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Methadone Maintenance and HIV Prevention: A Window of Opportunity in China

Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01532609
Acronym
MMT1
Enrollment
220
Registered
2012-02-14
Start date
2009-03-31
Completion date
2011-03-31
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capacity Building, Drug Use, HIV/AIDS

Keywords

Methadone maintenance therapy, Behavioral intervention, Service provider, Drug use

Brief summary

This study is an intervention pilot that integrates the current methadone maintenance treatment (MMT) program in China with psychosocial and behavioral components in order to address the critical link between drug use and HIV/AIDS. The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.

Detailed description

The implementation of the MMT program in China is one of the most significant measures ever taken by the Chinese government to address drug use and HIV prevention challenges. In 2004, China launched a series of MMT programs at eight pilot clinics in five provinces. By December 2007, 503 MMT clinics had been established nationwide across 23 provinces. Several studies have found that positive outcomes in drug use, criminality, and employment were associated with participation in MMT. However, special challenges are facing the current MMT programs are facing: 1) clients' drop-out rates are high; and 2) providers at MMT clinics do not have sufficient training, and some of them hesitate to serve the population. We have recognized the urgent need and conducted the study to address these challenges. The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months. The specific aims of the proposed study are: Specific Aim 1: To assess the feasibility and acceptability of the MMT PLUS intervention with process evaluation and participant feedback. Specific Aim 2: To examine primary outcomes on whether service providers in the intervention group, compared to providers in the standard care, will demonstrate improved adherence to MMT protocol, decrease in prejudicial attitudes, increase in comfort working with MMT clients, increase in motivating clients and making personalized risk management plan. Specific Aim 3: To explore secondary outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report increased motivation to change, improved psychological and physical health, increased positive support network, and reduced HIV risk behavior. Specific Aim 4: To investigate exploratory outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report improved MMT treatment retention and decreased drug use.

Interventions

BEHAVIORALMMT CARE

Intervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions.

Sponsors

Centers for Disease Control and Prevention, China
CollaboratorOTHER_GOV
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Service providers * Age 18 and above * Currently working in MMT clinic * Informed consent MMT clients * Age 18 or over * Currently enrolled in MMT * Informed consent

Exclusion criteria

Service providers * Anyone who does not meet the inclusion criteria. MMT clients: * Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent

Design outcomes

Primary

MeasureTime frame
Service provider's job satisfactionChanges from baseline to 3-, 6- and 9-month follow-up
Service providers' MMT knowledgeChanges from baseline to 3-, 6- and 9-month follow-up
Service provider's prejudical attitude towards drug usersChanges from baseline to 3-, 6- and 9-month follow-up
Provide-client interactionChanges from baseline to 3-, 6- and 9-month follow-up
Provider's perceived stigma due to work with drug using populationChanges from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived risk at workChanges from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived institutional supportChanges from baseline to 3-, 6- and 9-month follow-up

Secondary

MeasureTime frame
Client's drug using behaviorChanges from baseline to 3-, 6- and 9-month follow-up
Client's physical healthChanges from baseline to 3-, 6- and 9-month follow-up
MMT client's mental healthChanges from baseline to 3-, 6- and 9-month follow-up
Client's perceived stigma from MMT clientsChanges from baseline to 3-, 6- and 9-month follow-up
Client's readiness to changeChanges from baseline to 3-, 6- and 9-month follow-up
Client's drug avoidance self-efficacyChanges from baseline to 3-, 6- and 9-month follow-up
Client's social supportChanges from baseline to 3-, 6- and 9-month follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026