Elimination of Hepatitis C Virus Among Users of Substances (EHCUS)

September 27, 2022 updated by: Graciela Elia Castro Narro, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Eliminación de la infección Por el Virus de la Hepatitis C en PWID en Los Estados Del Norte de México

Substance users are a vulnerable group that should be prioritized in HCV (Hepatitis C Virus) elimination efforts in Mexico and in which it is feasible to carry out micro-elimination programs. It is an important group to treat both because of its high prevalence and because of the dynamic spread of infection among the general population. HCV seropositivity has not been documented in this group of people in Mexico City, the metropolitan area and the northern states of the country, nor has the sustained viral response been evaluated in this group of patients in the Mexican population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators would use a work team, the program and the value proposal would be presented to the local authorities, the coordinator of the national commission against dependencies and doctors. The investigators would use an algorithm designed for the first-step diagnosis of HCV in SUs (Substances Users) , and defined the key centers for screening and linking to care.

The project is planned as follows:

  • Screening: SUs in centers of substance users in Mexico City, the metropolitan area and states in the North of the country will be evaluated with rapid tests. Those with a positive result will be selected.
  • Diagnosis: Patients with a positive rapid test result will undergo a viral load test against HCV. Those with positive results will be selected.
  • Link-up: Those who are confirmed positive will be profiled to receive treatment at INCMNSZ. they will receive damage reduction to prevent reinfection or primary infection in negatives (granted by the rehabilitation center).
  • Treatment: The treatment will be received in a certified hospital (INCMNSZ) to treat patients with HCV infection, the treatment will be indicated by doctors who work in this hospital in the treatment consultations for hepatitis C or in centers with substance users with doctors trained to administer the treatment. This training will be received by telementoring. And also during the treatment, follow-up will be given with telementoring sessions if necessary. This group of people has personality characteristics that require a integral treatment, so it will be a integral and multidisciplinary treatment with psychological care and harm reduction (provided by the rehabilitation center)
  • Confirm SVR: A viral load test will be performed 12 weeks after the end of treatment to corroborate SVR. They will be given after this a mentorship for harm reduction and advice against reinfections

The importance of this project is characterized by minimal monitoring, patients and doctors education by telementoring, multidisciplinary teams and integral treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Substances Users who are registered in the rehabilitation centers that comply with the applicable regulations in Mexico City, the metropolitan area and the northern states of the country.

Description

Inclusion Criteria:

  • Patients older than 18 years.
  • Active infection by hepatitis C virus.
  • People who use substances and who are users of rehabilitation centers in Mexico City, the metropolitan area and the northern states of the country.
  • Signature of informed consent

Exclusion Criteria:

  • all those who do not fit the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Substances Users
Substances users confirmed with Viral Load for HCV. after that will be evaluated through laboratory studies (CBC and blood chemistry), HIV/HBV (Hepatitis B Virus) serology, fibrosis status will be evaluated through APRI (AST to Platelet Ratio Index) and FIB-4. The antiviral treatment (sofosbuvir/Velpatasvir) will be chosen according to the characteristics of each patient and follow-up will be maintained according to the national plan with a visit at the end of treatment and 12 weeks after its end to assess SVR. The importance of this project is characterized by minimal monitoring, patients and doctors education by telementoring, multidisciplinary teams and integral treatment.
Drug: Sofosbuvir 400 MG / Velpatasvir 100 MG [Epclusa]
1 tab every 24 hrs for 12 weeks
Other Names:
  • Epclusa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained viral response (SVR) in people who use substances in the Mexico City metropolitan area and the northern states of the country.
Time Frame: through study completion, an average of 1 year
Number por participants who achive SVR whit the treatment
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevalence and prevalence of HCV in people who use substances in the Mexico City metropolitan area and the northern states of the country.
Time Frame: through study completion, an average of 1 year
Number of participants with chronic HCV infection
through study completion, an average of 1 year
No Sustained viral response (SVR) in people who use Substances in the Mexico City
Time Frame: through study completion, an average of 1 year
Number of participants who does not achive RVS
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Graciela Castro-Narro, MD, INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2022

Primary Completion (Anticipated)

August 15, 2023

Study Completion (Anticipated)

May 15, 2024

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 14, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAS-3800-21-22-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication would be shared

IPD Sharing Time Frame

By 2024, once the enrollment of patients and the analyzes have been completed, this publication will be published and can be consulted

IPD Sharing Access Criteria

An Open Access journal will be searched so that the information can be consulted

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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