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Completed

NCT Number: NCT01532609

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

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.

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Key information

Conditions

Capacity Building Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Drug Use Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Provincial Center for Disease Control and Prevention

Chengdu, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMT CARE

Behavioral

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.

Primary outcomes

  1. Service providers' MMT knowledge

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  2. Service provider's prejudical attitude towards drug users

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  3. Provide-client interaction

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  4. Provider's perceived stigma due to work with drug using population

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  5. Service provider's perceived risk at work

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  6. Service provider's perceived institutional support

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  7. Service provider's job satisfaction

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

Secondary outcomes

  1. Client's drug using behavior

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  2. Client's physical health

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  3. MMT client's mental health

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  4. Client's perceived stigma from MMT clients

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  5. Client's readiness to change

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  6. Client's drug avoidance self-efficacy

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

  7. Client's social support

    Time frame: Changes from baseline to 3-, 6- and 9-month follow-up

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Centers for Disease Control and Prevention, China

Registry information

Official study title

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

Acronym: MMT1

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 14, 2012
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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