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Completed

NCT Number: NCT01360463

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Drug and Risk Counseling (BDRC)

Behavioral

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.

methadone maintenance treatment

Behavioral

daily individualized doses of methadone will be provided by the program staff.

Primary outcomes

  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 outcomes

  1. retention in methadone treatment

    Time frame: one year

    number of months retained in treatment during the one year assessment period.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta

Acronym: JAKPRO

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 25, 2011
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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