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

NCT01532609 | Completed DMC

• 1 other identifier: R34MH083512
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Capacity Building; Drug Use; HIV/AIDS

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Service providers' MMT knowledge

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

• Service provider's prejudical attitude towards drug users

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

• Provide-client interaction

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

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

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

• Service provider's perceived risk at work

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

• Service provider's perceived institutional support

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

• Service provider's job satisfaction

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

Secondary Outcomes (7)

• Client's drug using behavior

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

• Client's physical health

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

• MMT client's mental health

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

• Client's perceived stigma from MMT clients

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

• Client's readiness to change

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard care

NO INTERVENTION

No additional training or service is provided for standard care group service providers or clients.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Service providers
• MMT clients:
• Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Centers for Disease Control and Prevention, China: collaborator

Study Sites (1)

Sichuan Provincial Center for Disease Control and Prevention

Chengdu, Sichuan, China

Location

Related Publications (1)

• Li L, Wu Z, Liang LJ, Lin C, Zhang L, Guo S, Rou K, Li J. An intervention targeting service providers and clients for methadone maintenance treatment in China: a cluster-randomized trial. Addiction. 2013 Feb;108(2):356-66. doi: 10.1111/j.1360-0443.2012.04020.x. Epub 2012 Oct 5.

  PMID: 22788780 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Li Li, PhD

  NPI-Center for Community Health, UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 14, 2012
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CN (1)