An interventional study of MMT CARE in Capacity Building, Drug Use and HIV/AIDS, sponsored by University of California, Los Angeles. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 220 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Service providers
MMT clients
Exclusion Criteria:
Service providers
MMT clients:
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.
Behavioral: MMT CARE
No additional training or service is provided for standard care group service providers or clients.
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.
Service providers' MMT knowledge
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's prejudical attitude towards drug users
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Provide-client interaction
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Provider's perceived stigma due to work with drug using population
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived risk at work
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived institutional support
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's job satisfaction
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's drug using behavior
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's physical health
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
MMT client's mental health
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's perceived stigma from MMT clients
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's readiness to change
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's drug avoidance self-efficacy
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's social support
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
The record gives a start of Mar 2009, a primary completion of Dec 2010 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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