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
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
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
NCT ID
NCT05368675
First Posted
April 26, 2022
Last Updated
May 5, 2022
Sponsor
University of Pennsylvania
Collaborators
National Institute of Drug Abuse, Expertise France
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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