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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01360463

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

276

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2009

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Injection drug use [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

retention in methadone treatment [one year]
number of months retained in treatment during the one year assessment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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