Intervention to Facilitate MMT/HIV Service Decentralization in Vietnam
Facilitating the Decentralization of Methadone Maintenance Therapy Services Into Communities in Vietnam
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2020
CompletedFirst Submitted
Initial submission to the registry
March 4, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedMay 31, 2023
May 1, 2023
7 months
March 4, 2021
May 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
CHW's service provision for MMT providers
This outcome will be evaluated using the change in CHW's self-reported number of hours in a typical week they spend on providing services for their MMT patients in the following areas: treatment adherence and retention, physical and mental health, employment status, family issues, STI/HIV risk reduction, and healthcare utilization.
From baseline to 3-month
CHW's service provision for MMT providers
This outcome will be evaluated using the change in CHW's self-reported number of hours in a typical week they spend on providing services for their MMT patients in the following areas: treatment adherence and retention, physical and mental health, employment status, family issues, STI/HIV risk reduction, and healthcare utilization.
From baseline to 6-month
Patients' adherence to MMT
This outcome will be measured using the change in the number of days the client received an MMT dosage divided by the total number of days during an observation period. Any occurrence of a special event (including termination of MMT, a positive urine test, and/or a dosage change) will be documented in detail.
From baseline to 3-month
Patients' adherence to MMT
This outcome will be measured using the change in the number of days the client received an MMT dosage divided by the total number of days during an observation period. Any occurrence of a special event (including termination of MMT, a positive urine test, and/or a dosage change) will be documented in detail.
From baseline to 6-month
Secondary Outcomes (18)
Patients' level of satisfaction with community-based services
From baseline to 3-month
Patients' level of satisfaction with community-based services
From baseline to 6-month
Patients' service preference
From baseline to 3-month
Patients' service preference
From baseline to 6-month
Patients' addiction and HIV-related service utilization
From baseline to 3-month
- +13 more secondary outcomes
Other Outcomes (4)
MMT patients' mental health
From baseline to 3-month
MMT patients' mental health
From baseline to 6-month
MMT patients' heroin use
From baseline to 3-month
- +1 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALCHW in the intervention arm will receive intervention through a combination of in-person training sessions and internet support. MMT patients in the intervention arm can use a specially designed online platform to communicate with their CHW.
Control group
NO INTERVENTIONThe control group CHW will perform business as usual. Both control group CHW and MMT patients do not have access to the online platform.
Interventions
The intervention CHW will participate in three 60-minute intervention weekly sessions. During the intervention, CHW will be provided with the knowledge and skills to serve their MMT patients. The intervention sessions will also focus on enhancing the current service decentralization workflow so that the CHW can work with both their peer providers and their patients more efficiently. Two-times booster sessions will be offered before the 3- and 6-month survey for continued skill building for problem-solving. In addition to the group sessions, the intervention arm CHW will be encouraged to use a specially designed online platform to review the current policy and scientific findings, review their patients' treatment status, communicate with other providers, and provide instant consulting to their MMT patients. The MMT patients in the intervention condition can use the online platform to communicate with their CHW and view education materials disseminated by their MMT providers or CHW.
Eligibility Criteria
You may qualify if:
- Age 18 or over
- Currently seeking MMT services in one of the participating commune health centers
- Voluntary informed consent
You may not qualify if:
- 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):
- Age 18 or over
- Currently working in one of the participating commune health centers and have direct contact with MMT clients
- Providing informed consent
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 4, 2021
First Posted
March 15, 2021
Study Start
August 28, 2020
Primary Completion
March 30, 2021
Study Completion
August 31, 2022
Last Updated
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Upon request
After all data are de-identified, cleaned, and validated, and main findings are published, the study team will make study data available upon request with the scientific community. Data sets will be made available to those who make a direct request to the PI and indicate the data will be used for the purposes of research. No identifiers will be included in these data sets. Depending on the request, data may be made available only in the form of codebooks and aggregated frequencies, to protect participant confidentiality. The names of the communes where data are collected may not be released beyond the immediate study team to further protect the privacy of participants.