The Philadelphia Department of Public Health (PDPH) serves the population of the City of Philadelphia, which comprises Philadelphia County. Philadelphia is the fifth-largest city in the United States, with a population of 1.5 million persons. Philadelphia is 43% black, 41% white, 11% Hispanic/Latino, and 5% Asian, and 11.5% of citizens are foreign-born. Philadelphia is also among the poorest of the nation's large cities: median household income is ~$36,251, and 25% of persons live below the federal poverty level. It is difficult to estimate how many PWID are current residents of Philadelphia; however, 2010 SAMHSA findings show that ~7,000 clients receive medication-assisted opioid therapy daily and Prevention Point Philadelphia (PPP), the city’s only syringe exchange program, currently serves approximately 52,000 people.
Philadelphia is at the center of a nationwide elicit-drug epidemic, predominantly resulting from a rise in heroin and prescription opioid use. The rise in drug use has been paralleled by an increase in hepatitis C virus (HCV) infection among young people. HCV surveillance data captured from Jan 1st, 2013 - June 30th, 2014 has demonstrated that while many people are lost at each stage of the HCV continuum, this is most dramatic for PWID. Three times as many HCV antibody-positive individuals who admitted to using drugs in the last 6 months had not received RNA confirmation, let alone linkage to care or treatment, than those who were not current drug users.
Our program was a collaboration between PDPH and PPP. Its primary goal was to aid the movement of PWID through the HCV care continuum by offering on-site confirmatory RNA testing for any PPP clients who tested rapid HCV antibody positive. Secondary goals were to enhance general HCV awareness among the PWID population and to expand surveillance of young HCV cases (≤30 years) in order to better understand evolving drug user trends and HCV transmission patterns.
The Health Department’s Hepatitis Prevention Coordinator had a long standing relationship with PPP prior to implementation of this program, paving the way for a successful first meeting between HEP and PPP. HEP proposed setting up an HCV testing program after assessing PPP’s hepatitis antibody testing practices and realizing how few antibody-positive clients were receiving confirmatory RNA testing and linkage to care. Implementation involved training HEP’s surveillance investigators in phlebotomy and developing a protocol whereby investigators would be on-site at PPP weekly to draw blood from anyone testing HCV antibody positive. Blood samples were tested by the PDPH Public Health Laboratory, and HEP reported results back to PPP the following week. Results were given to clients either in person or over the phone. Anyone testing RNA positive was connected to a PPP case manager who could link them directly to care at one of PPP’s partner clinics. To further address hepatitis awareness and education needs of PPP clients, HEP developed educational posters and pocket cards based upon discussions with PPP. HEP has also taken steps towards better understanding HCV transmission patterns among drug users by implementing more comprehensive surveillance of young HCV-positive patients.
This program is ongoing but has met its objectives to date. Prior to program implementation, HCV antibody-positive PPP clients were referred elsewhere for the confirmatory RNA test, and PPP was unable to track whether the testing actually occurred. By offering both the antibody and RNA tests at PPP, more HCV antibody positive clients are being confirmed and appropriately linked to care. In addition, PPP clients are becoming educated about HCV and actions they can take to prevent transmission. Similarly, antibody positive/RNA negative clients are being educated about their exposure and risk of reinfection. The success of this program has inspired PPP to get its own staff phlebotomy trained in order to offer confirmatory testing more than once a week.
This program was successful primarily because of the strong partnership developed between HEP and PPP. Since the program’s inception, staff from both organizations have met on a monthly basis to assure that everything is running smoothly and to discuss any changes that might improve the program.
The main public health impact of this program is the successful HCV testing and linkage to care of an especially vulnerable population. While not all PPP clients with the disease have been successfully tested, the program continues to develop ways to reach more at-risk patients who may be infrequent visitors to PPP. These include offering hepatitis testing within PPP’s mobile clinics, and providing incentives to clients who complete confirmatory testing and agree to be chaperoned to a partner health clinic.
The new HEP website, www.phillyhepatitis.org, due to launch in January, 2015 will include a section on this collaboration.
HCV is one of the most predominant public health issues affecting Philadelphians. It is estimated that 47,207 (2.9%) are living with the virus and >25,000 are unaware of their infection. The silent progression from acute to chronic HCV infection is a challenge for clinical management. To shift the continuum of care from unrecognized infection to diagnosis, treatment, and cure, people living with HCV need access to medical care, help navigating healthcare systems, and social services support. This is especially critical for PWID, where HCV rates can range from 10-40%, and few individuals are being diagnosed or treated. Indeed, Philadelphia is at the center of a nationwide elicit-drug epidemic, predominantly resulting from a rise in heroin and prescription opioid use. Heroin is cheaper and stronger than it is in other cities, encouraging uptake by a younger demographic.
PDPH serves a population of 1.5 million persons. PPP is located within the Kensington neighborhood of Northeast Philadelphia and conducts secondary syringe exchange for approximately 52,000 people.
HEP has conducted confirmatory RNA testing for 83 PPP clients to date, but has provided hepatitis education and resources to several hundred more.
Our project was initiated just as political interest began to focus on the recent increases in both HCV and injection drug use. While PPP has had testing for HIV in place for 15 years, rapid testing for HCV antibody has only been available for three years. This is largely because the funding for viral hepatitis prevention and surveillance activities have remained only a fraction of that allocated for HIV. In spite of the overwhelming burden of HCV disease in Philadelphia, very few resources have been in place to address this problem before now.
PDPH was in a unique position to establish this program. In 2012, the city was selected as one of seven sites nationwide to receive CDC funding to conduct hepatitis surveillance. This allowed the Health Department to launch HEP, an enhanced viral hepatitis surveillance effort aimed at better understanding the burden of chronic hepatitis infections in Philadelphia through detailed case investigation. Funding from this grant provided the Health Department with the staff required to establish a confirmatory testing program at PPP and the means to ‘track’ patients over time to assure that they are receiving follow-up testing and remaining in care. This effort comes at no charge to PPP, which is already financially strapped.
This program provides an innovative method to address the HP 2020 objectives of reducing the number of new infections, and increasing the proportion of individuals aware that they are infected. It is unique to government-run hepatitis programs because it creates a direct bridge from hepatitis surveillance activities in the Health Department to the external community. Direct evidence obtained from hepatitis investigation and lab reporting were used to target the population where most new infections are occurring, a confirmatory testing campaign was launched, and additional surveillance data on patient linkage and retention in care is being used to inform the success of the program.
This program is evidence-based, effectively integrating clinical expertise about how best to mobilize PWID through the HCV care continuum with patient values and literature findings.(1) Research finds that the best mechanism for reducing HCV infection rates among PWID is to make HCV testing services available within settings in which PWID feel secure, and in which other education, counseling, support group, and health services are offered.
1. Hagan H, Pouget ER, Des Jarlais DC. A systematic review and meta-analysis of interventions to prevent hepatitis C virus infection in people who inject drugs. J Infect Dis. 2011;204:74-83.
The primary goal of this program was to aid the movement of PWID through the HCV care continuum so as to contribute to the HP 2020 objectives of reducing the number of new infections, and increasing the proportion of individuals aware that they are infected. HEP’s secondary goals were to enhance general HCV awareness among the PWID population and to expand surveillance of young HCV cases (≤30 years) in order to better understand evolving drug user trends and HCV transmission patterns.
HCV has been reportable in Philadelphia since 2003; and with recent CDC funding, the surveillance capacity of the PDPH has expanded tremendously through establishment of HEP. Since Jan 1st, 2013, three hepatitis surveillance investigators have been conducting investigations of both newly reported hepatitis patients and their health care providers. HEP surveillance data captured through June 30th, 2014 has demonstrated that while many people are lost at each stage of the HCV continuum, this is most dramatic for people who inject drugs (PWID). Three times as many HCV antibody-positive individuals who admitted to using drugs in the last 6 months had not received RNA confirmation, let alone linkage to care or treatment, than those who were not current drug users. Our project targets PWID through a direct collaboration with PPP. Prior to implementation of this practice, HEP met with PPP staff to assess their hepatitis testing practices and design a mutually effective way for HEP to obtain test result information. While PPP had been regularly conducting HCV rapid antibody testing since late 2011, it was evident that they did not have the staff and time available to run the confirmatory RNA test in house. HEP proposed offering this service and the logistics were carefully mapped out by HEP and PPP staff. Implementation involved getting HEP’s surveillance investigators phlebotomy trained and developing a protocol whereby two investigators would be on-site at PPP once a week to draw blood from anyone testing HCV antibody positive. Samples were then hand delivered to the public health laboratory (housed in the same building as PDPH’s Division of Disease Control) for testing, and results were reported back to PPP the following week. Individuals testing RNA positive were connected to a case manager who could link them directly to care at one of PPP’s partner clinics. HEP staff were also trained on how to use the lab’s information system, including creating new records and printing labels for each blood sample. In January, 2014, the practice was piloted by offering blood draws on a Tuesdays, typically a quiet day at PPP, in order to refine the protocol and address any issues that arose. After HEP and PPP staff were comfortable, the practice was changed to Fridays, when PPP’s on-site clinic is operating and its most vulnerable clients are typically present. After successful implementation of the practice, HEP met with PPP to discuss additional needs related to hepatitis awareness and education for its clients. As a result of these discussions, HEP’s communications specialist created specialized posters, and a trifold wallet card for PPP clients to store their test result information and have easy access to hepatitis education, syringe exchange resources and safe injection practices. HEP has also taken steps towards better understanding HCV transmission patterns among drug users by implementing more comprehensive surveillance of young HCV-positive patients.
This practice began on January 1st, 2014 and is ongoing.
The primary stakeholders involved in implementing this program were the PPP Executive Director and Director of Programs. Additional PPP staff, including clinic personnel and case workers, also helped to establish the program, spread the word to clients about the additional testing being offered, and link HCV RNA positive clients to care. Collaboration between HEP and PPP was fostered through regular in-person meetings (first biweekly and then monthly) to discuss logistics, address concerns, and implement any necessary changes. The relationship PDPH’s Hepatitis Prevention Coordinator had already established with PPP also helped to pave the way for the HEP-PPP collaboration. Given the ban on Federal funding for exchange programs, and the controversial nature of this topic, PPP is wary of government intervention. The PPP executive director was much more receptive to the program than he might have been if trust had not already been established between PDPH and PPP.
To date, approximately $3,000 of HEP investigator time and $6,500 in laboratory costs have been spent on this project. This amounts to approximately $7800 in total costs per 100 clients served.
Since the program began, 466 people received HCV rapid antibody testing and 135 (29%) tested positive. Of the antibody-positive individuals, 83 (61%) received confirmatory testing and 59 tested positive. Taking into account that some HCV positive PPP clients received confirmatory testing elsewhere, 87 individuals were successfully linked to care at a Philadelphia area clinic. Recent literature findings suggest that HCV reinfection rate is low, so the continuous work of this project in identifying HCV cases for treatment evaluation should impact the number of new infections within the PWID community of Kensington. As such, this work meets our primary goal of helping to mobilize PWID through the HCV care continuum by offering on-site confirmatory RNA testing for PPP clients. Importantly, it does so for a vulnerable population that has challenges with access to medical care. While many states, including Pennsylvania, are in the process of implementing laws requiring medical professionals to offer one-time HCV testing to anyone born between 1945 and 1965 (ie. ‘baby boomers’), there are no policies in place to address the burden of HCV among PWID. We also met our secondary objective of increasing the HCV literacy of PPP clients by developing educational and harm reduction resources. To date, over 200 of the wallet cards have been handed out to PPP clients. Our objective of better understanding drug user trends and HCV transmission patterns among PWID is ongoing. Since expanding our surveillance form to acquire more detailed information on HCV-positive individuals < 30 years of age, we have completed 111 investigations, 33 of whom are current PWID.
Program evaluation is an ongoing process, and changes have been implemented as needed.
The primary data source for the confirmatory RNA result is the hepatitis surveillance registry housed at the Health Department. This data was all collected and entered by the hepatitis investigators.
Secondary data on HCV rapid antibody test results is obtained from PPP and entered into the hepatitis surveillance registry.
Performance measures are both process and outcome based. The process-based performance measures include number of tests performed per week, proportion of clients tested who have not received prior testing, and number of clients who return to PPP to obtain their test results and get linked to medical care. Outcome-based performance measures include total number of clients who received testing, proportion who tested positive, and proportion linked to care.
Results are analyzed by the hepatitis surveillance staff using data housed in the hepatitis surveillance registry.
Modifications have been made to the testing protocol since its inception. The weekly Health Department testing day was initially on Tuesday. When this proved successful, the hepatitis surveillance coordinator and PPP executive director changed the testing day to Friday, since this is a clinic day and more at-risk clients are typically on-site. The only drawback to Fridays is that clients do not return to PPP on a set schedule. To address this, PPP has made a separate file for anyone who received HCV RNA testing so that their test results are readily accessible when/if they return. PPP has also taken steps to get their own staff phlebotomy trained so that confirmatory testing can be offered more than once a week.
We found that making HCV testing opt-out for all clients being seen during the Friday PPP clinics was the best way to promote high weekly testing numbers. We also learned that having all HEP staff trained on the lab information system assured that the process ran efficiently once samples were returned to PDPH for testing. While creating the HCV educational materials, HEP learned through discussions with PPP staff and clients that the best way to convey disease information to this population is to use pictures and keep any language at a 3rd grade reading level. To enhance HCV investigation of PWID, HEP made the decision to use <30 years of age as a proxy for acute disease primarily among active drug users. Current drug use as a risk factor is far more predominant in this age group than in older age cohorts.
The HEP-PPP relationship has been a win-win for all parties involved. It has allowed hepatitis surveillance staff to take an active role in mobilizing HCV patients through the care continuum, and to see that their work as surveillance investigators can directly impact the community. This project also provided the HEP staff with phlebotomy training, and an opportunity to make often challenging blood draws. Similarly, this partnership has provided PPP with free HCV confirmatory testing for its clients, a service that is rarely available to this population. The key to the success of this collaboration has been the open dialogue between HEP and PPP, allowing both parties to share feedback, address concerns, and discuss any protocol changes.
While we have not conducted our own cost-benefit analysis, it is clear that early identification of HCV cases, along with regular follow-up and treatment, is preferred over late-stage diagnosis. The health care burden of caring for patients with cirrhosis and liver cancer is quite immense.
This program is sustainable as long as there is some fiscal support for HCV testing. In the event that the Health Department can no longer cover the costs of running the tests, PPP has worked diligently to find other sources of funding from HIV grants or pharmaceutical companies that have new HCV mediations available and are thus motivated to promote testing. Seeing firsthand how beneficial this program has been to its clients has inspired PPP to have its own staff phlebotomy trained and to offer confirmatory testing more than once a week. Beginning in 2015, PPP will pilot another testing day and will coordinate the hand delivery of blood samples to PDPH for testing.