Check Hep C is a patient navigation program designed to provide linkage to care for New York City (NYC) residents with hepatitis C. To be eligible for the program, patients must reside in NYC, have a positive HCV RNA test, and enroll at one of 14 program sites in NYC. Program sites were located in 4 of 5 NYC boroughs and included federally qualified health centers, nonprofit health systems, and public hospitals.

Once enrolled, patients are supported by patient navigators to complete hepatitis C medical evaluation and treatment. Patient demographic, medical, and treatment information are collected and stored in the NYC Department of Health and Mental Hygiene (DOHMH) Viral Hepatitis Program’s Research Electronic Data Capture (REDCap) cloud database.^7,8 REDCap data are extracted monthly and manually reviewed and deduplicated by Viral Hepatitis Program staff. Patients who were diagnosed with hepatitis C and enrolled in the Check Hep C program from July 1, 2016, through June 30, 2020, were included in this analysis.

The NYC DOHMH hepatitis C surveillance system contains patient demographic and laboratory data records for NYC residents reported to DOHMH through provider and electronic laboratory reporting. Electronic laboratory reporting for hepatitis C is mandated for all positive antibody, positive RNA, and genotype results. Electronic laboratory reporting of negative RNA results was implemented in 2014. Negative HCV RNA results are imported into the surveillance system when they match to a patient who has had a previous positive hepatitis C test result. All hepatitis C tests for the same person are automatically deduplicated. Partial matches that are unable to be automatically deduplicated are manually reviewed by surveillance staff.

Check Hep C patients were matched to the NYC Health Department HCV surveillance registry based on a match key using the first 6 characters from the patient’s name and the date of birth. Partial matches were manually reviewed, and matches to more than 1 record in the surveillance registry were resolved.

Check Hep C program data and RNA tests reported to the DOHMH were used to define treatment and clearance status. Clinical cure was determined for patients who completed treatment using Check Hep C program data only. Patients were considered to have completed treatment if they had a treatment start date and either (1) had a treatment completion date or (2) the patient navigator otherwise indicated that treatment had been completed. Patients who had a treatment completion date but were either missing status of sustained virologic response (SVR) 12 weeks posttreatment (SVR12) or discontinued treatment were considered to have not achieved SVR12. Clinical cure was abstracted from the Check Hep C data and defined as the navigator indicating that the participant achieved SVR12. Laboratory-based clearance was determined using RNA tests from the DOHMH hepatitis C surveillance system. Laboratory-based clearance was defined as any negative RNA test result after a positive RNA test after program enrollment.⁶ RNA test results that reported RNA was detected but not quantifiable were considered positive.

Check Hep C program data were used to describe the characteristics of people with HCV infection who were enrolled in the program during the analytic period (July 1, 2016, through June 30, 2020). Characteristics of patients who completed treatment were compared with patients who either did not start or did not complete treatment using a chi-square test. Only patients who completed treatment were included in comparisons of clearance definitions.

For patients who completed treatment, a 2-by-2 table was constructed to summarize how the clinical cure definition compared with the laboratory-based clearance definition. Percent positive agreement (PPA), percent negative agreement (PNA), overall agreement, and Cohen’s kappa statistic were calculated to determine the validity of the laboratory-based clearance definition. The kappa statistic is a measure of agreement that ranges from 0 (lowest agreement) to 1 (highest agreement) and takes into consideration that some agreement might occur by chance. Lastly, patients whose clinical cure and laboratory-based clearance determinations were not in agreement were investigated. Reasons for discordance were explored qualitatively using information collected by Check Hep C patient navigators and from RNA testing trends observed in the surveillance data. All statistical analyses were performed using SAS Enterprise Guide 7.1. This project was reviewed by CDC, was exempted from institutional review board oversight because it did not involve human subjects research, and was conducted consistent with applicable federal law and CDC policy (eg, 45 CFR 46.102[l]).

We obtained the demographic and clinical information of 1567 participants who enrolled in the Check Hep C Patient Navigation program from July 2016 through June 2020 (Table 1). Of the 1567 participants included in this analysis, 68.5% were male, 30.8% were female, and less than 1% were transgender. The median age at enrollment was 56 years (interquartile range: 47–63 years); 38.0% of participants were older than 60 years and 15.2% were less than 40 years old at the time of enrollment. Nearly three-quarters of the participants were either Black (39.1%) or Latino (34.2%). Almost half of the participants reported ever using drugs (46.5%), and 18.2% reported injecting drugs within the past year. Thirty one percent of participants were ever incarcerated, 5.9% were homeless at any time while enrolled in the program, and 13.0% were living with HIV.

Among 1567 Check Hep C participants, 733 (46.8%) were not started on treatment (Table 1 and Figure). Program notes mention various reasons for not starting treatment including referral to another program, insurance issues, competing health issues, refusal of care, and loss to follow-up. From the NYC surveillance data, 291 of 733 had a subsequent negative RNA after enrollment in Check Hep C, which could be due to either treatment in another program or spontaneous clearance. Participants who either did not start treatment (n = 733) or did not complete treatment (n = 104) were more likely to report injection or intranasal drug use in the past year, experience homelessness while enrolled, and were enrolled more often in later program years compared with participants completed who treatment (Table 1).

Of the 834 participants who started treatment, 714 (85.6%) met the inclusion criteria and completed treatment. Of those who completed treatment, 575 (80.5%) participants met the definition for clinical cure, 16 (2.2%) did not achieve clinical cure, and 123 (17.2%) had unknown clinical cure status because data on SVR12 status were missing (Table 2). Upon matching the 575 patients who were clinically cured to surveillance data, 568 met the laboratory-based clearance definition. The laboratory-based clearance definition had a PPA of 98.8% (95% confidence interval [CI], 97.5%–99.4%) and a PNA of 31.3% (95% CI, 14.2%–55.6%) when compared with clinical cure (Table 3). The overall agreement was 97% (95% CI, 95.2%–98.1%) with a calculated kappa statistic of 0.34. There were 18 cases where the laboratory-based clearance and clinical cure determinations were discordant.

Of the 123 participants who completed treatment but for whom clinical cure status could not be ascertained (missing SVR12 status), 112 (91%) were discharged from the program and assumed to be missing treatment outcome due to loss to follow up. Fifty two percent were lost to follow-up prior to their SVR12 appointment. However, among this group, 93.5% (115 of 123) had a follow-up negative RNA test result dated after enrollment in the HCV surveillance system.

There were 7 patients who were considered clinically cured but did not meet the laboratory-based clearance definition (ie, did not have negative RNA test results in the HCV surveillance system). Three participants did not have any RNA test results in the HCV surveillance system after their enrollment date (Table 4, scenario 1). One of these 3 participants relocated shortly after participating in the Check Hep C program. RNA testing for SVR12 outside of NYC, if performed, would not have been reported to the NYC DOHMH. Another participant had a single, positive RNA result in the surveillance data 18 months after achieving clinical cure (Table 4, scenario 3). RNA testing patterns showed that the remaining 3 participants tested RNA positive between program enrollment and their treatment completion date; however, these participants did not have any follow-up RNA test results available after treatment completion in the surveillance data (Table 4, scenario 2).

There were 11 participants who did not meet the clinical cure definition but were classified as cleared by the laboratory-based definition (Table 5). Six participants tested RNA negative after treatment completion but had a subsequent positive RNA test result within 6 months of completing treatment (indicative of treatment failure) (Table 5, scenario 1). Three participants tested positive after treatment completion and had subsequent negative RNA tests (Table 5, scenario 2). One participant did not meet the clinical cure definition but had a negative RNA 1 month after completing treatment; clinic notes indicate that the clinic navigator was trying to get this person back into care (Table 5, scenario 3). Lastly, 1 participant discontinued treatment due to adverse effects; their single negative RNA test result 2 months before completing treatment is indicative of early virologic response rather than cure (Table 5, scenario 4).