Clinical trial NCT04798534: Intervention to Facilitate MMT/HIV Service Decentralization in Vietnam
Official title: Facilitating the Decentralization of Methadone Maintenance Therapy Services Into Communities in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Vietnam
Service Decentralization
Methadone maintenance therapy
HIV
Community health setting
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Hygiene and Epidemiology, Vietnam
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Vietnam is currently decentralizing its methadone maintenance therapy (MMT) dispensing network to its local commune health centers (CHC), which provides a window of opportunity to study decentralization of harm reduction and HIV-related healthcare services into community-based healthcare settings. Commune health workers (CHW) in Vietnam have widespread misconceptions about harm reduction and perceived significant challenges associated with treating people who use drugs. Intervention effort is needed to address these issues to ensure a smooth implementation of the decentralized service model. This study is to pilot testing an intervention with a primary focus on process optimization in six CHC-based MMT distribution sites with 30 CHW and 90 MMT patients. The six CHC in Thai Nguyen Province of Vietnam will be randomized to either an intervention condition or a control condition. The intervention will be executed through a combination of in-person training and mobile phone application utilization. The intervention outcomes on CHW and MMT clients will be evaluated at baseline, 3-, and 6-months.

Detailed description: The intervention pilot will be conducted in six commune health center (CHC)-based methadone maintenance therapy (MMT) distribution sites in Thai Nguyen Province of Vietnam. Five commune health workers (CHW) and 15 MMT clients will be recruited from each of the CHC (total n = 30 CHW and 90 MMT clients). The six CHC will be matched into pairs based on the current number of CHW and MMT patient load; and within each pair, the two CHC will be randomized into either a control condition or an intervention condition. The intervention contents will include the promotion of streamlined procedure, skill training, problem solving, knowledge acquisition, networking and support, and information sharing. The intervention will be delivered through a combination of service provider in-person training and mobile phone application utilization. Provider-level outcomes (e.g., CHW's MMT/HIV service provision) and client-level outcomes (e.g., treatment progress) will be measured at baseline, 3-, and 6-month follow-ups.

Eligibility criteria: MMT patients (n=90):

Inclusion criteria:

* Age 18 or over
* Currently seeking MMT services in one of the participating commune health centers
* Voluntary informed consent

Exclusion criteria:

* Having psychosis or neurological damage, or cannot understand the study purposes as judged by the recruiter in consultation with a clinic supervisor.
* Inability to give informed consent

CHW (n=30):

Inclusion criteria:

* Age 18 or over
* Currently working in one of the participating commune health centers and have direct contact with MMT clients
* Providing informed consent

Exclusion criteria:

• Inability to provide informed consent

Primary outcomes:
measure: CHW's service provision for MMT providers
timeFrame: From baseline to 3-month
measure: CHW's service provision for MMT providers
timeFrame: From baseline to 6-month
measure: Patients' adherence to MMT
timeFrame: From baseline to 3-month
measure: Patients' adherence to MMT
timeFrame: From baseline to 6-month
Secondary outcomes:
measure: Patients' level of satisfaction with community-based services
timeFrame: From baseline to 3-month
measure: Patients' level of satisfaction with community-based services
timeFrame: From baseline to 6-month
measure: Patients' service preference
timeFrame: From baseline to 3-month
measure: Patients' service preference
timeFrame: From baseline to 6-month
measure: Patients' addiction and HIV-related service utilization
timeFrame: From baseline to 3-month
measure: Patients' addiction and HIV-related service utilization
timeFrame: From baseline to 6-month
measure: CHW's level of adherence to the working procedure
timeFrame: From baseline to 3-month
measure: CHW's level of adherence to the working procedure
timeFrame: From baseline to 6-month
measure: CHW's knowledge in harm reduction and HIV/AIDS will be assessed using a set of true-or-false questions based on the previously developed assessments
timeFrame: From baseline to 3-month
measure: CHW's knowledge in harm reduction and HIV/AIDS will be assessed using a set of true-or-false questions based on the previously developed assessments
timeFrame: From baseline to 6-month
measure: CHW's perceived challenges and administrative burdens in treating MMT patients
timeFrame: From baseline to 3-month
measure: CHW's perceived challenges and administrative burdens in treating MMT patients
timeFrame: From baseline to 6-month
measure: CHW's job satisfaction
timeFrame: From baseline to 3-month
measure: CHW's job satisfaction
timeFrame: From baseline to 6-month
measure: CHW's stigma associated with substance use
timeFrame: From baseline to 3-month
measure: CHW's stigma associated with substance use
timeFrame: From baseline to 6-month
measure: CHW's stigma associated with HIV
timeFrame: From baseline to 3-month
measure: CHW's stigma associated with HIV
timeFrame: From baseline to 6-month
Other outcomes:
measure: MMT patients' mental health
timeFrame: From baseline to 3-month
measure: MMT patients' mental health
timeFrame: From baseline to 6-month
measure: MMT patients' heroin use
timeFrame: From baseline to 3-month
measure: MMT patients' heroin use
timeFrame: From baseline to 6-month
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Hygiene and Epidemiology
Study officials:
References: