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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
Sponsor:
Collaborators:
The Atlantic Philanthropies
FHI 360
Hanoi Medical University
University of Adelaide
Information provided by (Responsible Party):
Alison Ritter, The University of New South Wales

Brief Summary:
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. The design was a combined retrospective and prospective, non-randomized cohort over three years (with data at five time-points). The study was conducted between 2012 and 2015, involving 208 CCT participants and 384 MMT participants with heroin dependence.

Condition or disease Intervention/treatment
Heroin Dependence Other: CCT Other: MMT

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 : Observational
Actual Enrollment : 522 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin
Drug Information available for: Methadone

Group/Cohort Intervention/treatment
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.
Other: CCT
CCT focuses on behavioral approach, mainly punitive punishment measures.

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.
Other: MMT
MMT is a combination of pharmaceutical and behavioral intervention.




Primary Outcome Measures :
  1. Heroin abstinence [ Time Frame: Preceding 3 months and 30 days ]
    Free from heroin use (self-reported), confirmed by urine drug screening on interview day.


Secondary Outcome Measures :
  1. Drug-free days [ Time Frame: Preceding 3 months and 30 days ]
    Days without use of any illicit drugs (self-report)

  2. Drug-use related illegal behaviors [ Time Frame: Preceding 3 months and 30 days ]
    Drug-use related illegal behaviors

  3. 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

  4. Overdose incidents [ Time Frame: Preceding 3 months and 30 days ]
    Overdose incidents

  5. Monthly drug spending [ Time Frame: Preceding 3 months and 30 days ]
    Monthly drug spending



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)

Criteria

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.

Information from the National Library of Medicine

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


Locations
Vietnam
Study site in Vietnam
Hai Phong, Vietnam, 10000
Sponsors and Collaborators
The University of New South Wales
The Atlantic Philanthropies
FHI 360
Hanoi Medical University
University of Adelaide
Investigators
Principal Investigator: Alison Ritter, PhD The University of New South Wales

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alison Ritter, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT03071315     History of Changes
Other Study ID Numbers: HC12259
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alison Ritter, The University of New South Wales:
Economic evaluation
Heroin dependence
Compulsory treatment
Methadone treatment
Vietnam
East and Southeast Asia
Cost-effectiveness

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents