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NATIONAL ASSOCIATION OF COUNTY & CITY HEALTH OFFICIALS GRANT AWARD Scope of Work– Maricopa County Department of Public Health April 1, 2021 through Project: Pharyngeal Test of Cure Project July 31, 2022 Project Background Neisseria gonorrhoeae is the second most common notifiable disease in the United States with over 500,000 cases reported in 2018 and gonococcal infections in males and females continue to increase in the United States. Untreated gonococcal infection can lead to serious sequelae including pelvic inflammatory disease, ectopic pregnancy, infertility, epididymitis, and disseminated gonococcal infection and can facilitate HIV acquisition and transmission. Timely and effective treatment of gonococcal infections can prevent these adverse health outcomes and subsequent transmission in the community. However, the treatment and control of N. gonorrhoeae have been complicated by the organism’s ability to acquire antimicrobial resistance. Starting in 2010, CDC recommended combined therapy with ceftriaxone 250mg intramuscularly and azithromycin 1g orally as first-line treatment for uncomplicated gonorrhea. Due to the development of antimicrobial resistance to multiple classes of antibiotics, including current first line therapies, gonorrhea was designated as one of five urgent antibiotic resistance threat level pathogens in the United States in 2019. Increasing concern for antimicrobial stewardship and the continued low incidence of ceftriaxone resistance in the United States has led to reevaluating the need for dual therapy. CDC has updated the 2015 gonococcal treatment recommendations and recommends a single dose of ceftriaxone 500mg intramuscularly as treatment for uncomplicated gonorrhea. Treatment failures with ceftriaxone, occurring primarily at the pharynx, have occurred outside of the U.S. with strains demonstrating ceftriaxone minimum inhibitory concentrations (MIC) of >0.25 µg/mL. Although the development of resistance in N. gonorrhoeae is not fully understood, the pharynx may serve as an incubator of resistance due to the lower drug concentrations at this anatomic site and increased opportunity to exchange genetic material with other bacteria. Therefore, the implementation of a test of cure (TOC), defined as performing N. gonorrhoeae culture or nucleic acid amplification testing (NAAT) 7–14 days after initial treatment for all cases of pharyngeal N. gonorrhoeae could potentially identify and prevent the spread of antimicrobial-resistant gonorrhea. CDC recommends a TOC for persons with pharyngeal gonorrhea by using either culture or NAAT 7–14 days after initial treatment, regardless of regimen, to ensure eradication or detection of a possible treatment failure. The feasibility of implementing TOC for all pharyngeal N. gonorrhoeae cases in clinical practice has not been previously evaluated. Health department sites funded to participate in this project will implement and evaluation an approach to pharyngeal TOC. All sites will share their evaluation and project results to (1) assess the feasibility of implementing TOC for all pharyngeal gonorrhea infections in routine clinical practice, (2) understand the yield needed to detect treatment failures to CDC-recommended first-line gonorrhea treatment, (3) identify models and best practices for monitoring and responding to potential treatment failures, and (4) explore relationships of gonococcal strains that fail CDC-recommended first-line treatment and detect genetic markers associated with antimicrobial resistance. As a participating site, Maricopa County Department of Public Health will create or refine an implementation plan and evaluation plan, collect site-level data, work with NACCHO and CDC on analysis, discuss implications of the results for best practices and lessons learned, and share and discuss their lessons learned with other jurisdictions. NACCHO, CDC, and participating jurisdictions will contribute to the following anticipated outcomes of the project: • Analyzed site-level qualitative and quantitative data related to individual jurisdiction interventions, which will provide critical information about each approach and inform best practices and lessons learned • Collected resources, such as protocols and standard operating procedures, patient flow diagrams, staffing models, and provider and patient education materials, to be shared with other jurisdictions interested in establishing or scaling-up similar interventions; and • Report(s) on best practices and lessons learned Scope of Work In support of the Pharyngeal Gonorrhea Test of Cure (TOC) project, Maricopa County Department of Public Health will complete the following activities: • Finalize a plan to implement TOC performance for all pharyngeal gonorrhea cases at participating STD clinics. • Finalize a plan to evaluate the implementation of the project. • Implement the pharyngeal gonorrhea TOC project • Collaborate with NACCHO and CDC/DSTDP to collect, analyze, interpret, and synthesize evaluation findings. • Collaborate with NACCHO and CDC/DSTDP during and post-project period to share ongoing lessons learned and findings, through reports, webinars, and limited 1:1 technical assistance with other areas interested in learning more about implementation of TOC for all pharyngeal gonorrhea cases. • Participate in any scheduled project conference calls, as appropriate. • Provide relevant staff and sufficient staff time to manage the project in collaboration with NACCHO and CDC/DSTDP. Reimbursement Maricopa County Department of Public Health will submit invoices according to the following schedule with the following deliverables: Invoice No. Amount Deliverables Due Date Invoice I $17,500 • Draft pharyngeal By May 15, 2021 gonorrhea test of cure (TOC) implementation plan Invoice II $17,5000 • Final TOC By June 1, 2021 implementation plan Invoice III $17,500 • Draft evaluation By June 15, 2021 plan Invoice IV $17,500 • Final evaluation plan By July 15, 2021 Pending CDC Approval of Grant Extension: Invoice V $5,000 • Participation in staff By November 30, interviews 2021 Invoice VI $10,000 • Progress report that By December 31, details the status of 2021 implementing and evaluating TOC Invoice VII $14,977 • Site-specific By June 30, 2022 summary and full project report that details the outputs (e.g. protocols, educational materials) and outcomes (e.g., lessons learned, assessment findings) of implementing and evaluating the CS intervention Reporting Project sites will participate in virtual meetings and phone calls as-needed as determined by NACCHO. Budget and Justification 4/1/2021 PHARYNGEAL GONORRHEA TEST OF CURE PROJECT Maricopa County Department of Public Health, Clinical Services Division Proposed Budget Amount: $ 99,977 Justification of Line Description of Line Item Amount Item Salaries Epidemiologist Senior $17.00(2088) $ 35,496 Medical Assistant $8.00(2088) $ 17,748 Salaries Subtotal: $ 53,244 Fringe Benefits Epidemiologist Senior Variable Benefits 19.87% of Salary $ 7,053 Epidemiologist Senior Fixed Benefits $13,632 per FTE $ 6,816 Medical Assistant Variable Benefits 19.87% of Salary $ 3,527 Medical Assistant Fixed Benefits $13,632 per FTE $ 6,816 Fringe Benefits Subtotal: $ 24,212 Supplies Office Supplies $ 2,200 Supplies Subtotal: $ 2,200 Other Patient Transportation (Return for TOC) 450 @ $10 each $ 4,500 Other Subtotal: $ 4,500 Indirect Indirect Expenses 18.80% $ 15,821 Indirect Subtotal: $ 15,821 Total Proposed Budget TOTAL $ 99,977 Attachment A Budget Justification Salaries $53,244 This line item is for salaries for two 0.5 positions. It will not take two full time FTE’s to perform the functions of this project. Therefore, it is proposed that .5 of the salaries of two existing employees, a Sr. Epidemiologist and a Medical Assistant, be paid by this project with the other .5 of the salaries being paid from the STD Program (using existing county general funds). The Sr. Epidemiologist will be responsible for the data related to this project, including the collection, assessment, analysis and reporting functions. The Medical Assistant will be responsible for follow-up with positive patients and getting patients to return to the clinic for test of cure. Benefits $24,212 The variable benefit rate for Maricopa County employees is 19.87% of salaries. Because this project will be paying half the salary for the Sr. Epidemiologist and the Medical Assistant, the variable benefits will also be split in half using existing county general funds. The same will be true for the fixed benefit costs, which is $13,632 per FTE ($6,816 per 0.5 FTE). Supplies $2,200 Supplies purchased for this project will be minimal and consist solely of general office supplies (paper, ink, copies, etc.). Other $4,500 Expenditures in this category will be targeted for patient transportation costs (taxi or other ride sharing options) for patients that will return for test of cure but do not have transportation available. Indirect $15,821 The current negotiated indirect rate for Maricopa County is 18.80% of direct expenses.