Economic Evaluation Comparing CCT With MMT in Hai Phong City, Vietnam
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|ClinicalTrials.gov Identifier: NCT03071315|
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment|
|Heroin Dependence||Other: CCT Other: MMT|
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 :||Observational|
|Actual Enrollment :||522 participants|
|Official Title:||Economic Evaluation Comparing Center-based Compulsory Drug Treatment With Community-based Methadone Maintenance Treatment in Hai Phong City, Vietnam|
|Actual Study Start Date :||January 20, 2013|
|Actual Primary Completion Date :||January 30, 2015|
|Actual Study Completion Date :||January 30, 2015|
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.
CCT focuses on behavioral approach, mainly punitive punishment measures.
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.
MMT is a combination of pharmaceutical and behavioral intervention.
- Heroin abstinence [ Time Frame: Preceding 3 months and 30 days ]Free from heroin use (self-reported), confirmed by urine drug screening on interview day.
- Drug-free days [ Time Frame: Preceding 3 months and 30 days ]Days without use of any illicit drugs (self-report)
- Drug-use related illegal behaviors [ Time Frame: Preceding 3 months and 30 days ]Drug-use related illegal behaviors
- Drug-use related blood-borne virus (BBV) risk behaviors [ Time Frame: Preceding 3 months and 30 days ]Drug-use related blood-borne virus (BBV) risk behaviors
- Overdose incidents [ Time Frame: Preceding 3 months and 30 days ]Overdose incidents
- Monthly drug spending [ Time Frame: Preceding 3 months and 30 days ]Monthly drug spending
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): NCT03071315
|Study site in Vietnam|
|Hai Phong, Vietnam, 10000|
|Principal Investigator:||Alison Ritter, PhD||The University of New South Wales|