The Treatment And Prevention (TAP) Study will investigate the efficacy and feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy of sofosbuvir and ledipasvir (SOF + LDP).
It will also measure the effectiveness of using a social network-based approach (i.e., ‘bring your friends’) to reduce HCV incidence in injecting populations (including the impact on both primary infection and reinfection).
The TAP Study’s entire sample (N=420) will comprise:
Primary participants: SuperMIX participants (n=120) with HCV infection.
Secondary participants: Injecting partners of primary participants (n=300).
Participants will be randomly allocated to three groups:
Group A: Primary (n=40) and secondary (n=100) participants will receive deferred treatment.
Group B: Primary participants (n=40) will be treated with SOF + LDP for 12 weeks. Secondary participants (n=100) will receive deferred treatment (treatment will be provided at the completion of the study follow up)
Group C: Primary (n=40) and secondary participants with chronic HCV infection (n~50%*100) will be treated with SOF + LDP for 12 weeks. Participants in Group C who have evidence of HCV re-infection will be offered re-treatment for 12 weeks.
Participants will be followed up for 18 months to two years.
Recruitment for the TAP Study is expected to commence in January 2015
For more information on the TAP study, please contact 1800 728 680 or email email@example.com