HIV Risk BehaviorsPhase 2JAKPRONCT01360463
Efficacy of Drug and Risk Counseling Among Methadone Patients in Jakarta, Indonesia
A Phase 2 study testing Behavioral Drug and Risk Counseling (BDRC) and methadone maintenance treatment in people with HIV Risk Behaviors and Heroin Injection, run by University of Pennsylvania at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Risk Behaviors, Heroin Injection, Retention in Methadone Treatment
- What is being tested?
- Behavioral Drug and Risk Counseling (BDRC) and methadone maintenance treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2009to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta
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.
Read more
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.
- Being tested
- Behavioral Drug and Risk Counseling (BDRC), methadone maintenance treatment
- Keywords
- drug abuse counseling, HIV risk reduction counseling, HIV infection, injection drug users, AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Drug and Risk Counseling (BDRC)Behavioural
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 treatmentBehavioural
daily individualized doses of methadone will be provided by the program staff.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral and Drug Risk Counseling | Experimental | Participants assigned to this arm will receive bi weekly Behavioral and Drug Risk Counseling (BDRC) counseling for six months. Receives: Behavioral: Behavioral Drug and Risk Counseling (BDRC) |
| Treatment as Usual | Active comparator | Participants assigned to this arm will receive methadone treatment without and alterations. Receives: Behavioral: methadone maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
retention in methadone treatment
number of months retained in treatment during the one year assessment period.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2009
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Risk BehaviorsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360463
- Sponsor's protocol ID
- JAKPRO
- Other IDs
- R01DA026344
- Acronym
- JAKPRO
- Status last verified
- May 2011
- First submitted
- 23 May 2011
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Drug-HIV Counseling Among IDU at Methadone Clinics in Jakarta
- ClinicalTrials.gov ID
- NCT01360463
- Acronym / sponsor ID
- JAKPRO / JAKPRO
- Keywords
- drug abuse counseling, HIV risk reduction counseling, HIV infection, injection drug users, AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral and Drug Risk Counseling | Experimental | Behavioral: Behavioral Drug and Risk Counseling (BDRC)Participants assigned to this arm will receive bi weekly Behavioral and Drug Risk Counseling (BDRC) counseling for six months. |
| Treatment as Usual | Active comparator | Behavioral: methadone maintenance treatmentParticipants assigned to this arm will receive methadone treatment without and alterations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Behavioral and Drug Risk Counseling |
| methadone maintenance treatmentdaily individualized doses of methadone will be provided by the program staff. | Behavioural | Treatment as Usual |
Primary outcome
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.
1 secondary outcome
retention in methadone treatment
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
Related trials for HIV Risk Behaviors
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
A Chatbot to Reduce Chemsex and HIV-related Risk Behaviors Among Men Who Have Sex With Men
Behavior
Recruiting
Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults
HIV
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavioral Drug and Risk Counseling (BDRC) and methadone maintenance treatment in people with HIV Risk Behaviors and Heroin Injection, run by University of Pennsylvania at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection drug use (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.