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Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia (HEPCSTRATEGY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895294
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad de Antioquia

Brief Summary:

Hepatitis C is a public health problem and the high cost of the Direct-Acting Antivirals (DAA) is one of the main limitations for treatment worldwide.

In Colombia, the Ministry of Health and Social Protection (MoHSP) has made progress in addressing Hepatitis C problem in order to control the infection and resolve barriers to access to medicines. One of the strategies implemented was the purchase of DAA, in association with the PAHO, and the instauration of the Clinical Pathway for the treatment of chronic hepatitis C.

The implementation of the Clinical Pathway has required the integration of health care processes and the respective report in the health information systems, allowing a high level of control in the monitoring of the Hepatitis C and the subsequent generation of indicators. However, there is limited information on the effects of the strategic purchase and the instauration of the Clinical Pathway on the costs of care, clinical outcomes and the quality of health care for patients with Hepatitis C in Colombia.

The aim of this study is to establish the effect of strategic purchasing and the Clinical Pathway for the treatment of chronic Hepatitis C, in the clinical results, in the general costs and quality of health care of Hepatitis C patients in Colombia.


Condition or disease Intervention/treatment Phase
Hepatitis C Other: Health care under the strategic purchase-Clinical pathway Other: Usual care process prior strategic purchase-clinical pathway Not Applicable

Detailed Description:

A quasi-experimental design with a non-equivalent control group will be performed, where there will be an intervention group and a control group formed naturally before the investigation. In order to reduce the possible selection bias due to the lack of randomization, the propensity score method will be used. 62 patients will be included in each arm.

An estimation and comparison of the direct costs of the care of patients with Hepatitis C, before and after the implementation of the strategic purchase and the Clinical Pathway will be made, using a "top to bottom" method.

A questionnaire will be applied to the patients of the intervention group in order to identify barriers and facilitators to Hepatitis C health care and patient satisfaction with health care process under the Clinical Pathway.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Health care under the strategic purchase-Clinical pathway
Health care under the strategic purchase and the Clinical pathway for the treatment of chronic Hepatitis C
Other: Health care under the strategic purchase-Clinical pathway
1) purchase of DAA by the MoHSP; 2) diagnosis of the patient (confirmed by quantitative HCV RNA test); 2) prescription of the treatment by a specialist in internal medicine, hepatology or Infectious disease; 3) daily supervised drug administration by a nurse or weekly treatment dispensing by pharmacist; 4) Pharmaceutical Care (includes: consultation with pharmacist at weeks 0, 4, week of the end of treatment (8, 12 or 24) and week of evaluation of effectiveness (week 12 or 24 after the end of treatment); health education and administrative support. In case of identifying any Drug-related Problem, the respective pharmaceutical intervention was made.

Active Comparator: Usual care process prior strategic purchase-clinical pathway
Usual care process prior to the establishment of the strategic purchase and the Clinical Pathway
Other: Usual care process prior strategic purchase-clinical pathway
1) diagnosis of the patient (confirmed by quantitative HCV RNA test); 2) prescription of the treatment by a specialist in hepatology; 3) weekly treatment dispensing by pharmacist; 4) patient use; 5) Pharmaceutical Care (includes: consultation with pharmacist at weeks 0, 4, 8, week of the end of treatment (12 or 24) and week of evaluation of effectiveness (week 12 or 24 after the end of treatment); health education and administrative support). In case of identifying any Drug-related problem, the respective pharmaceutical intervention was made.




Primary Outcome Measures :
  1. Access to treatment [ Time Frame: 2 months ]
    Proportion of patients who initiates treatment, in comparison with the total number of patients with indication of treatment (confirmed diagnosis and prescription of treatment).


Secondary Outcome Measures :
  1. Opportunity at the start of treatment [ Time Frame: 2 months ]
    The difference in days between the date of the first prescription of the antiviral treatment and the start date.

  2. Effectiveness [ Time Frame: 6 months ]
    Proportion of treated patients that achieved Sustained Virological Response (SVR), that is, undetectable HCV viral load (lower than the Lower Quantification Limit -LL-), 12 weeks after the end of the DAA therapy (SVR12) or 24 weeks after the end of treatment for the schemes that include interferon (SVR24)

  3. Drug-related problem [ Time Frame: 6 months ]
    Proportion of patients who initiated treatment and who presented at least one Drug-Related Problem registered in the clinical history, database and / or pharmacovigilance reports.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with Chronic Hepatitis C confirmed by quantitative HCV RNA test
  • Patient affiliated to the contributory system of one Health Promoting Enterprise from Colombia.
  • Patients with prescription of pharmacological treatment for Hepatitis C.

Exclusion Criteria:

  • Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895294


Contacts
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Contact: Pedro Amariles, PhD +5742195476 pedro.amariles@udea.edu.co

Locations
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Colombia
Medicarte Recruiting
Medellín, Antioquia, Colombia
Contact: Natalia Duque, Msc       nduque@medicarte.com.co   
Sub-Investigator: Julieth Gómez, Pharmacist         
Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Mónica Ledezma, Msc Universidad de Antioquia
Study Director: Pedro Amariles, PhD Universidad de Antioquia
Study Chair: Andrea Salazar, PhD Universidad de Antioquia
Additional Information:
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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03895294    
Other Study ID Numbers: Universidad de Antioquia
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Antioquia:
Direct-Acting Antivirals
Health Services Accessibility
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic