Élimination du virus de l'hépatite C chez les usagers de substances (EHCUS)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Graciela Castro-Narro, MD
- Numéro de téléphone: +52 55 5405 3670
- E-mail: gracastron@yahoo.com
Sauvegarde des contacts de l'étude
- Nom: Valeria Cortés-Mollinedo, MD
- Numéro de téléphone: +52 27 1100 7484
- E-mail: vale.crts.mllnd@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
1 tab every 24 hrs for 12 weeks
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sustained viral response (SVR) in people who use substances in the Mexico City metropolitan area and the northern states of the country.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Seroprevalence and prevalence of HCV in people who use substances in the Mexico City metropolitan area and the northern states of the country.
Délai: 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
Délai: through study completion, an average of 1 year
|
Number of participants who does not achive RVS |
through study completion, an average of 1 year
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Graciela Castro-Narro, MD, INCMNSZ
Publications et liens utiles
Publications générales
- Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014.
- Mendizabal M, Alonso C, Silva MO. Overcoming barriers to hepatitis C elimination. Frontline Gastroenterol. 2019 Jul;10(3):207-209. doi: 10.1136/flgastro-2018-101114. Epub 2019 Feb 1. No abstract available.
- Lazarus JV, Safreed-Harmon K, Thursz MR, Dillon JF, El-Sayed MH, Elsharkawy AM, Hatzakis A, Jadoul M, Prestileo T, Razavi H, Rockstroh JK, Wiktor SZ, Colombo M. The Micro-Elimination Approach to Eliminating Hepatitis C: Strategic and Operational Considerations. Semin Liver Dis. 2018 Aug;38(3):181-192. doi: 10.1055/s-0038-1666841. Epub 2018 Jul 9.
- Wansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.
- Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Int J Surg. 2014 Dec;12(12):1500-24. doi: 10.1016/j.ijsu.2014.07.014. Epub 2014 Jul 18.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GAS-3800-21-22-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
all IPD that underlie results in a publication would be shared
Délai de partage IPD
By 2024, once the enrollment of patients and the analyzes have been completed, this publication will be published and can be consulted
Critères d'accès au partage IPD
An Open Access journal will be searched so that the information can be consulted
Type d'informations de prise en charge du partage d'IPD
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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