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

HIV Risk Behaviors Clinical Trial

— JAKPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360463
• Other study ID #: JAKPRO
• Secondary ID: R01DA026344
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2011
• Last updated: August 15, 2016
• Start date: May 2009
• Est. completion date: January 2015

Study information

• Verified date: May 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institute on Drug AbuseIndonesia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Injection
• HIV Risk Behaviors
• Retention in Methadone Treatment

Intervention

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

Locations

Country	Name	City	State
Indonesia	RSKO Drug Dependence Hospital	Jakarta	Timur

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection drug use	the primary endpoint will be the frequency of injection drug use during the 30 days prior to the final assessment at 12 months.	one year	No
Secondary	retention in methadone treatment	number of months retained in treatment during the one year assessment period.	one year	No