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Medication-assisted Treatment for Injecting Drug Users in Vietnam (OIT-HCMC)

Primary Purpose

Opioid Use Disorder, HIV Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
medication for opioid use disorder
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use Disorder focused on measuring medication for opioid use disorder, HIV care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 18 or more years of age

    • Meets DSM-5 criteria for opiate use disorder
    • Positive urine drug screen for heroin or other opiates
    • Interested in methadone maintenance or Suboxone® treatment for opiate use disorder
    • Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks
    • 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

    • Known neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make the patient's participation hazardous
    • Physiologically dependent on alcohol, benzodiazepines, or other sedative type drugs
    • Pending legal charges with likely incarceration within next 12 months

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Retention in treatment program at 12 months
    Percentage of participants who stay in treatment for 12 months
    Adherence in treatment program at 12 months
    Missing doses of treatment during time in the study
    Cost of 12-month treatment program
    Cost of 12 months of the treatment program evaluated with the Drug Abuse Treatment Cost Analysis Program (DATCAP)

    Secondary Outcome Measures

    Change in substance use from baseline to 12-month follow-up
    Evaluation of the change in substance use between baseline and 12-month follow-up assessed by weekly self-report and urine drug screen
    Viral load suppression for people living with HIV
    Percentage of participants living with HIV with a suppressed viral load at 12 months

    Full Information

    First Posted
    April 26, 2022
    Last Updated
    May 5, 2022
    Sponsor
    University of Pennsylvania
    Collaborators
    National Institute of Drug Abuse, Expertise France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05368675
    Brief Title
    Medication-assisted Treatment for Injecting Drug Users in Vietnam
    Acronym
    OIT-HCMC
    Official Title
    A Pilot Implementation Project of Methadone and Suboxone® for Injecting Drug Users in Ho Chi Minh City, Vietnam
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 18, 2013 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    August 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    National Institute of Drug Abuse, Expertise France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    HIV continues to spread around the world and new infections in Asia are one of the most important areas for prevention among drug using populations. There is strong and consistent evidence from several countries that while injection drug users (IDU) continue to be a source of new infections, treatment of opiate addiction is an effective prevention measure against further spread. The project evaluated the implementation of a comprehensive opioid use disorder treatment program co-located with an HIV clinic in Ho Chi Minh City, Vietnam. The program includes medication for opioid use disorder (methadone, buprenorphine/naloxone), standardized counseling sessions (BDRC) and HIV testing and care (for people living with HIV).
    Detailed Description
    The drug treatment and HIV research literature of the past 20 years provides strong support for the ability of drug treatment programs to reduce the frequency of drug use, risk behaviors, and incidence of new infections. Findings from these studies also suggest that drug users living with HIV who remain in medication assisted treatment (MAT) and cease drug use are significantly more likely to achieve sustained viral suppression and consequently less likely to transmit HIV. While these data are strong and consistent, they are all derived from countries with highly developed drug and HIV treatment systems. Little data exist regarding the challenges of implementing and integrating new strategies for MAT with linkages to HIV care in resource-limited settings with developing drug and HIV treatment systems. The proposed project will take place in Ho Chi Minh City (HCMC), Vietnam. In HCMC, 51.8 % of IDUs are estimated to be HIV positive (HCMC Provincial AIDS Committee (PAC) 2009). Methadone maintenance treatment (MMT) for IDUs started as a pilot program in 2008 in Haiphong and HCMC, two of the highest prevalence provinces for injecting drug use. By December 2009, 784 patients were under MMT and 235 were receiving ARV. 30% of patients under MMT are HIV+ (HCMC PAC, 2009). The National goal is to have 80,000 drug users in methadone treatment by 2015. There are currently no buprenorphine/naloxone treatment programs in Vietnam. The proposed project evaluate the implementation of an MAT program (both methadone and buprenorphine/naloxone) integrated within an HIV treatment setting. This is the first project to establish and evaluate the implementation a buprenorphine/naloxone (Suboxone) treatment program in Vietnam. Participants were enrolled in the integrated MAT program that included drug and risk counseling, and for those who are living with HIV, HIV treatment. Participant'received care for 12 months and then transitioned to community treatment program. The study assessed barriers to implementation. Primary measures consisted of facilitators and barriers to implementation and retention in MAT generally and Suboxone treatment specifically. The following specific aims are evaluated: Establish a new integrated MAT treatment program within and HIV treatment setting in HCMC; Evaluate barriers and facilitators to implementation of integrated MAT/HIV treatment; Evaluate patient retention and medication adherence in integrated MAT/HIV Care; Estimate the costs and benefits of MAT treatment strategies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorder, HIV Infections
    Keywords
    medication for opioid use disorder, HIV care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    448 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    medication for opioid use disorder
    Other Intervention Name(s)
    methadone, buprenorphine/naloxone, Behavioral Drug and Risk Counseling
    Intervention Description
    This is an open-label study. The project proposes to enroll up to 500 opiate dependent individuals entering Medication Assisted Treatment (Methadone or buprenorphine/naloxone) at Go Vap Clinic, HCMC, Vietnam. All participants who appear to meet inclusion criteria and who express interest in drug treatment will be invited to be screened for participation in the research. All participants will receive BDRC sessions (weekly for 12 weeks, monthly thereafter until week 52).
    Primary Outcome Measure Information:
    Title
    Retention in treatment program at 12 months
    Description
    Percentage of participants who stay in treatment for 12 months
    Time Frame
    12 months
    Title
    Adherence in treatment program at 12 months
    Description
    Missing doses of treatment during time in the study
    Time Frame
    12 months
    Title
    Cost of 12-month treatment program
    Description
    Cost of 12 months of the treatment program evaluated with the Drug Abuse Treatment Cost Analysis Program (DATCAP)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change in substance use from baseline to 12-month follow-up
    Description
    Evaluation of the change in substance use between baseline and 12-month follow-up assessed by weekly self-report and urine drug screen
    Time Frame
    12 months
    Title
    Viral load suppression for people living with HIV
    Description
    Percentage of participants living with HIV with a suppressed viral load at 12 months
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • 18 or more years of age Meets DSM-5 criteria for opiate use disorder Positive urine drug screen for heroin or other opiates Interested in methadone maintenance or Suboxone® treatment for opiate use disorder Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks 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 Known neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make the patient's participation hazardous Physiologically dependent on alcohol, benzodiazepines, or other sedative type drugs Pending legal charges with likely incarceration within next 12 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles P O'Brien, MD, PhD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Medication-assisted Treatment for Injecting Drug Users in Vietnam

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