NCT02555475

The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital

The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Prime Study is a randomised trial investigating models of care for hepatitis C in the era of direct acting antiviral (DAA) therapy. The study aims to compare outcomes of hepatitis C care and DAA treatment provided in a primary health care service with a tertiary hospital.

Detailed description

This open label randomised trial will investigate the efficacy of treating people with G1 HCV with DAA in primary healthcare services compared with tertiary hospital clinics. Three hundred and eighty G1 HCV infected patients attending study primary healthcare centres will be invited to participate in the study. At the primary healthcare centre participants will be randomly allocated to two groups: Group 1: (n=190) Following their initial screen, these participants will be referred to a tertiary hospital for transient elastography and DAA treatment (traditional model of care) Group 2: (n=190) Following their initial screen, these participants will be offered transient elastography and DAA treatment delivered at the primary healthcare service only. Treatment will consist of fixed dose combination paritaprevir, ombitasvir and ritonavir packaged together with dasabuvir, known as Viekira Pak, +/- weight based ribavirin. As cirrhotic patients will be excluded from the study, the duration of treatment is 12 weeks.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
OTHER	community based hepatitis C care and treatment

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-12-22
• Completion: 2018-05-22
• First posted: 2015-09-21
• Last updated: 2018-05-24

Locations

8 sites across 2 countries: Australia, New Zealand