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Puglia HCV Micro-elimination Program

NCT03923595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 231

Last updated 2021-08-04

No results posted yet for this study

Summary

High rates of HCV infections occur in individuals with Substance Use Disorder (SUD), particularly in subjects with Alcohol Use Disorder and in People Who Inject Drugs (PWID), but also in subjects taking psychiatric medications. In our geographic area, HCV prevalence data are available for PWID only, with \>25% of them infected with HCV. The best strategy to achieve micro-elimination is targeted active screening. In Italy, SERDs assess and manage SUD individuals, but are not allowed to treat patients. Moreover, they have limited resources to perform HCV screening and to ensure linkage to care for SUD individuals living in peripheral areas. Fifteen SERDs are present in Northern Puglia and Molise, a geographical area of about 7500 Km2 usually served by our Hepatology Unit. This geographic area is not very well served by public transport leading to a logistical barrier to access needed services delivered by our unit. This issue can negatively affect engagement with clinical services for viral hepatitis even in the era of DAA. Moreover, during treatment, it is not infrequent for patients to discontinue therapy due to a chaotic lifestyle, poor income conditions and the limited access to public transportation which is needed to adhere to on-treatment monitoring. Primary objective to plan and deliver a program of dedicated transportations and cure for patients with SUD and hepatitis C who live in peripheral areas of our region. It will translate in higher rates of screening, successful linkage to care, commencement and completion of DAA treatments leading to HCV microelimination. We plan to expand our collaborative work involving up to 15 SERDs form Northen of Puglia. The program consists of -peer to peer meetings with SERDs physicians and teams, educational campaigns for patients and screening of SUD individuals and their partners using oral Quick HCV test at each SERD, - dedicated transportation services, - complete virological and liver disease evaluation at our Hospital. This organization will guarantee direct connections between Hospital and patients included in the program. This program will ensure screening of patients with suspected infection at SERD, linkage to care of newly diagnosed subjects and completion of treatment for subjects who need to start DAA therapy. The rate of screening and successful linkage to care for each SUD subgroup will be characterized as well as the cascade to care.

Conditions

  • Hepatitis C

Interventions

OTHER

Adherence intervention research

dedicated management

Sponsors & Collaborators

  • Alessandra Mangia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03923595 on ClinicalTrials.gov