Economic Evaluation Comparing CCT With MMT in Hai Phong City, Vietnam

NCT ID: NCT03071315

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

522 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-20

Study Completion Date

2015-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heroin Dependence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CCT

Intervention Type OTHER

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.

MMT

Intervention Type OTHER

MMT is a combination of pharmaceutical and behavioral intervention.

Interventions

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CCT

CCT focuses on behavioral approach, mainly punitive punishment measures.

Intervention Type OTHER

MMT

MMT is a combination of pharmaceutical and behavioral intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* Younger than 18 years old
* Severe cognitive or mental impairment
* Unable to grant consent for this research study
* Non-dependent use of heroin.


* Younger than 18 years old
* Severe cognitive or mental impairment
* Unable to grant consent for this research study
* Non-dependent use of heroin.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Atlantic Philanthropies

OTHER

Sponsor Role collaborator

FHI 360

OTHER

Sponsor Role collaborator

Hanoi Medical University

OTHER

Sponsor Role collaborator

University of Adelaide

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Alison Ritter

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Ritter, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of New South Wales

Locations

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Study site in Vietnam

Haiphong, Hai Phong, Vietnam

Site Status

Countries

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Vietnam

References

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Vuong T, Ritter A, Shanahan M, Ali R, Nguyen N, Pham K, Vuong TTA, Le GM. Outcomes of compulsory detention compared to community-based voluntary methadone maintenance treatment in Vietnam. J Subst Abuse Treat. 2018 Apr;87:9-15. doi: 10.1016/j.jsat.2018.01.011. Epub 2018 Jan 16.

Reference Type DERIVED
PMID: 29471930 (View on PubMed)

Other Identifiers

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HC12259

Identifier Type: -

Identifier Source: org_study_id

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