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Puglia HCV Micro-elimination Program (PHCVM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03923595
Recruitment Status : Unknown
Verified April 2019 by Alessandra Mangia, Casa Sollievo della Sofferenza IRCCS.
Recruitment status was:  Recruiting
First Posted : April 22, 2019
Last Update Posted : January 23, 2020
Information provided by (Responsible Party):
Alessandra Mangia, Casa Sollievo della Sofferenza IRCCS

Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Other: Adherence intervention research

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Puglia HCV Micro-elimination in People With Substance Use Disorders
Actual Study Start Date : November 30, 2019
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Adherence intervention research
    dedicated management

Primary Outcome Measures :
  1. Change of linkage to care and treatment of SUD patients with HCV infection [ Time Frame: 15 months ]
    to link to care a minimum of 80% of those with HCV RNA positive results as in our past experience only 50% of SUD patients positive started treatment in our area.

Secondary Outcome Measures :
  1. Change of discontinuation rates of SUD patients with HCV infection [ Time Frame: 15 months ]
    To reduce the rate of treatment discontinuation for SUD who start treatment, from 3% to 1.5%

Biospecimen Retention:   Samples Without DNA
Serum of patients undergoing HCV treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HCV infected patients subjects with substance use disorders (SUD)

Inclusion Criteria:

  • all consecutive patients from SERD of 18 yrs or older either naive or previously treated including HBsAg positive and HIV positive.

Exclusion Criteria:

  • GFR < 50 ml/min, pregnancy, breast-feeding, cirrhosis of CHILD-PUGH-TURCOTTE B7 o >.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03923595

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Alessandra Mangia Recruiting
San Giovanni Rotondo, Fg, Italy, 71013
Contact: Alessandra Mangia    3393123837   
Sponsors and Collaborators
Alessandra Mangia
Publications of Results:
Other Publications:
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Responsible Party: Alessandra Mangia, Chief of Liver Unit, Casa Sollievo della Sofferenza IRCCS Identifier: NCT03923595    
Other Study ID Numbers: 19
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections