DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to assess the effectiveness of a model of hepatitis C screening and integrated care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam. In a wider perspective, this model linked to mass screening through repeated Respondent Driven Sampling (RDS) surveys, to simplified treatment protocol, and to large community-based support to improve referral to care, retention in care, adherence to treatment and prevention of reinfection, may have the potential to eliminate HCV among PWIDs in this city.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Ribavirin; Sofosbuvir

Criteria

INCLUSION CRITERIA

• Participants of the ANRS 12353/NIDA ROI DA 041978 DRIVE study (age > 18 years; positive urine test for heroin an/o methamphetamine & skin marks of injection ) who either participated to the DRIVE RDS3 survey, or to the HIV-positive and HIV-negative DRIVE cohorts;

• Hepatitis C infection defined by a positive HCV RNA

• Signed informed consent form

EXCLUSION CRITERIA

• Severe associated diseases requiring specific treatment (including all specific AIDS defining illnesses, any severe sepsis, severe decompensated cirrhosis, suspicion of hepatocellular carcinoma);

• Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study including very severe clinical condition;

• Previous history of DAA use;

• Contraindication for treatment with sofosbuvir or daclatasvir;

• For women of childbearing potential i.e. women of childbearing age who are not menopausal, or permanently sterilized or not refraining from sexual activity:

• Pregnancy and breastfeeding

• Refusal to use a contraceptive method

• Renal failure with creatinine clearance ≤ 30 milliliter per minute;

• Person deprived of freedom by a judicial or administrative decision;

• Person who plan to move out from Hai Phong in the next 12 months;

• Person unable to understand the study;