Pilot Trial of Directly Observed Anti HCV Therapy & Contingency Management in a Population on Opiate Substitute Therapy

NCT03483818 | Completed

• 1 other identifier: 2014CO01
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

DOT-C is a cluster randomised trial of a pharmacist-led, directly observed anti HCV therapy pathway versus the conventional care pathway within community pharmacies. The primary trial outcome is to evaluate the effect of pharmacist-led anti-HCV directly observed therapy on the proportion of patients reaching a sustained virological response.

Conditions

Hepatitis C

Keywords

Community Pharmacy; Antiviral Therapy

Outcome Measures

Primary Outcomes (1)

• The number of patients reaching a sustained virological response in the pharmacist -led arm, as compared with the current treatment pathway for patients receiving opiate substitution therapy

  Participants who complete the pathway and undertake a test for viral clearance

  Sustained Virological response will be assessed at 12 weeks post completion of therapy

Secondary Outcomes (2)

• Cost effectiveness of the pharmacist DOT pathway as compared with the conventional care pathway

  One Year post trial completion

• Comparison of rate of HCV testing rates in pharmacist pathway compared with current pathway

  Sustained Virological response will be assessed at 12 weeks post completion of therapy

Study Arms (2)

Pharmacist-Led Pathway

ACTIVE COMPARATOR

Assessment \& Treatment of HCV infection with oral antivirals in a community pharmacy pathway

Procedure: Assessment & Treatment of HCV infection with oral antivirals

Conventional Care Pathway

ACTIVE COMPARATOR

Assessment \& Treatment of HCV infection with oral antivirals in a conventional care pathway

Procedure: Assessment & Treatment of HCV infection with oral antivirals

Interventions

Assessment & Treatment of HCV infection with oral antivirals PROCEDURE

This is a cluster randomised trial of directly observed anti HCV therapy versus conventional care in HCV positive patients, who are in a pharmacist delivered OST program, where the patients attending an individual pharmacist are the cluster. Pharmacies participating in the trial will be allocated to conventional care pathway or the pharmacist-led pathway.

Conventional Care Pathway; Pharmacist-Led Pathway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV PCR positive to genotype 1
• On Opioid Substitution Therapy dispensed and with supervised administration by pharmacist

You may not qualify if:

• HCV PCR positive to any genotype other than genotype 1
• Evidence of current or previous decompensated liver disease
• HIV infection
• HBsAg positive with detectable HBV DNA
• Aggressive or violent behaviour
• Inability to provide informed consent
• Pregnancy or breast feeding

Sponsors & Collaborators

• NHS Tayside: lead
• University of Dundee: collaborator

Study Sites (1)

Ninewells Hospital

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (1)

• Radley A, Tait J, Dillon JF. DOT-C: A cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy. Int J Drug Policy. 2017 Sep;47:126-136. doi: 10.1016/j.drugpo.2017.05.042. Epub 2017 Jun 21.

  PMID: 28647161 RESULT

Related Links

• Publication of study outcomes

MeSH Terms

Conditions

Hepatitis C

Interventions

Restraint, Physical; Antiviral Agents

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• John Dillon

  NHS Tayside

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a feasibility study comparing delivery of care pathways rather than evaluating medication

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: March 30, 2018
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 30, 2018

Record last verified: 2017-12

Locations

GB (1)