Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia
HEPCSTRATEGY
Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedJune 7, 2019
March 1, 2019
1.3 years
March 28, 2019
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Access to treatment
Proportion of patients who initiates treatment, in comparison with the total number of patients with indication of treatment (confirmed diagnosis and prescription of treatment).
2 months
Secondary Outcomes (3)
Opportunity at the start of treatment
2 months
Effectiveness
6 months
Drug-related problem
6 months
Study Arms (2)
Health care under the strategic purchase-Clinical pathway
EXPERIMENTALHealth care under the strategic purchase and the Clinical pathway for the treatment of chronic Hepatitis C
Usual care process prior strategic purchase-clinical pathway
ACTIVE COMPARATORUsual care process prior to the establishment of the strategic purchase and the Clinical Pathway
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicarte
Medellín, Antioquia, Colombia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mónica Ledezma, Msc
Universidad de Antioquia
- STUDY DIRECTOR
Pedro Amariles, PhD
Universidad de Antioquia
- STUDY CHAIR
Andrea Salazar, PhD
Universidad de Antioquia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
March 29, 2019
Study Start
April 1, 2019
Primary Completion
July 31, 2020
Study Completion
November 30, 2020
Last Updated
June 7, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share