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Increasing HCV Linkage to Care Among People Who Inject Drugs

Does a Simplified Algorithm and Integrated HCV Care Improve Linkage to Care, Retention, and Cure Among People Who Inject Drugs? A Pragmatic Quality Improvement Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04741750
Enrollment
200
Registered
2021-02-05
Start date
2021-02-02
Completion date
2023-09-30
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, Hepatitis C treatment, People who inject drugs, Mobile medical clinic, People experiencing homelessness, Treatment initiation, Linkage to care, Quality improvement

Brief summary

Our study will test the effectiveness of a simplified approach to delivering Hepatitis C Virus (HCV) care in a street-based mobile medical clinic among people who inject drugs in increasing treatment initiation, retention, and cure. Rates of HCV treatment initiation, retention, and cure will be compared between patients offered the simplified approach to delivering HCV care in a mobile medical clinic versus those who are linked to a community clinic delivering a current practice of usual care. The investigators hypothesize that the simplified approach to delivering HCV care in a street-based mobile medical clinic will result in higher treatment initiation, retention, and cure than the current practice of usual care in community clinics.

Detailed description

With as many as 2.4 million Americans affected by chronic Hepatitis C Virus (HCV), it is one of the most common blood-borne diseases in the United States. Nationwide, rates of new infections have risen dramatically among young adults in their 20s and 30s, the same cohorts most affected by the opioid epidemic, with as many as 70% of new infections related to injection drug use. Local/regional rates of new infection mirror these national surveillance findings. In San Diego, between 2011 and 2016, women aged 20-29 experienced a 62.2% increase in new HCV infections, while new infections among men aged 20-29 spiked 46.6%, with injection drug use cited as the most common form of transmission. Expanded prevalence estimates indicate a population prevalence rate for HCV of 2.0% to 2.7% in San Diego County, suggesting that approximately 65,000 to 88,000 individuals in the region are likely HCV-infected. These alarming increases in new HCV infections demand effective treatment delivered to populations that historically have been difficult to reach and are characterized by disparities in HCV screening, linkage to care, and treatment access due to a constellation of barriers to care. Advances in HCV treatment and care (e.g., the development of highly effective direct-acting antivirals--DAAs) show promise for treating these populations and have led to worldwide HCV elimination goals, as well as local/regional elimination campaigns. While the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA)'s guidelines have long been considered the gold standard for HCV diagnosis, workup, and treatment (and remain appropriate for HCV specialists, especially in complex cases of HCV infection) recent World Health Organization (WHO) HCV guidelines and published consensus statements call for implementation of streamlined and simplified algorithms for HCV care, delivered in an integrated primary care setting. They highlight that most patients, particularly younger people who inject drugs (PWID), have a low risk of cirrhosis, do not require genotyping if treated with pangenotypic regimens, and may be lost to follow-up due to overly complex, time-intensive, and costly evaluations. Furthermore, emerging evidence indicates that PWID achieve the same high cure rates as non-injection drug user patients when treated with DAAs. While research indicates that DAAs have high efficacy and safety and can now be used by primary care providers to treat HCV there are still groups, especially PWID, who experience treatment disparities due to access and treatment barriers. Limited evidence exists to support the effectiveness of expanding screening and treatment access via the use of mobile medical clinics co-located with services for PWID. Only one study to date has shown that point of care testing in a mobile medical clinic resulted in significantly higher rates of HCV infected patients being linked to HCV treatment in 30 days compared to standard phlebotomy HCV testing. Therefore, the proposed study will test the effectiveness of a simplified HCV algorithm with integrated care (including the offer of buprenorphine prescriptions and abscess care), in a street-based mobile clinic setting among PWID, in increasing treatment initiation and retention rates. Rates of HCV treatment initiation and retention will be compared between patients offered a simplified HCV care in a mobile medical clinic versus those who are linked to the current practice of usual care in community clinics.

Interventions

OTHERSimplified HCV care within a mobile medical unit

Delivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit

Sponsors

Family Health Centers of San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Allocation is concealed until intervention is assigned. The PI and those analyzing the outcome of the trial will remain blinded throughout the entirety of the study. Only the patients and those delivering the intervention will be aware of the allocation.

Intervention model description

A pragmatic quality improvement randomized controlled trial will be conducted among 200 people who inject drugs (PWID) with chronic hepatitis C virus (HCV), age ≥18 years, recruited from Family Health Centers of San Diego's mobile clean syringe exchange program (CSEP). Patients will be recruited to undergo HCV testing. Patients with a positive HCV Ab rapid finger stick test will be randomly allocated (ratio 1:1) to receiving treatment immediately in a mobile medical clinic (n=100) or in a community clinic (n=100, this will serve as a concurrent control group).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be positive HCV antibody and positive HCV RNA patients aged 18 years or older who are willing to undergo HCV treatment.

Exclusion criteria

There are no

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who initiate HCV treatment6 months of follow-upInitiating treatment with a Direct-Acting Antiviral (DAA)

Secondary

MeasureTime frameDescription
SVR12 ratesAt least 12 weeks following DAA completionUndetectable HCV RNA on or after the SVR12 time point
Initiation rates for medication-assisted treatment (MAT) for Opioid Use DisorderDuring the first 3 months of follow-up after enrollmentAttendance of at least one visit to a community clinic for treatment of Opioid Use Disorder
Number of patients who complete HCV treatment16 weeks after treatment initiationCompleting a full treatment course of 8 or 12 weeks of DAA therapy
Number of patients who receive abscess careDuring 6 months of follow-up after enrollmentTreatment for skin infection or abscess
Prevalence of engagement in careDuring 6 months of follow-up after enrollmentThe number of visits for any reason during the study period
Persistent rate for MATDuring 6 months of follow-up after enrollment\> 3 visits for MAT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026