Behavioral Drug and HIV Risk Reduction Counseling With MMT in China
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): Behavioral Drug and HIV Risk Reduction Counseling; Educational Counseling; Treatment as Usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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; 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 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
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment