Increasing HCV Linkage to Care Among People Who Inject Drugs

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741750
• Other study ID #: GSHCV
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Family Health Centers of San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Other:
• Simplified HCV care within a mobile medical unit
Delivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit

Locations

Country	Name	City	State
United States	Family Health Centers of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Family Health Centers of San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who initiate HCV treatment	Initiating treatment with a Direct-Acting Antiviral (DAA)	6 months of follow-up
Secondary	Number of patients who complete HCV treatment	Completing a full treatment course of 8 or 12 weeks of DAA therapy	16 weeks after treatment initiation
Secondary	SVR12 rates	Undetectable HCV RNA on or after the SVR12 time point	At least 12 weeks following DAA completion
Secondary	Initiation rates for medication-assisted treatment (MAT) for Opioid Use Disorder	Attendance of at least one visit to a community clinic for treatment of Opioid Use Disorder	During the first 3 months of follow-up after enrollment
Secondary	Persistent rate for MAT	> 3 visits for MAT	During 6 months of follow-up after enrollment
Secondary	Number of patients who receive abscess care	Treatment for skin infection or abscess	During 6 months of follow-up after enrollment
Secondary	Prevalence of engagement in care	The number of visits for any reason during the study period	During 6 months of follow-up after enrollment