Clinical trial NCT01532609: Methadone Maintenance and HIV Prevention: A Window of Opportunity in China
Official title: Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capacity Building
Drug Use
HIV/AIDS
Keywords: Methadone maintenance therapy
Behavioral intervention
Service provider
Drug use
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2012-02-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Service providers' MMT knowledge
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Service provider's prejudical attitude towards drug users
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Provide-client interaction
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Provider's perceived stigma due to work with drug using population
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Service provider's perceived risk at work
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Service provider's perceived institutional support
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Service provider's job satisfaction
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
Secondary outcomes:
measure: Client's drug using behavior
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Client's physical health
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: MMT client's mental health
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Client's perceived stigma from MMT clients
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Client's readiness to change
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Client's drug avoidance self-efficacy
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
measure: Client's social support
timeFrame: Changes from baseline to 3-, 6- and 9-month follow-up
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: NPI-Center for Community Health, UCLA
name: Li Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.