New York, USA
This “accessible care” hepatitis C treatment program was designed as a low-barrier approach for people who use drugs. The program was based out of a community harm reduction site in New York City, the Lower East Side Harm Reduction Center (LESHRC). Hepatitis C clinical care was integrated entirely on site, with a focus on flexible appointments and non-stigmatizing care. This model engaged significantly more people in care, curing 67% of participants, compared with an existing patient navigation program, which cured only 23%. This study demonstrates the importance of hepatitis C care that is flexible, non-stigmatizing and integrated with existing services to meet the needs of people who use drugs.
This accessible care hepatitis C treatment program was based out of the LESHRC. The centre provides drug use equipment, overdose prevention training, substance use treatment, HIV and hepatitis C screening, and other harm reduction services. The program was designed as a low-threshold, “accessible” hepatitis C treatment program where all services were delivered on site.
Participants were recruited through community-based organizations that serve people who use drugs. They were prescreened via telephone or in person at various locations around New York, including LESHRC. Those with a confirmed hepatitis C diagnosis, who had injected drugs for at least one year and who reported injecting drugs at least once in the last 90 days were eligible for the program. For people who required hepatitis C testing, the program provided free hepatitis C antibody screening tests and confirmatory polymerase chain reaction (PCR) tests at LESHRC. Individuals who were pregnant or had advanced liver disease were referred outside the program.
Integrated, flexible and non-stigmatizing care
The accessible care hepatitis C treatment program was developed based on harm reduction values, and it supported participants whether they were actively using drugs or not. Staff focused on delivering friendly, informal and non-judgmental care to reduce stigma and on supporting their clients to achieve their personal health goals.
Participants attended medical appointments entirely within LESHRC with a prescribing physician. The program provided flexible scheduling, including drop-in appointments, and engaged in proactive outreach for missed visits. Treatment medication was provided at LESHRC, and participants could choose a daily, weekly or monthly dispensing schedule.
On-site care coordinators helped participants to navigate the process of applying for insurance coverage or drug assistance programs, and they provided support for treatment adherence, hepatitis C and harm reduction education, and connection to other social services. All participants who completed treatment were offered on-site reinfection prevention support and training and offered ongoing testing for reinfection every three months.
Incentives and payment
Participants were given cash incentives throughout the program, including for taking part in a visit by researchers every three months, after one year of enrolment in the study and for attending an appointment 12 weeks after treatment to confirm cure (sustained virologic response).
This study compared the accessible care program with an existing “usual care” program. In the usual care model, participants were referred to a hepatitis C patient navigator, as part of a city-run Check Hep C program. The navigator provided support services including referral to hepatitis C providers, accompaniment to appointments, support with adherence, hepatitis C education and assistance accessing insurance coverage. The major differences were that this program required individuals to seek care in the community instead of integrated care at LESHRC.
Between July 2017 and March 2020 (34 months), 572 participants were assessed for eligibility with 167 meeting all study criteria. The main reasons for ineligibility included incomplete test results, no injection drug use in the past 90 days and a lack of chronic hepatitis C infection. A total of 165 patients started treatment and were randomly assigned to the accessible care program (82 participants) or the usual care program (83 participants). Demographic characteristics were consistent across the two groups, with the exception of a higher rate of recent incarceration in the usual care group (12%) versus the accessible care group (2.4%).
Overall, those assigned to the accessible care group had much higher cure rates (sustained virologic response at 12 weeks after treatment); 67.1% of participants in the accessible care group were cured, versus 22.9% in the usual care group. This was due to participants in the accessible care group being significantly more likely to complete earlier steps of the care cascade than those in the usual care group:
- 92.7% versus 44.6% were referred to a hepatitis C clinician
- 86.6% versus 37.4% of those referred, attended an initial clinical appointment
- 86.6% versus 31.3% completed required laboratory testing
- 78.0% versus 26.5% initiated treatment
The cure rates among those who completed treatment in the two groups were similar (approximately 86%). This indicates that the differences were due to the differences in the rate at which people were engaged in care, and that treatment medication was equally effective in both groups. These differences across the care cascade were observed regardless of differences in demographic factors, including homeless status, prior hepatitis C treatment and daily injection drug-use. No patient in either group was denied coverage by their insurance provider.
Of the 55 participants in the accessible care group who were cured, four were reinfected during 57.9 patient-years of follow-up. This resulted in a reinfection rate of 6.9 per 100 patient-years. Patient-years is a statistic to express reinfection risk on the basis of the total amount of time that researchers followed all 55 participants after cure.
What does this mean for service providers?
To achieve Canada’s hepatitis C elimination goals, we need programs that can reach people who use drugs and tailor services to effectively engage them in care. This study demonstrates the impact of on-site hepatitis C care that is integrated into existing harm reduction services. This, in combination with care from trusted providers in familiar, non-stigmatizing settings, makes it more likely that individuals will engage in care. When offered care that caters to their needs, people who use drugs can successfully complete treatment with high cure rates.
It’s notable that the usual care model can be considered a “low-threshold” model, with a patient navigator who provided one-to-one support. However, it may be that seeking care and attending appointments with unfamiliar providers in traditional health care environments is still an insurmountable barrier for many.
This study also points to a greater opportunity to integrate hepatitis C care into other services for people who use drugs. The authors noted that 70% of untreated participants had regular engagement with opioid agonist therapy. There may be a missed opportunity for these and other harm reduction programs to integrate hepatitis C care, which is a proven approach to reach people who use drugs.
- Hepatitis C treatment in harm reduction programs for people who use drugs (CATIE)
- Check Hep C evidence brief (CATIE)
- Integration of hepatitis C care into community drug and alcohol clinics (CATIE)
- Hepatitis C treatment integrated in the Malmö Needle Exchange Program (CATIE)
Eckhardt B, Mateu-Gelabert P, Aponte-Melendez Y et al. Accessible hepatitis care for people who inject drugs: A randomized clinical trial. JAMA Internal Medicine. 2022;182(5):494-502.