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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

Tracking Information
First Submitted Date April 18, 2019
First Posted Date April 22, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date November 30, 2019
Estimated Primary Completion Date August 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2019)
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.
Original Primary Outcome Measures
 (submitted: April 18, 2019)
Improvement 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.
Change History
Current Secondary Outcome Measures
 (submitted: April 20, 2019)
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%
Original Secondary Outcome Measures
 (submitted: April 18, 2019)
Reduction 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%
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Puglia HCV Micro-elimination Program
Official Title The Puglia HCV Micro-elimination in People With Substance Use Disorders
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.
Detailed Description

Scientific Rationale: To adhere to the WHO plan of identifying 90% and treat 80% of HCV infected subjects, in several Countries a number of barriers need to be overcome (1). A focused effort from physicians and public administrative authorities is required to increase HCV treatment rates using direct acting antivirals (DAAs). Consequently, methods enhancing the epidemiological impact of HCV treatment using DAAs are of primary importance in order to promote what has been defined as micro-elimination (2). Among populations at high risk of transmission, targeted in the context of developing micro-elimination, people who inject drugs (PWID) and, in general, subjects with substance use disorders (SUD) are particularly important to treat.

In Italy, individuals with SUD including people who inject drugs and subjects taking psychiatric medications or alcoholic excess represent the most important target of HCV micro-elimination. Data provided by the Italian National Institute of Health during 2017, show a decline in the incidence of acute HCV infection with a peak of 0.3 x 100.000 inhabitants among subjects of 25-34 years as a consequence of: recent or ongoing use of intra venous (i.v.) substances; and/or sexual transmission (3). Moreover, in the National Cohort Piter including 9.040 HCV infected subjects, 32% was or is currently using alcohol and about 20% was or is currently using substances (4). Of interest, while alcohol abuse is usually associated with cirrhosis, drug use is associated with any stage of fibrosis. These epidemiological data highlight the need to differentiate and personalize the approach to SUD people. Finally, it is important to mention that a decline in the rate of screening has recently been registered in Italy among subjects followed by Outpatient Services for substance use disorders called SERDS (5-6). Current estimates suggest that, in our region, about 4500 subject using substances are probably HCV infected (6). Although it seems that no more than 10% of regular SERDS patients have not yet been screened for viral infections the rate of unscreened people is increasing among young SERDS patients (7). A high rate of unscreened SUD partners and families has been reported by SERDS specialists in our geographical area (personal communications).

In our real life experience only 50% of SUD patients testing HCV RNA positive agree to be treated due to different reasons including fear of treatment and difficulties in reaching DAAs treatment prescribing centers (8). Furthermore, in recent real world study leaded by our center and involving 20 out of 31 of the authorized prescribing centers in Puglia, we observed a 3% higher rate of treatment discontinuation in this, versus general population (8).

Rapid and cost-effective interventional strategies may favor both diagnosis of unknown cases and access to treatment for eligible patients. In general, training and education for providers, and an increased awareness of new advanced DAAs therapies among key risk populations are activities to strengthen within the Health system. However, in given situations, diversifying services and ensuring geographically and culturally appropriate services may play a key role in increasing the screening-diagnosis-referral-treatment-follow up cascade. It is important to establish upfront, within the heath care physicians, what can be done by different figures: the prescriber gastroenterologist is allowed to prescribe DAA and able to manage patients with a very advanced disease or patients with multiple drug-to-drug interactions; and the specialists working at the SERD are not allowed to prescribe DAA but used to monitor SUD patients and to help them to recover from their disorders.

Hypothesis: In Italy, SERDS are spread over the regional areas. According to the geographical characteristics of Puglia and Molise, the region bordering Puglia to the north, there are peripheral areas either along the cost or in internal mountains not well served by the public transportation. This aspect results in the need of relying on a private car to reach the specialized center where patients can be screened, diagnosed and treated. Fifteen SERDS are present in Northern Puglia and Molise over an area of 7500 Km2 usually served by our Hepatology Unit.

Our hypothesis is that, in addition to the known barriers to care for SUD population, lack of direct and efficient public transport represents a limitation preventing SUD individuals not only from being screened, diagnosed and treated, but also adequately informed on the most recent and highly efficient and safe pan-genotypic regimens with low impact drug to drug interactions. Moreover, the chaotic lifestyle and the poor income conditions of these patients prevent treatment completion due to transportation issue, for those who start treatment.

Primary Objective: the primary aim of this project is to explore our hypothesis by evaluating the impact of intensifying screening, diagnosis, linkage to care and treatment cascade of SUD patients through a dedicated cure program including "ad hoc" transportation.

Secondary aims are: firstly, to increase the awareness on HCV infection and related liver disease through a peer-to-peer educational campaign performed at SERDs in combination with our Unit. (Risk and liver disease outcomes, diagnostic and staging tools and the new DAAs regimens will be explained either to patients or to local healthcare workers and nurses at each individual SERD). Secondarily, to reduce treatment discontinuation in the subgroup of PWID patients.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Serum of patients undergoing HCV treatment
Sampling Method Probability Sample
Study Population HCV infected patients subjects with substance use disorders (SUD)
Condition Hepatitis C
Intervention Other: Adherence intervention research
dedicated management
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 18, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 21, 2020
Estimated Primary Completion Date August 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 >.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
Administrative Information
NCT Number NCT03923595
Other Study ID Numbers 19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Alessandra Mangia, Casa Sollievo della Sofferenza IRCCS
Study Sponsor Alessandra Mangia
Collaborators Not Provided
Investigators Not Provided
PRS Account Casa Sollievo della Sofferenza IRCCS
Verification Date April 2019