDC's Division of Sexually Transmitted Disease (DSTDP) priorities as articulated in the STI National Strategic Plan, including contributing data to CDC's annual STD Surveillance Report, CDC's quarterly progress indicators and contributing to the body of literature related to STDs. Trend data across multiple cycles of SSuN are frequently used to inform policy discussions on prevention and treatment recommendations for common bacterial STDs. Of particular importance, SSuN provides data on use of pre- and post-exposure prophylaxis to prevent STDs and HIV infection (PEP and PrEP). SSuN also provides documentation of critical changes in clinical services provided by specialty STD clinics, and on the proportion of cases treated with appropriate antimicrobial regimens, an essential indicator of compliance with CDC treatment recommendations to combat the emergence of antimicrobial resistance (AMR). More recently, SSuN data have also been invaluable in assessing COVID–19 and mpox impacts on reported case incidence and patient access and care-seeking patterns and provides a reliable monitoring infrastructure for mpox re-emergence. STD clinics were the front-line provider of choice for persons suspecting mpox infection or seeking preventive services such as mpox vaccination.

Data collection components of SSuN are grouped into two primary strategies, reflecting different sentinel and enhanced population-based surveillance methods and activities. Strategy A includes sentinel surveillance in STD clinics to monitor patient care, screening and diagnostic practices, HIV co-infection, treatment and STD-related HIV prevention services delivered to patients. In collaboration with participating local/state health departments and their clinical partners, SSuN implements consensus protocols to collect demographic, clinical and risk behavior data on patients presenting for care in selected specialty STD clinics. Records for patients presenting for care are also matched to the jurisdiction's HIV surveillance registry, providing data on HIV co-infection not currently available from any other multi-jurisdictional source. Data for these activities are abstracted from existing electronic medical records at participating STD clinics, leveraging information that is already collected in the provision of routine STD clinical care. All records are fully de-identified by collaborating facilities or health departments and transmitted to CDC through secure file transport mechanisms six times annually.

The second core data collection activity, Strategy B, currently includes: (1) abstraction recoding and reporting of all gonorrhea and syphilis cases reported in the collaborating jurisdiction; (2) enhanced investigations on a random sample of all persons diagnosed with gonorrhea or syphilis; and (3) health department abstraction and registry matching for a complete census of reported gonorrhea and syphilis cases. For the first activity, a random sample of all gonorrhea cases diagnosed and reported to health departments within the participating jurisdictions are selected for enhanced investigations. Beginning in 2024, these investigations will be expanded to include a random sample of reported syphilis cases, include abstracting clinical data from diagnosing providers, matching cases with existing health department disease registries and brief patient demographic and behavioral interviews (10 minutes per response). The population of interest includes all persons diagnosed and reported with gonorrhea and syphilis; existing case records are matched to other health department disease registries to determine co-infections and to document laboratory and treatment information known by the health department through routine case investigations and local laboratory reporting. In the proposed Revision, syphilis cases will also be selected for enhanced provider and patient investigations utilizing the same consensus protocols used for enhanced gonorrhea case investigations. Considering recent increases in syphilis cases in the U.S., especially congenital syphilis, these data are critical to informing local and national syphilis prevention and control activities. SSuN recipients implement protocols providing uniformly coded data on demographic characteristics, behavioral risk factors, clinical care, laboratory data and health care seeking behaviors that are combined into a national dataset following data quality assurance at CDC.

In 2021, there were 211,791 cases of gonorrhea diagnosed and reported across the 11 current recipients of SSuN. Approximately 7.4%, or 15,715 cases were randomly sampled for enhanced investigation; full enhanced investigations were completed for 6,186 (39.4%). During the COVID–19 public health emergency, a slightly larger proportion of cases were lost to follow-up than in prior years due to local staffing shortages, issues with timely laboratory and case reporting, and higher than average patient refusals.
SSuN https://www.cdc.gov/std/ssun/default.htm
CDC submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202306-0920-010 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN: https://www.federalregister.gov/d/2023-16220

For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at https://www.aeaweb.org/content/file?id=5806

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