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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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360463

Contacts
Contact: Adhi W Nurhidayat, MD, MPH +628158845322 adhinur@yahoo.com

Locations
Indonesia
RSKO Drug Dependence Hospital Recruiting
Jakarta, Timur, Indonesia, 13720
Contact: Eva Susami, MPH       e_susami@yahoo.com   
Principal Investigator: Adhi W Nurhidayat, MD.MPH         
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: David S. Metzger, Ph.D. , Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01360463     History of Changes
Other Study ID Numbers: JAKPRO, R01DA026344
Study First Received: May 23, 2011
Last Updated: May 24, 2011
Health Authority: United States: National Institute on Drug Abuse
Indonesia: Ministry of Health

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

Additional relevant MeSH terms:
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014