- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03071315
Economic Evaluation Comparing CCT With MMT in Hai Phong City, Vietnam
Economic Evaluation Comparing Center-based Compulsory Drug Treatment With Community-based Methadone Maintenance Treatment in Hai Phong City, Vietnam
Study Overview
Detailed Description
The study compared the effectiveness and cost-effectiveness of two dominant heroin dependence treatment approaches: center-based compulsory rehabilitation (CCT) and community-based voluntary methadone treatment (MMT) in Hai Phong City, Vietnam. CCT centers are institutions in which people who use drugs are confined for two years. MMT has been internationally recognized as an efficacious treatment for heroin dependence and was introduced in Vietnam in 2008.
The design was combined retrospective and prospective, non-randomized cohort over three years (with data at five time-points). The study was conducted between 2012 and 2014, involving 208 CCT participants (of which 80% were followed up) and 384 MMT participants (of which 78% were followed up) with heroin dependence. The five time-points were: baseline, two years after treatment commencement, then three months, six months and 12 months after the initial two years. The study combined primary data and secondary data to assess the effectiveness of the two treatment modalities. The economic component measured the costs of the two treatment modalities to compare cost-effectiveness outcomes.
The study had two primary outcomes: self-reported heroin abstinence (confirmed by urine drug screening) and self-reported drug-free days (DFDs). DFDs was reported in two different time-frames. DFDs in the preceding 30 days was used for effectiveness comparison and DFDs over three years was used for the cost-effectiveness comparison. The study has four secondary outcomes: illegal behaviors, overdose, blood-borne virus (BBV) risk behaviors, and monthly drug spending).
Mixed effects regression models were used to analyze the effectiveness data and non-parametric bootstrapping methods were used to estimate cost-effectiveness. The time-frame for the cost-effectiveness analysis was three years.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hai Phong, Vietnam, 10000
- Study site in Vietnam
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
CCT Participants: Participants who were placed in three CCT centers in Hai Phong City for 2 years (2011-2013) and agreed to voluntarily participate in this study (from July 2013: 12 months community follow-up).
MMT Participants: Participants who have participated in a previous cohort study (two-years:2009-2012) and agreed to voluntarily participate in this study (from 2013: an addition of 12 months)
Description
Inclusion Criteria (for CCT Participants):
- 18 years of age and older
- Heroin dependent
- CCT-released participants who were rehabilitated in the CCT centers under the compulsory track.
- CCT-released participants who received the recruitment letter sent by CCT centers' staff and who could provide either the recruitment letter or a certificate of CCT treatment completion at the time of first contact with a researcher as a proof that they were newly CCT-released participants.
- Consented voluntarily to participate in the study, as assessed and determined by the researcher providing the informed consent documentation.
Exclusion Criteria (for CCT Participants):
- Younger than 18 years old
- Severe cognitive or mental impairment
- Unable to grant consent for this research study
- Non-dependent use of heroin.
Inclusion Criteria (for MMT Participants):
- 18 years of age and older
- Heroin dependence, measured by self-reported daily use of heroin during 3 months prior to index treatment, a proxy to measure heroin dependence
- Participated in MMT treatment in Hai Phong City from 2008-2009
- Consented voluntarily to participate in this research, as assessed and determined by the researcher providing the informed consent documentation.
Exclusion Criteria (for MMT Participants):
- Younger than 18 years old
- Severe cognitive or mental impairment
- Unable to grant consent for this research study
- Non-dependent use of heroin.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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CCT participants
Center-based compulsory treatment (CCT) participants who were placed into compulsory treatment centers for two years for a range of punitive treatment such as education, moral teaching, labor work.
Very basic health care is provided in the CCT centers.
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CCT focuses on behavioral approach, mainly punitive punishment measures.
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MMT participants
Methadone maintenance treatment (MMT) participants who have been receiving MMT treatment.
In Hai Phong City, during the period of this study, voluntary MMT was provided in the community free for people who were assessed as dependent on heroin.
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MMT is a combination of pharmaceutical and behavioral intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heroin abstinence
Time Frame: Preceding 3 months and 30 days
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Free from heroin use (self-reported), confirmed by urine drug screening on interview day.
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Preceding 3 months and 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug-free days
Time Frame: Preceding 3 months and 30 days
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Days without use of any illicit drugs (self-report)
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Preceding 3 months and 30 days
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Drug-use related illegal behaviors
Time Frame: Preceding 3 months and 30 days
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Drug-use related illegal behaviors
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Preceding 3 months and 30 days
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Drug-use related blood-borne virus (BBV) risk behaviors
Time Frame: Preceding 3 months and 30 days
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Drug-use related blood-borne virus (BBV) risk behaviors
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Preceding 3 months and 30 days
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Overdose incidents
Time Frame: Preceding 3 months and 30 days
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Overdose incidents
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Preceding 3 months and 30 days
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Monthly drug spending
Time Frame: Preceding 3 months and 30 days
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Monthly drug spending
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Preceding 3 months and 30 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Alison Ritter, PhD, The University of New South Wales
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC12259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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