Clinical trial NCT05368675: Medication-assisted Treatment for Injecting Drug Users in Vietnam
Official title: A Pilot Implementation Project of Methadone and Suboxone® for Injecting Drug Users in Ho Chi Minh City, Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use Disorder
HIV Infections
Keywords: medication for opioid use disorder
HIV care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Drug Abuse
name: Expertise France
First posted: 2022-05-10
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Retention in treatment program at 12 months
timeFrame: 12 months
measure: Adherence in treatment program at 12 months
timeFrame: 12 months
measure: Cost of 12-month treatment program
timeFrame: 12 months
Secondary outcomes:
measure: Change in substance use from baseline to 12-month follow-up
timeFrame: 12 months
measure: Viral load suppression for people living with HIV
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Charles P O'Brien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: