This study was part of a HRSA Special Project of National Significance (SPNS 047) initiative entitled “Curing Hepatitis C Among People of Color Living with HIV”which was awarded to Yale School of Medicine and conducted in partnership with the CT DPH. The project was funded from 9/30/2017-9/30/2021. This study was conducted between 9/1/2019 and 3/31/2020.
Study Aim:
Evaluate the effectiveness of a Data to Care Approach for identifying and re-engaging OOC PWH with HCV Co-infection into HCV treatment
Study Setting:
CT currently ranks 16th in HIV cases with HIV prevalence at the time of this study (2019) was 10,705 (299/100,000). Demographically, 68% of cases were in persons of color (Black, Hispanic); 63% aged 50 or older; MSM 31%; heterosexual 28%; IDU 26%. Incident HIV cases have declined with 220 new HIV diagnoses in 2019. It was estimated that 80% of PWH were engaged in care in 2019 with 74% virally suppressed. Data regarding HIV/HCV co-infection is less robust but between 2016-2019, it was estimated there were 541 persons with co-infection, primarily in PWID (78%). HCV treatment is distributed among providers in HIV clinics, primary care and hepatology clinics.26
Surveillance Data Sources
Two CT DPH surveillance databases were used: the enhanced HIV/AIDS Reporting System (eHARS) for HIV and the CT Electronic Disease Surveillance System (CTEDSS) for HCV. The CDC developed eHARS for public health agencies to collect and report HIV surveillance data.25,27 The CT DPH uses CTEDSS as their notifiable disease repository for CDC-required reporting. In CT, HIV data in eHARS dates to 1981 and CTEDSS recorded data beginning in 1994. CTEDSS includes HCV antibody (positive only) and polymerase chain reaction (PCR) (positive and negative) results. Negative PCR results have been reported through electronic lab reporting (ELR) since 2016. Roughly 80% of all HCV laboratory results in CT are reported through ELR.
Inclusion Criteria for Data to Care Intervention
The D2C intervention focused on persons with HIV/HCV co-infection who were OOC for HIV and had untreated HCV. Figure 1 outlines the flow of surveillance data for determining eligibility for the intervention. First, the CT DPH epidemiologist created an HIV/HCV co-infected list by matching eHARS (from 1/1/2009 to 8/6/2019) and CTEDSS (from 1/1/1994 to 8/17/2019) using a CDC developed hierarchical deterministic matching program in SAS 9.4.9 Matching keys consisting of identifiable variables to determine persons present in both surveillance systems including: first name, last name, date of birth, and social security number.28 We chose the greater duration of time for CTEDSS to capture the largest possible pool of HCV data available. We chose the 10-year timeframe for eHARS to optimize the list of PWH who were more likely to be living and residing in CT.
Figure 1: Surveillance data flow for identification of Persons with HIV (PWH) who qualify for the Data to Care intervention
Using the same eHARS list, the CT DPH epidemiologist created a list of PWH who were diagnosed with HIV prior to or including 2018 which included their most recent HIV laboratory results (eHARS data from 1/1/2009 to 8/6/2019). Persons who received an HIV diagnosis in 2019 were excluded since a full year is needed to finalize and confirm HIV data. The CT DPH epidemiologist created the 12-month PWH OOC list to include persons who had no HIV laboratory results from 8/1/2018 to 8/6/2019. The Yale epidemiologist generated the 12-month HIV/HCV co-infected OOC cohort list by matching the PWH OOC list to the HIV/HCV co-infected list. Before finalizing the list, HCV data were evaluated using CTEDSS to exclude anyone with evidence of HCV viral clearance (as defined by positive HCV PCR followed by negative PCR). For this research purpose, data from eHARS were accessed on 8/6/2019 and from CTEDSS, on 8/17/2019.
Process for Identifying, Locating, and Re-engaging HIV OOC Persons with HIV/HCV Co-infection
List generation: After generating the list of eligible PWH as noted above, a tracking log (an Excel spreadsheet consisting of patient identifying information, HCV and HIV laboratory details) was created for recording outcome data, that was manually filled in by the DIS supervisor and DIS staff. Using this list, three phases of further data cleaning and assignment to DIS workers began (see Figure 2).
Figure 2: Consort diagram showing eligibility for the phases of the Data to Care intervention for the 12-month OOC Cohort (N=90)
Phase 1-Pre-Work: The goal of Phase 1 was to use available DPH data systems to streamline the co-infected lists to include persons who were alive, residing in CT, not treated for HCV. The DIS supervisor used the Department of Corrections (DOC) database, LexisNexis, and CTEDSS (data updated regularly throughout the project) as ancillary databases to assess eligibility for Phase 2 case conferencing. Persons who were deceased, incarcerated, out of state (OOS) residents, and those with at least one negative PCR result reported through CTEDSS (indicating prior successful treatment or spontaneous clearance) were not eligible for Phase 2. Persons lacking a provider or sufficient contact information were eligible for Phase 2.
Phase 2-Case Conferencing: The goal of Phase 2 was to solicit clinic-level information through a direct conversation between the DPH and clinic staff (case conferencing). The DIS supervisor spoke with relevant clinic staff who reviewed medical records to verify if their patients were truly OOC for HIV and to ascertain their HCV treatment status since data in CTEDSS were not always up-to-date due to data backlogs. If needed, the DIS supervisor contacted eligible patients’ last known HIV provider obtained from eHARS by phone. The ensuing discussions yielded updated outcomes that were recorded in the tracking log. Persons eligible for active DIS follow-up (Phase 3) included patients lost to follow-up by the clinic and those with insufficient information to determine eligibility.
Phase 3-DIS Follow-Up: The goal of Phase 3 was active case-finding by DIS workers. The CT DPH employed three dedicated DIS to locate and contact patients needing care engagement including those OOC for HIV. DIS tracked assigned patients, assessed barriers to care after contact, provided HIV and HCV brief treatment education, and facilitated re-engagement with the HIV clinic. Patients were actively followed-up for 30 days once DIS efforts began. If a patient was contacted, the DIS would work with the patient until they were re-engaged (defined as making a provider appointment). If after 30 days there was no response to DIS, passive efforts (awaiting responses to initial contact efforts) would continue for another 60 days.
Outreach methods followed a dedicated protocol (see Appendix) and included phone calls, text messages, emails, field visits, and letters with most recent contact information supplemented by clinic records; use of these methods was not mutually exclusive, e.g. if needed, phone calls and field visits were used with the same patient. Tabulation of outreach efforts was designated by final outcome, e.g. persons who were successfully re-engaged had relevant outreach efforts attributed to that outcome. Progress and outcomes for Phase 3 were recorded in REDCap, a secure web-based electronic data capture tool hosted at Yale University.
Outcome Definitions:
(1) Successful contact - DIS reached a patient to schedule a clinic appointment.
(2) Successful re-engagement - patient had either a scheduled appointment or clinic visit with an HCV treatment provider by the end of study. The re-engagement success rate is calculated as the ratio of those re-engaged to those successfully contacted.
(3) Cure - clinic or surveillance based evidence of SVR (defined as HCV PCR negative 12 weeks post treatment).
Project Variables
Surveillance variables included first name, last name, date of birth, birth sex, race/ethnicity, HIV transmission category and most recent available HIV viral load (VL) results and date.
Statistical Analysis
Descriptive analyses were performed to examine the distribution of demographic and HIV clinical information variables for each OOC cohort observed during each project phase. The variables included birth year, age, birth sex, race/ethnicity, HIV VL level, and HIV transmission category. Descriptive analyses were also performed to examine the outreach methods used and time spent by DIS for patient follow-up.
Ethical Considerations
This project was approved by the Yale IRB (protocol #2000025960) and the CT DPH Human Investigations Committee (protocol #914). The CT DPH Human Investigations Committee gave permission for a Yale researcher (MW) to only view identifiable information while physically at the DPH and no data was accessible outside the DPH. All study data were located and secured at the CT DPH according to their internal policies.