物質使用者のC型肝炎ウイルス撲滅 (EHCUS)
Eliminación de la infección Por el Virus de la C 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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Graciela Castro-Narro, MD
- 電話番号：+52 55 5405 3670
- メール：gracastron@yahoo.com
研究連絡先のバックアップ
- 名前：Valeria Cortés-Mollinedo, MD
- 電話番号：+52 27 1100 7484
- メール：vale.crts.mllnd@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sustained viral response (SVR) in people who use substances in the Mexico City metropolitan area and the northern states of the country.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seroprevalence and prevalence of HCV in people who use substances in the Mexico City metropolitan area and the northern states of the country.
時間枠：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
時間枠：through study completion, an average of 1 year
|
Number of participants who does not achive RVS |
through study completion, an average of 1 year
|
協力者と研究者
協力者
捜査官
- 主任研究者：Graciela Castro-Narro, MD、INCMNSZ
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GAS-3800-21-22-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
all IPD that underlie results in a publication would be shared
IPD 共有時間枠
By 2024, once the enrollment of patients and the analyzes have been completed, this publication will be published and can be consulted
IPD 共有アクセス基準
An Open Access journal will be searched so that the information can be consulted
IPD 共有サポート情報タイプ
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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