Hepatitis CHEPCSTRATEGYNCT03895294
Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia
A study testing Health care under the strategic purchase-Clinical pathway in people with Hepatitis C, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Health care under the strategic purchase-Clinical pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteColombia
- Study dates
- 1 Apr 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Medicarte
Medellín, Antioquia
Natalia Duque, Msc, nduque@medicarte.com.co
Julieth Gómez, Pharmacist
About this study
Official title: Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
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.
Read more
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Health care under the strategic purchase-Clinical pathway, Usual care process prior strategic purchase-clinical pathway
- Keywords
- Direct-Acting Antivirals, Health Services Accessibility
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care under the strategic purchase-Clinical pathwayOther
- 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.
Usual care process prior strategic purchase-clinical pathwayOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Health care under the strategic purchase-Clinical pathway | Experimental | Health care under the strategic purchase and the Clinical pathway for the treatment of chronic Hepatitis C Receives: Other: Health care under the strategic purchase-Clinical pathway |
| Usual care process prior strategic purchase-clinical pathway | Active comparator | Usual care process prior to the establishment of the strategic purchase and the Clinical Pathway Receives: Other: Usual care process prior strategic purchase-clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (3)
Opportunity at the start of treatment
The difference in days between the date of the first prescription of the antiviral treatment and the start date.
Measured: 2 months
Effectiveness
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)
Measured: 6 months
Drug-related problem
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mónica Ledezma, Msc, Principal investigator, Universidad de AntioquiaPedro Amariles, PhD, Study director, Universidad de AntioquiaAndrea Salazar, PhD, Study chair, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895294
- Sponsor's protocol ID
- Universidad de Antioquia
- Acronym
- HEPCSTRATEGY
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
- ClinicalTrials.gov ID
- NCT03895294
- Acronym / sponsor ID
- HEPCSTRATEGY / Universidad de Antioquia
- Conditions
- Hepatitis C
- Keywords
- Direct-Acting Antivirals, Health Services Accessibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care under the strategic purchase-Clinical pathway | Experimental | Other: Health care under the strategic purchase-Clinical pathwayHealth 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 comparator | Other: Usual care process prior strategic purchase-clinical pathwayUsual care process prior to the establishment of the strategic purchase and the Clinical Pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health care under the strategic purchase-Clinical pathway1) 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. | Other | Health care under the strategic purchase-Clinical pathway |
| Usual care process prior strategic purchase-clinical pathway1) 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. | Other | Usual care process prior strategic purchase-clinical pathway |
Primary outcome
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).
3 secondary outcomes
Opportunity at the start of treatment
Time frame: 2 months
Effectiveness
Time frame: 6 months
Drug-related problem
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Clinical pathway for the treatment of chronic Hepatitis C, a look and a complement from the perspective of pharmaceutical servicesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mónica Ledezma, Msc principal investigator
Universidad de Antioquia
Pedro Amariles, PhD study director
Universidad de Antioquia
Andrea Salazar, PhD study chair
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health care under the strategic purchase-Clinical pathway in people with Hepatitis C, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Amariles, PhD (+5742195476, pedro.amariles@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to treatment (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.