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Trial record 19 of 21 for:    "Bacterial Infectious Disease" | "Guaifenesin"

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings (HARAPAN II)

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ClinicalTrials.gov Identifier: NCT03089983
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
University of Malaya
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to conduct empiric studies of tuberculosis (TB) among prison inmates with a history of opioid dependence. This includes: a) comprehensive TB diagnostic study (symptom screening, chest x-ray, tuberculin skin test, acid-fast bacilli smear, Gene Xpert, and sputum culture) to determine best practices for screening HIV+ and HIV- prisoners; b) A RCT of latent TB infection prevention strategies among HIV+ and HIV- prisoners with high prevalence of hepatitis C (HCV) using standard 40-week daily isoniazid (40H) vs short-course weekly isoniazid + rifapentine (12HR); and c) a 3-arm preference trial comparing post-release TB treatment completion in patients on opioid agonist treatment (methadone vs naltrexone implant) vs no opioid agonist treatment in patients being treated for active or latent TB who are transitioning to the community. Investigators will also use this data, and publicly available data to complete agent-based modeling for comparative and cost-effectiveness of various TB screening and treatment strategies among prisoners, and upon community transition post-release from prison.

Condition or disease Intervention/treatment Phase
Opioid Dependence Addiction HIV/AIDS Tuberculosis Hepatitis Drug: Naltrexone Drug: Methadone Drug: Isoniazid Drug: Rifapentine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No medication-assisted treatment (control group)
The control group will choose to receive no opioid agonist treatment upon release from prison.
Drug: Isoniazid
Participants will be randomized to receive standard INH as TB treatment in prison for 26 weeks.

Active Comparator: Methadone maintenance treatment (MMT)
Methadone maintenance treatment (MMT) is the standard of care in Malaysia, and participants who choose this arm will receive MMT upon release from prison.
Drug: Methadone
Participants will receive daily or weekly doses of oral methadone.

Drug: Isoniazid
Participants will be randomized to receive standard INH as TB treatment in prison for 26 weeks.

Experimental: Naltrexone (NTX)
Participants who choose naltrexone (NTX) will receive an NTX implant that lasts for 90 days upon release from prison.
Drug: Naltrexone
A naltrexone implant lasting 90 days will be used to deliver naltrexone.

Drug: Isoniazid
Participants will be randomized to receive standard INH as TB treatment in prison for 26 weeks.

Active Comparator: Standard Isoniazid (INH) for 26 weeks
Participants will be randomized to receive INH, the standard of care in Malaysia, for 26 weeks while in prison.
Drug: Isoniazid
Participants will be randomized to receive standard INH as TB treatment in prison for 26 weeks.

Experimental: Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks
Participants will be randomized to receive INH + RIF as TB treatment while in prison.
Drug: Isoniazid
Participants will be randomized to receive standard INH as TB treatment in prison for 26 weeks.

Drug: Rifapentine
Participants will be randomized to receive short course INH + RIF as TB treatment in prison for 12 weeks.




Primary Outcome Measures :
  1. TB treatment completion rates in prison using a visual analog scale (VAS) [ Time Frame: 6 months ]
    TB treatment adherence in prison will be measured monthly using a visual analog scale, and will be verified using medical records. All TB treatment in prison will be administered under directly observed therapy (DOTs), and treatment administration will be recorded in the participant's prison medical record.

  2. TB treatment completion rates after release from prison using a visual analog scale (VAS) [ Time Frame: 6 months ]
    Investigators will use a visual analog scale to collect monthly self-reported data (which will be verified with pill count data) on TB medication adherence to determine if implantable NTX or MMT will improve the likelihood that participants will complete their TB treatment within 6 months after release from prison.


Secondary Outcome Measures :
  1. Self-reported opioid agonist treatment (MMT or NTX) adherence using a visual analog scale (VAS) [ Time Frame: monthly for 6 months ]
    Investigators will use a visual analog scale to collect monthly self-reported data (which will be verified with pharmacy data) of MMT or NTX adherence monthly.

  2. Self-reported ART adherence (for HIV+ participants) using a visual analog scale (VAS) [ Time Frame: monthly for 6 months ]
    Investigators will use a visual analog scale to collect monthly self-reported data of ART adherence in participants that are HIV-positive.

  3. Percentage of opioid negative urine tests [ Time Frame: monthly for 6 months ]
    Monthly rapid urine drug screens will be used to measure drug use.

  4. Time to opioid relapse using urine drug tests [ Time Frame: monthly for 6 months ]
    Monthly rapid urine drug screens will be used to detect opioid use.

  5. Drug craving using a craving scale [ Time Frame: monthly for 6 months ]
    A substance use craving scale will be used to measure drug craving in the past month.

  6. Addiction severity, employment, legal, and social functioning using the ASI-Lite [ Time Frame: every 3 months, for up to 6 months ]
    Addiction severity, employment, legal issues and social functioning will be measured using the short ASI-Lite questionnaire on the day of enrollment, and every 3 months for up to 6 months.

  7. Health-related quality of life using the SF-12v2 [ Time Frame: every 3 months, for up to 6 months ]
    Health-related quality of life will be measured on the day of enrollment, and every 3 months for up to 6 months.questionnaire.

  8. Overdose or death reported from members of social network [ Time Frame: monthly for 6 months ]
    Participants will be asked to identify up to five family members or friends that they are in regular contact with. If investigators cannot get a hold of the participants for monthly follow-up interviews, then members of their social network will be contacted and asked about overdose or death. Additionally, participants will be asked if they experienced an overdose in the previous month at their monthly interviews.

  9. Re-incarceration reports from Ministry of Justice and self-reported arrests [ Time Frame: monthly for 6 months ]
    If investigators cannot get a hold of the participants for monthly follow-up interviews, Ministry of Justice and Department of Prisons records will be reviewed for re-incarceration records. Additionally, participants will complete a questionnaire every 3 months to assess whether they were placed in police lock-up or arrested recently.

  10. Self-reported patient satisfaction using a questionnaire [ Time Frame: every 3 months, for up to 6 months ]
    Participants will be asked to rate their satisfaction of MMT or NTX on the day of enrollment, and every 3 months for up to 6 months.


Other Outcome Measures:
  1. TB treatment tolerability/toxicity measured through liver function tests (AST/ALT levels) [ Time Frame: monthly for up to 6 months ]
    All participants will have their AST/ALT levels (rapid test using a blood sample) checked monthly for abnormal laboratory values (>5 upper limit normal) that may result in adverse events that may be related to TB treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria (part A):

  • Age ≥ 18 years
  • Newly admitted inmate at Kajang Prison

Inclusion Criteria (part B):

  • Age ≥ 18 years HIV-1 seropositivity
  • Confirmed LTBI (TST ≥ 5mm if HIV+; TST ≥ 10 mm if HIV-)
  • Meets DSM-V criteria for opioid dependence
  • >9 months before release (to ensure treatment completion in prison)
  • AST/ALT < 3x upper limit normal

Inclusion Criteria (part C):

  • Age ≥ 18 years
  • Confirmed active (chest X-ray or laboratory) or LTBI (TST ≥ 5mm if HIV+; TST ≥ 10 mm if HIV-)
  • Meets DSM-V criteria for opioid dependence
  • < 3 months before release, but more > 3 months of TB treatment remaining.
  • Living with in the Klang Valley after release (within 25 km of community research site)
  • AST/ALT <5x upper limit normal
  • Malaysian citizen (non-Malaysians not eligible for receiving standard of care)

Exclusion Criteria:

  • Unable to provide informed consent
  • On a protease inhibitor
  • Women who are pregnant or are planning on becoming pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089983


Contacts
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Contact: Frederick Altice, MD (203) 737-2883 frederick.altice@yale.edu
Contact: Ruthanne Marcus (203) 764-9958 ruthanne.marcus@yale.edu

Locations
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Malaysia
Kajang Prison Recruiting
Kajang, Selangor, Malaysia
Contact: Adeeba Kamarulzaman, MBBS         
Principal Investigator: Adeeba Kamarulzaman, MBBS         
Sponsors and Collaborators
Yale University
University of Malaya
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Frederick Altice, MD Yale University
Principal Investigator: Adeeba Kamarulzaman, MBBS University of Malaya

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03089983     History of Changes
Other Study ID Numbers: 2000020053
1R01DA041271 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yale University:
prison

Additional relevant MeSH terms:
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Gram-Positive Bacterial Infections
Bacterial Infections
Antitussive Agents
Tuberculosis
Behavior, Addictive
Opioid-Related Disorders
Mycobacterium Infections
Actinomycetales Infections
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Methadone
Isoniazid
Rifapentine
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Respiratory System Agents
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents