Efficacy of Drug and Risk Counseling Among Methadone Patients in Jakarta, Indonesia
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Risk Behaviors; Heroin Injection; Retention in Methadone Treatment
Intervention: Behavioral Drug and Risk Counseling (BDRC) (Behavioral); methadone maintenance treatment (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Pennsylvania Overall contact:
Adhi W Nurhidayat, MD, MPH, Phone: +628158845322, Email: adhinur@yahoo.com
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.
Clinical Details
Official title: Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Injection drug use
Secondary outcome: retention in methadone treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Adhi W Nurhidayat, MD, MPH, Phone: +628158845322, Email: adhinur@yahoo.com
RSKO Drug Dependence Hospital, Jakarta, Timur 13720, Indonesia; Recruiting
Eva Susami, MPH, Email: e_susami@yahoo.com
Adhi W Nurhidayat, MD.MPH, Principal Investigator
Additional Information
Starting date: May 2009
Last updated: May 24, 2011
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