Medication-assisted Treatment for Injecting Drug Users in Vietnam

NCT ID: NCT05368675

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-18
• Study Completion Date: 2018-08-31

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.

Conditions

Opioid Use Disorder; HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Interventions

medication for opioid use disorder

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).

Intervention Type: DRUG

Other Intervention Names

methadone; buprenorphine/naloxone; Behavioral Drug and Risk Counseling

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Drug Abuse

FED

Sponsor Role: collaborator

Expertise France

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles P O'Brien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA033671

Identifier Type: NIH

Identifier Source: org_study_id

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