NCT02363517

The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach

The Treatment And Prevention (TAP) Study: Treating People Who Inject Drugs (PWID) in Community-based Settings Using a Social Network Approach

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the 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 combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a social network-based approach to reduce HCV incidence among PWID.

Detailed description

This study will investigate the 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 combination of sofosbuvir plus ledipasvir (SOF + LDP). It will also measure the effectiveness of using a social network-based approach ("bring your friends") to reduce HCV incidence among PWID. Participants will initially be sourced from the Burnet Institute's existing SuperMIX cohort (N= 757). This cohort comprises PWID followed for between two and six years (median=1057 days), of whom 299 have chronic HCV infection. The HCV genotype distribution in the SuperMIX cohort is: HCV-1 (55%); HCV-3 (40%) and HCV-6 (\<5%). Participants will be randomly allocated to three groups: Group 1: Primary (n=40) and secondary (n=100) participants will receive supportive care only. Group 2: Primary participants (n=40) will be treated with SOF + LDP for 12 weeks. Secondary participants (n=100) will receive supportive care only. Group 3: 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 with SOF + LDP for 12 weeks. Treatment participants will have a clinical review, questionnaire and blood sample collected at baseline, weeks 4, 8 and 12 (end-of-treatment), and at weeks 12 (SVR12), 24 (SVR24), 36, 48, 60 and 72 post-treatment. Non-treatment participants will have a clinical review, questionnaire and blood sample collected at baseline and weeks 12, 24, 36, 48, 60, 72 and 84.

Conditions

• Hepatitis C
• Drug Abuse, Intravenous

Interventions

Type	Name	Description
DRUG	Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)	SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2015-02-16
• Last updated: 2018-04-10

Locations

1 site across 1 country: Australia