Human Immunodeficiency VirusPhase 4HarapanNCT02396979
Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
A Phase 4 study testing Methadone and Holistic Health Recovery Program in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Yale University.
Trial summary
The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction
- What is being tested?
- Methadone and Holistic Health Recovery Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2014
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected
- Clinical Diagnosis of Opioid Dependence
- Fluent in Bahasa Malaysia or English
- Within 90 to 180 days of release from prison
- Planning to live in Klang Valley region after release from prison
- Able to provide informed consent
Who cannot join
- Pregnancy or planning to become pregnant (female only)
About this study
The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.
- Conditions
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
- Being tested
- Methadone, Holistic Health Recovery Program
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Holistic Health Recovery ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Methadone Maintenance | Experimental | Methadone induction and management provided Receives: Drug: Methadone |
| Holistic Health Recovery Program | Experimental | Administration of the Holistic Health Recovery Program (HHRP-M), which is an eight-session substance abuse relapse prevention and harm reduction program administered by a trained substance abuse counselor. Receives: Behavioral: Holistic Health Recovery Program |
| Methadone Maintenance and Holistic Health Recovery Prorgram | Experimental | Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M). Receives: Drug: Methadone; Behavioral: Holistic Health Recovery Program |
| Standard of Care | No intervention | Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Risk Events
The primary outcome is the number of HIV high risk events. This outcome will be constructed from a composite measure counting the number of unprotected vaginal and anal insertive events and needle-or-syringe-sharing events with an HIV- or HIV-status-unknown partner that might result in HIV transmission to an uninfected partner. As such, the primary outcome will be the number of high-risk events during the period of observation in the intervention. All data will be self-reported by the participant.
Measured: Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12
Secondary outcomes (4)
HIV Quality of Life
This outcome will be measured by a series of questions that will be used to produce a composite score that will indicate the participant's overall quality of life as it relates to their HIV status. These questions will ask about your general health and your ability to perform daily activities in your life. All data will be self-reported by the participant.
Measured: Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12
Relapse to Drug Use
This outcome will be measured as any opioid drug use after release from prison. This outcome will be measured in two ways. First, participants will provide a monthly urine sample that will be tested for the presence of opioids. Second, participants will answer questions about their drug use since the time of their last interview.
Measured: Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12
Addiction Severity
This outcome will be measured by a series of questions about the participant's drug use. These questions will be used to produce a composite score which indicates the severity of the participant's addiction.
Measured: Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12
Reincarceration
This outcome will be measured by both self-report and objective data from the Malaysian Ministry of Prisons. Self-report questions will be used to ask participants if they have been arrested by police (placed in jail) or incarcerated in prison during the time since the last interview. Objective data will also be obtained from the Ministry of Prisons which will indicate if the participant has been reincarcerated in one of Malaysia's prison during the 12 months since they were initially released from prison.
Measured: Any reincarceration to prison during the 12 month post-release follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frederick L Altice, M.D., Principal investigator, Yale UniversityAdeeba Kamarulzaman, M.D., Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396979
- Sponsor's protocol ID
- 0908005646
- Other IDs
- R01DA025943
- Acronym
- Harapan
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2015
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mobley AM, Wegman MP, Bazazi AR, Shenoi SV, Bromberg DJ, Ahmad A, Kamarulzaman A, Altice FL. Prescribing methadone in prison predicts linkage to HIV care after release from prison: A randomized and patient preference trial. Int J Drug Policy. 2025 Mar;137:104733. doi: 10.1016/j.drugpo.2025.104733. Epub 2025 Feb 8.
PubMed 39923270Bazazi AR, Culbert GJ, Wegman MP, Heimer R, Kamarulzaman A, Altice FL. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.
PubMed 36368939Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ. Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia. HIV Res Clin Pract. 2019 Feb;20(1):12-23. doi: 10.1080/15284336.2019.1603433. Epub 2019 May 1.
PubMed 31303149
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
- ClinicalTrials.gov ID
- NCT02396979
- Acronym / sponsor ID
- Harapan / 0908005646
- Conditions
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Malaya, National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Mar 2015 (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.
The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methadone Maintenance | Experimental | Drug: MethadoneMethadone induction and management provided |
| Holistic Health Recovery Program | Experimental | Behavioral: Holistic Health Recovery ProgramAdministration of the Holistic Health Recovery Program (HHRP-M), which is an eight-session substance abuse relapse prevention and harm reduction program administered by a trained substance abuse counselor. |
| Methadone Maintenance and Holistic Health Recovery Prorgram | Experimental | Drug: Methadone, Behavioral: Holistic Health Recovery ProgramMethadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M). |
| Standard of Care | No intervention | –Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-infected
- Clinical Diagnosis of Opioid Dependence
- Fluent in Bahasa Malaysia or English
- Within 90 to 180 days of release from prison
- Planning to live in Klang Valley region after release from prison
Key exclusion criteria (1 listed)
- Pregnancy or planning to become pregnant (female only)
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 |
|---|---|---|
| Methadone | Drug | Methadone Maintenance, Methadone Maintenance and Holistic Health Recovery Prorgram |
| Holistic Health Recovery Program | Behavioural | Holistic Health Recovery Program, Methadone Maintenance and Holistic Health Recovery Prorgram |
Primary outcome
HIV Risk Events
Time frame: Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12
The primary outcome is the number of HIV high risk events. This outcome will be constructed from a composite measure counting the number of unprotected vaginal and anal insertive events and needle-or-syringe-sharing events with an HIV- or HIV-status-unknown partner that might result in HIV transmission to an uninfected partner. As such, the primary outcome will be the number of high-risk events during the period of observation in the intervention. All data will be self-reported by the participant.
4 secondary outcomes
HIV Quality of Life
Time frame: Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12
Relapse to Drug Use
Time frame: Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12
Addiction Severity
Time frame: Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12
Reincarceration
Time frame: Any reincarceration to prison during the 12 month post-release follow-up period
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 26 Feb 2024.
- Derived from this study: PubMed 39923270Mobley AM, Wegman MP, Bazazi AR, Shenoi SV, Bromberg DJ, Ahmad A, Kamarulzaman A, Altice FL. Prescribing methadone in prison predicts linkage to HIV care after release from prison: A randomized and patient preference trial. Int J Drug Policy. 2025 Mar;137:104733. doi: 10.1016/j.drugpo.2025.104733. Epub 2025 Feb 8.
- Derived from this study: PubMed 36368939Bazazi AR, Culbert GJ, Wegman MP, Heimer R, Kamarulzaman A, Altice FL. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.
- Derived from this study: PubMed 31303149Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ. Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia. HIV Res Clin Pract. 2019 Feb;20(1):12-23. doi: 10.1080/15284336.2019.1603433. Epub 2019 May 1.
- Individual participant dataSharing planned: Undecided
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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.
Frederick L Altice, M.D. principal investigator
Yale University
Adeeba Kamarulzaman, M.D. principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone and Holistic Health Recovery Program in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Yale University.
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 6 inclusion and 1 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HIV Risk Events (time frame: Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396979, which also lists 3 linked publications.
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 26 Feb 2024.