Behavioral Drug and HIV Risk Reduction Counseling With MMT in China

This study is currently recruiting participants.
Verified January 2014 by Yale University
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by (Responsible Party):
Marek Cezary Chawarski, Yale University
ClinicalTrials.gov Identifier:
NCT01389180
First received: May 11, 2011
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

This study will provide critical data regarding the efficacy for reducing drug-and sex-related HIV transmission risk behaviors, as well as improving methadone maintenance treatment (MMT) outcomes and patient functioning of two transportable counseling models, behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as compared with the current standard of care model in MMT in China. Evidence-based counseling that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT will greatly improve the public health benefits of disseminating MMT in China and elsewhere in the world.


Condition Intervention Phase
Opiate Dependence
Behavioral: Behavioral Drug and HIV Risk Reduction Counseling
Behavioral: Educational Counseling
Behavioral: Treatment as Usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Drug and HIV Risk Reduction Counseling With MMT in China

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction of drug- and sex-related HIV risk behaviors [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
    drug-related and sex-related HIV risk behaviors will be assessed by audio computer-assisted self-interview

  • Reduction of frequency (days of illicit opiate use in each month) of heroin or other illicit opiate use [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
    days of illicit opiate use in each month will be based on self report and urine toxicology tests


Secondary Outcome Measures:
  • Treatment retention [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
    Treatment retention is defined as time in treatment from the treatment entry to treatment completion or discontinuation

  • Reductions in other illicit drug use [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
    Reductions in other illicit drug use are based on self-report and urine toxicology screens

  • Improvements of functional status (e.g., in vocational, family, and social functioning, and healthcare and other resource utilization) [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
    Improvements of functional status are based on the results of Addiction Severity Index assessment instrument


Estimated Enrollment: 300
Study Start Date: December 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDRC Behavioral: Behavioral Drug and HIV Risk Reduction Counseling
BDRC is a highly individualized, structured, and prescriptive behavioral treatment designed to be provided by nursing or other available personnel in China who generally do not have advanced training or experience in psychotherapy or counseling techniques. BDRC provides education about HIV, Hepatitis C, and other bloodborne or infectious diseases, heroin addiction and MMT, incorporates coping skills training components of CBT, and makes use of explicit and detailed short-term behavioral contracts (either verbal or written), aimed at small, easily achievable, and measurable objectives linked to reduction of HIV risk behaviors and heroin use and improvements in daily functioning supporting sustained recovery
Experimental: EC Behavioral: Educational Counseling
EC uses a didactic lecture-discussion format, incorporating charts, slides, and audiovisual materials and handouts, to educate the patient about core recovery topics, including HIV and other infectious diseases transmission and effective protection strategies, heroin addiction and treatment with methadone maintenance, the importance of taking the methadone regularly, staying away from drugs, and improving social, family and vocational functioning.
TAU Behavioral: Treatment as Usual
TAU group will receive manual-guided minimal counseling approximating the current standard of care provided in MMTs in China, consisting of an initial introductory session (introduction to MMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month

Detailed Description:

China currently has 1.2 to 3.5 million heroin users (50% with current injection drug use, IDU), and more than 650,000 HIV infected individuals, with 75,000 new infections each year and the majority of HIV infections attributable to IDU. The Chinese government recently embarked on an ambitious program to make methadone maintenance treatment (MMT) widely available to all heroin addicts. By the end of 2008, approximately 560 methadone maintenance treatment clinics had been established, providing treatment to an estimated 166,000 heroin users. However, the current methadone programs provide limited or no drug counseling, and, despite considerable initial promise, many patients continue drug use and risky behaviors while still in MMT or discontinue treatment prematurely. In addition to risky injecting practices, drug users in China also commonly engage in risky sexual practices. Most of China's drug users are young, unmarried, sexually active and only a small fraction report consistent condom use. Their knowledge about HIV/AIDS, sexually transmitted diseases and blood borne viruses is very poor. The combination of poor knowledge and frequent engagement in high-risk behaviors increases their own risk of infections, and also contributes significantly to the spread of HIV into the general population. [Consequently, we propose a randomized clinical trial to compare the efficacy of MMT combined with one of three manual-guided counseling approaches, Behavioral Drug and HIV Risk Reduction Counseling (BDRC), Educational Counseling (EC), and counseling approximating what is provided as treatment as usual (TAU) in China. Efficacy will be evaluated with regard to our primary outcome measures: reduction of drug- and sex-related HIV risk behaviors, reduction of frequency of heroin or other illicit opiate use, and duration of opiate abstinence. The study will also evaluate treatment effects on secondary outcome measures (including treatment retention, reductions in other illicit drug use, and improvements of functional status of MMT patients) and incremental resource utilization associated with BDRC, EC and TAU. In preliminary work, we have developed and pilot tested Mandarin versions of the BDRC manual, BDRC and EC training materials, and assessment instruments. Treatment seeking volunteers(N=300) entering MMT will be randomly assigned to 4 months of treatment with one of the three manual-guided treatments. A standard methadone induction and dosing protocol will be used for all subjects to ensure comparable methadone dosages in all groups. All primary and secondary outcome measures will be evaluated during the 4 months of MMT treatment phase and for 6 months following the active treatment phase.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treatment seeking volunteers meeting DSM-IV criteria for opiate dependence, as assessed by SCID interview and documented by opioid positive urine toxicology testing, entering MMT in Wuhan. China

Exclusion Criteria:

  • current dependence on alcohol, benzodiazepines or sedatives
  • current suicide or homicide risk
  • current psychotic disorder or major depression
  • inability to understand the protocol or assessment questions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389180

Contacts
Contact: Wang Zhou, M.D., Ph.D. 86-27-5951-2796 rising-up@hotmail.com

Locations
China, Hubei
Center for Disease Control & Prevention Recruiting
Wuhan, Hubei, China
Principal Investigator: Wang Zhou, M.D., Ph.D.         
Sponsors and Collaborators
Yale University
Centers for Disease Control and Prevention, China
Investigators
Principal Investigator: Wang Zhou, M.D., Ph.D. Center for Disease Control & Prevention, China
  More Information

No publications provided

Responsible Party: Marek Cezary Chawarski, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01389180     History of Changes
Other Study ID Numbers: 0907005504
Study First Received: May 11, 2011
Last Updated: January 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014