Clinical trial NCT01389180: Behavioral Drug and HIV Risk Reduction Counseling With MMT in China
Official title: Behavioral Drug and HIV Risk Reduction Counseling With MMT in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opiate Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Reduction of drug- and sex-related HIV risk behaviors
timeFrame: Up to 10 months
measure: Reduction of frequency (days of illicit opiate use in each month) of heroin or other illicit opiate use
timeFrame: Up to 10 months
Secondary outcomes:
measure: Treatment retention
timeFrame: at 16 weeks
measure: Reductions in other illicit drug use
timeFrame: Up to 10 months
measure: Improvements of functional status (e.g., in vocational, family, and social functioning, and healthcare and other resource utilization)
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Center for Disease Control & Prevention
state: Hubei
Study officials:
affiliation: Center for Disease Control & Prevention, China
name: Wang Zhou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: