Behavioral Drug and HIV Risk Reduction Counseling With MMT in China

NCT01389180 | Completed Phase 3

• 2 other identifiers: 0907005504R01DA026797-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Dependence

Outcome Measures

Primary Outcomes (2)

• Reduction of drug- and sex-related HIV risk behaviors

  drug-related and sex-related HIV risk behaviors will be assessed by audio computer-assisted self-interview

  Up to 10 months

• Reduction of frequency (days of illicit opiate use in each month) of heroin or other illicit opiate use

  days of illicit opiate use in each month will be based on self report and urine toxicology tests

  Up to 10 months

Secondary Outcomes (3)

• Treatment retention

  at 16 weeks

• Reductions in other illicit drug use

  Up to 10 months

• Improvements of functional status (e.g., in vocational, family, and social functioning, and healthcare and other resource utilization)

  Up to 10 months

Study Arms (3)

BDRC

EXPERIMENTAL

Behavioral: Behavioral Drug and HIV Risk Reduction Counseling

EC

EXPERIMENTAL

Behavioral: Educational Counseling

TAU

OTHER

Behavioral: Treatment as Usual

Interventions

Behavioral Drug and HIV Risk Reduction Counseling BEHAVIORAL

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

BDRC

Educational Counseling BEHAVIORAL

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.

EC

Treatment as Usual BEHAVIORAL

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

TAU

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Centers for Disease Control and Prevention, China: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Disease Control & Prevention

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Wang Zhou, M.D., Ph.D.

  Center for Disease Control & Prevention, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: July 7, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

CN (1)