Clinical trial NCT03071315: Economic Evaluation Comparing CCT With MMT in Hai Phong City, Vietnam
Official title: Economic Evaluation Comparing Center-based Compulsory Drug Treatment With Community-based Methadone Maintenance Treatment in Hai Phong City, Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heroin Dependence
Keywords: Economic evaluation
Heroin dependence
Compulsory treatment
Methadone treatment
Vietnam
East and Southeast Asia
Cost-effectiveness
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: The Atlantic Philanthropies
name: FHI 360
name: Hanoi Medical University
name: University of Adelaide
First posted: 2017-03-06
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility 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.

Primary outcomes:
measure: Heroin abstinence
timeFrame: Preceding 3 months and 30 days
Secondary outcomes:
measure: Drug-free days
timeFrame: Preceding 3 months and 30 days
measure: Drug-use related illegal behaviors
timeFrame: Preceding 3 months and 30 days
measure: Drug-use related blood-borne virus (BBV) risk behaviors
timeFrame: Preceding 3 months and 30 days
measure: Overdose incidents
timeFrame: Preceding 3 months and 30 days
measure: Monthly drug spending
timeFrame: Preceding 3 months and 30 days
Other outcomes:
Locations:
city: Hai Phong
country: Vietnam
facility: Study site in Vietnam
Study officials:
affiliation: The University of New South Wales
name: Alison Ritter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.