A key focus of the study is hepatitis C, but HIV and hepatitis B are also included. The target population includes people who currently use or inject drugs, those with a history of drug use or injection, and their sexual or life partners. People Who Inject Drugs Hepatitis C HIV, Hepatitis B
Conditions
Interventions
The study regimen consists in a single tablet fixed-dose combination of Sofosbuvir (400 mg) + Velpatasvir (100 mg) taken orally once daily with or without food for 12 weeks.
Experimental Drug
Sponsors
Dreamlopments Foundation
USAID and Global Fund
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male, female, or transgender. 18 years of age or older. Former or active injecting or non-injecting drug user reached by harm reduction services or are referred., OR Sexual or life partner of a current or former drug user reached by HRS or referred. Consenting to participate in the study. Willing to undertake HIV Ab testing, HCV Ab testing, and HBs Ag and Ab testing. Candidates with evidence (written medical/laboratory report) of prior testing (including positive testing) for HIV, HCV, or HBV infection can also enroll in the cohort study.
Exclusion criteria
Exclusion criteria: Inability in the opinion of the study staff to provide an informed consent decision to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| People Who Inject Drug (PWID) who accept HCV, HBV and HIV testing 49 months Propotion,HIV-infected PWID eligible for ART who have initiated ART, remain in care and have HIV suppression a 49 months Propotion,Patients with active HCV infection initiating therapy who achieve Sustained Virological Response (SV 24 weeks Propotion | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of HCV and HIV over the study period among PWID with previous negative testing. 49 months Incidence per 100 person-years,Safety of a community-based approach to treatment and care of HCV for PWID with an all-oral DAA comb 24 weeks Number and proportion of events,Safety of a community-based approach to treatment and care of HIV for PWID. 49 months Number and proportion of events | — |
Countries
Thailand
Contacts
Public ContactNicolas Durier
Dreamlopments
Outcome results
None listed