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Elimination of Hepatitis C Virus Among Users of Substances

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05503979
Acronym
EHCUS
Enrollment
1000
Registered
2022-08-17
Start date
2022-11-15
Completion date
2024-05-15
Last updated
2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C in Substance Users

Keywords

HCV, Elimination, Substance Users

Brief summary

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.

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

Interventions

DRUGSofosbuvir 400 MG / Velpatasvir 100 MG [Epclusa]

1 tab every 24 hrs for 12 weeks

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sustained viral response (SVR) in people who use substances in the Mexico City metropolitan area and the northern states of the country.through study completion, an average of 1 yearNumber por participants who achive SVR whit the treatment

Secondary

MeasureTime frameDescription
Seroprevalence and prevalence of HCV in people who use substances in the Mexico City metropolitan area and the northern states of the country.through study completion, an average of 1 yearNumber of participants with chronic HCV infection
No Sustained viral response (SVR) in people who use Substances in the Mexico Citythrough study completion, an average of 1 yearNumber of participants who does not achive RVS

Contacts

Primary ContactGraciela Castro-Narro, MD
gracastron@yahoo.com+52 55 5405 3670
Backup ContactValeria Cortés-Mollinedo, MD
vale.crts.mllnd@gmail.com+52 27 1100 7484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026