Efficacy of Drug and Risk Counseling Among Methadone Patients in Jakarta, Indonesia (JAKPRO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01360463
First received: May 23, 2011
Last updated: May 24, 2011
Last verified: May 2011

May 23, 2011
May 24, 2011
May 2009
March 2013   (final data collection date for primary outcome measure)
Injection drug use [ Time Frame: one year ] [ Designated as safety issue: No ]
the primary endpoint will be the frequency of injection drug use during the 30 days prior to the final assessment at 12 months.
Same as current
Complete list of historical versions of study NCT01360463 on ClinicalTrials.gov Archive Site
retention in methadone treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
number of months retained in treatment during the one year assessment period.
Same as current
Not Provided
Not Provided
 
Efficacy of Drug and Risk Counseling Among Methadone Patients in Jakarta, Indonesia
Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta

According to UNAIDS, Indonesia is experiencing one of the most rapidly expanding HIV/AIDS epidemics in Asia. The epidemic in Indonesia has been fueled by injection drug use among heroin users and the national response includes the scale-up of methadone maintenance treatment.

Drug counseling is considered to be an integral part of methadone treatment, but few studies have been designed to assess its benefits and costs. In settings such as Jakarta, data regarding the costs and benefits of drug counseling have critical public heath relevance.

The investigators propose to conduct a prospective randomized trial to evaluate the efficacy of integrated drug and HIV counseling among injecting drug users. This study will be conducted at six methadone clinics in Jakarta, Indonesia where the HIV prevalence among injecting drug users ranges between 50- 86%, with collaborators from the Drug Dependence Hospital in Jakarta, the University of Pennsylvania and Yale University. The specific aims of this four year study are to evaluate the impact of Behavioral Drug and Risk Counseling (BDRC)—a low intensity, cognitive behavioral approach that integrates drug counseling and risk reduction intervention. Those assigned to the BDRC arm will be compared to those who receive treatment as usual which includes an initial risk reduction intervention and counseling as needed. The investigators hypothesize that the structured, low intensity BDRC approach will be more cost effective and result in higher rates of retention in treatment, lower rates of drug use and lower rates of HIV risk.

To test these hypotheses, the research team in Jakarta will recruit 300 injecting drug users as they enter treatment at the Drug Dependence Hospital and its five satellite programs. Following informed consent procedures, research staff will randomize participants to either the BDRC intervention or to treatment as usual. All subjects will be fuly assessed at baseline and months 3, 6, 9, and 12.

The proposed work will be build on collaborations that have been established with the Indonesian Investigator Adhi Nurhidayat,MD during his NIDA INVEST Fellowship at University of Pennsylvania when he spent time with David Metzger, PhD and George Woody, MD. It will also extend findings from a WHO study on substitution therapy of opiates and HIV/AIDS that was completed by Riza Sarasvita, MS,MHS (former NIDA Humphrey Fellow at Johns Hopkins University) and her colleagues at The Drug Dependence Hospital Jakarta, Indonesia.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Risk Behaviors
  • Heroin Injection
  • Retention in Methadone Treatment
  • Behavioral: Behavioral Drug and Risk Counseling (BDRC)
    The BDRC counseling is rooted in cognitive behavioral theory. During one hour sessions, the counselors help participant identify short term behavioral goals and work with the participant to develop strategies to achieve their goals. These plans are referred to as "contracts" and these contracts are reviewed and revised at each subsequent session.
  • Behavioral: methadone maintenance treatment
    daily individualized doses of methadone will be provided by the program staff.
  • Experimental: Behavioral and Drug Risk Counseling
    Participants assigned to this arm will receive bi weekly Behavioral and Drug Risk Counseling (BDRC) counseling for six months.
    Intervention: Behavioral: Behavioral Drug and Risk Counseling (BDRC)
  • Active Comparator: Treatment as Usual
    Participants assigned to this arm will receive methadone treatment without and alterations.
    Intervention: Behavioral: methadone maintenance treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment in methadone maintenance treatment
  • Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks
  • 18 or more years of age
  • Meets DSM-IV criteria for opiates dependence with physiologic features
  • Agrees to keep bi-weekly appointments if selected
  • Current address within Jakarta and not planning to move
  • Willingness and ability to give informed consent and otherwise participate
  • Provision of adequate locator information

Exclusion Criteria:

  • Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder
  • Advanced neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make hazardous patient's ability to participate
  • Physiologically dependent on alcohol, benzodiazepines or other sedative type drugs
  • Concurrent participation in another treatment study
  • Planning to enter inpatient or residential treatment within next year
  • Pending legal charges with likely incarceration within next 12 months
Both
18 Years and older
Yes
Contact: Adhi W Nurhidayat, MD, MPH +628158845322 adhinur@yahoo.com
Indonesia
 
NCT01360463
JAKPRO, R01DA026344
No
David S. Metzger, Ph.D. , Principal Investigator, University of Pennsylvania
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Not Provided
University of Pennsylvania
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP