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Rapid hepatitis C test and treat with peer support at opioid treatment programs (RAPID HCV): a hybrid effectiveness-implementation type 1 randomized control trial
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Download the PDF here
Download the PDF here
We conducted an effectiveness-implementation hybrid type 1 trial which utilized a randomized control trial design to primarily evaluate clinical effectiveness of an onsite HCV test-and-treat model delivered within OTPs, while simultaneously assessing implementation outcomes relevant to real world adoption, implementation and sustainability.15
At Baltimore, San Francisco, Toronto and Birmingham, Alabama.
Onsite HCV test and treat with peer support delivered by OTP staff significantly increased HCV treatment initiation (89% vs 21%) compared with offsite referral, and signficantly improved SVR rates. Integrating HCV care into OTPs is an effective strategy to advance HCV elimination among PWUD. The HCV cure rate of 68% of participants who initiated treatment in the OTP arm is similar to that reported in other pragmatic studies of HCV treatment among PWUD in the United States for which lack of assessment of post-treatment HCV RNA due to loss to follow-up is defined as non-response.26,27 The lower HCV cure rates among PWUD with multiple social vulnerabilities in our study are likely multifactorial, including lack of confirmation of HCV response, lower rates of treatment completion, and higher rates of HCV reinfection. In our trial, treatment completion was 71%, like the 74% rate observed in the afore mentioned US telemedicine study.
OTPs are uniquely positioned to meet the needs of PWUD, many of whom have multiple social disadvantages that may make it challenging to navigate the complexities of a fragmented health care system. Among participants in the RAPID HCV study, a significant proportion had ongoing drug use, food insecurity, homelessness and less than a high school education. These characteristics have all been associated with lower rates of HCV treatment uptake due to transportation barriers, challenges navigating complex health care settings compounded by limited health literacy and competing priorities.6 Of note, the specialists involved in this trial all have experience working with marginalized populations of PWUD and still had very low treatment initiation rates with referral to their specialist care settings, highlighting the critical importance of colocation of HCV care with other services.
Additionally, 14% of treatment completers had detectable HCV RNA at the time of the SVR assessment which is higher than expected for individuals with high treatment completion rates, suggesting HCV reinfection caused post-treatment viremia, not treatment nonresponse. This possibility is further supported by high rates of ongoing substance use including recent injecting drug use in the preceding 30 days (75% of participants without documented SVR).
OTPs offer medications for opioid use disorder such as methadone and buprenorphine and other services including peer support and care management with community referrals. OTP service availability is largely influenced by state and federal financing policies including bundle service requirements for receipt of payments for most OTPs.12 Across OTPs, methadone is dispensed with medication intake directly observed at the OTP as frequently as daily with some OTP clients able to take methadone doses home for unobserved intake.12 To support comprehensive care for PWUD, SAMHSA guidelines recommend testing for blood borne infections such as HIV and HCV and highlight the suitability of OTPs for HCV testing and treatment.12
Treatment initiation
In the RAPID HCV arm, 59/66, 89% (95% CI [79-95]) of participants initiated HCV treatment within 12 weeks compared to 12/56, 21% (95% CI [13-34]) in the referral arm, RD 68% (95% CI; 55%-81%), adjusted odds ratio (AOR) 30.79 [95% CI 11.22-84.49], p-value <0.001.
RAPID HCV arm
Participants randomized to the RAPID HCV arm were informed that HCV treatment evaluation and treatment was available on-site and assigned a trained peer mentor. OTP nurses with oversight from a nurse practitioner/physician assistant, MD/DO evaluated patients. HCV treatment was prescribed by OTP clinicians at their discretion. Peer mentors were expected to meet and engage with participants in the RAPID HCV arm weekly from randomization through assessment of sustained virologic response (SVR) at week 12, or 12 weeks after randomization if participants did not initiate HCV treatment. Peer mentors provided information to support HCV treatment uptake, treatment adherence after initiation and reinfection prevention after treatment completion.
Referral arm
Participants randomized to the referral arm were referred to the local offsite specialist HCV treatment center and given a number to schedule an HCV treatment evaluation appointment. Appointments were facilitated by research staff who coordinated with specialist clinic sites to ensure scheduling within 2 weeks if the participant called the appointment scheduling number.
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