Intervention to Facilitate MMT/HIV Service Decentralization in Vietnam

NCT ID: NCT04798534

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2022-08-31

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

CHW 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.

Group Type: EXPERIMENTAL

Service decentralization facilitation intervention

Intervention Type: BEHAVIORAL

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.

Control group

The control group CHW will perform business as usual. Both control group CHW and MMT patients do not have access to the online platform.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Service decentralization facilitation intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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):

• Inability to provide informed consent

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

Sponsors

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Chunqing Lin, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Hygiene and Epidemiology

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

R34DA043783

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R34DA04378

Identifier Type: -

Identifier Source: org_study_id