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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360463
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : August 17, 2016
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Pennsylvania

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Risk Behaviors Heroin Injection Retention in Methadone Treatment Behavioral: Behavioral Drug and Risk Counseling (BDRC) Behavioral: methadone maintenance treatment Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta
Study Start Date : May 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.

Active Comparator: Treatment as Usual
Participants assigned to this arm will receive methadone treatment without and alterations.
Behavioral: methadone maintenance treatment
daily individualized doses of methadone will be provided by the program staff.

Primary Outcome Measures :
  1. Injection drug use [ Time Frame: one year ]
    the primary endpoint will be the frequency of injection drug use during the 30 days prior to the final assessment at 12 months.

Secondary Outcome Measures :
  1. retention in methadone treatment [ Time Frame: one year ]
    number of months retained in treatment during the one year assessment period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360463

RSKO Drug Dependence Hospital
Jakarta, Timur, Indonesia, 13720
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)

Responsible Party: David S. Metzger, Ph.D. , Principal Investigator, University of Pennsylvania Identifier: NCT01360463     History of Changes
Other Study ID Numbers: JAKPRO
R01DA026344 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: May 2011

Keywords provided by University of Pennsylvania:
drug abuse counseling
HIV risk reduction counseling
HIV infection
injection drug users

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents