Hepatitis C Clinical Trial
— DRIVE-COfficial title:
Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam
Verified date | October 2023 |
Source | ANRS, Emerging Infectious Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 979 |
Est. completion date | December 30, 2022 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Vietnam | Viet Tiep Hospital | H?i Phòng | |
Vietnam | Hai Phong University of Medicine and Pharmacy | Hai Phong |
Lead Sponsor | Collaborator |
---|---|
ANRS, Emerging Infectious Diseases |
Vietnam,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of all patients in success of the model of care | Proportion of patients with HCV RNA < 15 IU/mL at the end of the study among patients who have signed the informed consent. | Week 48 | |
Secondary | Proportion of patients with detectable HCV RNA | Proportion of patients with HCV RNA > 15 IU/mL among those with positive HCV Ab | Screening pre-inclusion | |
Secondary | Proportion of patients enrolled in care | Proportion of patients with HCV RNA > 15 IU/mL who attended the pre inclusion visit at HCV clinic among those with hepatitis C infection; | Pre-inclusion visit | |
Secondary | Proportion of patients initiating DAA treatment | Proportion of patients who initiate the treatment among patients enrolled in care and eligible for treatment | Initiation treatment visit | |
Secondary | Proportion of patients cured | Number of patients with HCV RNA < 15 IU/mL among those initiating the treatment eligible | Week 24 | |
Secondary | Rate of reinfection | Number of patients with HCV RNA = 15 IU/mL at the end of the study among cured patients | Week 48 | |
Secondary | Rate of mortality | Rate of deaths among all participants with hepatitis C infection | Week 48 | |
Secondary | Frequency, type and time to grade 3 or 4 adverse clinical or biological events. | All adverse events will be graded according to the ANRS adverse events grading table | Week 48 | |
Secondary | Frequency, type and time to drug-related clinical or biological adverse reactions | All drug-related clinical or biological adverse reactions of grade 3 or 4 or leading to treatment interruption | Week 48 | |
Secondary | Adherence assessment | Self-questionnaire on DAA drug intake and drug accountability for DAA | Week 12 | |
Secondary | Factors associated with HCV treatment failure | Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors | Week 24 | |
Secondary | Factors associated with HCV reinfection | Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors | Week 48 | |
Secondary | Effect of the HCV treatment intervention | Estimation of the impact of the intervention on HCV infections and DALYs averted, QALYs saved, HCV incidence and prevalence as projected by the model under various scenarios | Week 48 | |
Secondary | Incremental cost-effectiveness ratio (ICER) | Estimation of the mean ICER which will be compared against standard thresholds for intervention's being cost-effective in LMIC settings | Week 48 |
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