Clinical trial NCT03895294: Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia
Official title: Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Keywords: Direct-Acting Antivirals
Health Services Accessibility
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Access to treatment
timeFrame: 2 months
Secondary outcomes:
measure: Opportunity at the start of treatment
timeFrame: 2 months
measure: Effectiveness
timeFrame: 6 months
measure: Drug-related problem
timeFrame: 6 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Medicarte
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Mónica Ledezma, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia
name: Pedro Amariles, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Antioquia
name: Andrea Salazar, PhD
role: STUDY_CHAIR
References: