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临床试验/NCT04798534
NCT04798534已完成不适用

Facilitating the Decentralization of Methadone Maintenance Therapy Services Into Communities in Vietnam

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Patients' adherence to MMT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Intervention group

Experimental

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.

干预措施: Service decentralization facilitation intervention (Behavioral)

Control group

No Intervention

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

结局指标

主要结局

Patients' adherence to MMT

时间窗: From baseline to 6-month

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.

CHW's service provision for MMT providers

时间窗: From baseline to 6-month

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.

CHW's service provision for MMT providers

时间窗: From baseline to 3-month

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.

Patients' adherence to MMT

时间窗: From baseline to 3-month

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.

次要结局

  • Patients' level of satisfaction with community-based services(From baseline to 6-month)
  • Patients' addiction and HIV-related service utilization(From baseline to 6-month)
  • 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(From baseline to 6-month)
  • Patients' service preference(From baseline to 6-month)
  • CHW's stigma associated with substance use(From baseline to 6-month)
  • CHW's level of adherence to the working procedure(From baseline to 6-month)
  • CHW's perceived challenges and administrative burdens in treating MMT patients(From baseline to 6-month)
  • CHW's job satisfaction(From baseline to 6-month)
  • CHW's stigma associated with HIV(From baseline to 6-month)
  • Patients' level of satisfaction with community-based services(From baseline to 3-month)
  • Patients' service preference(From baseline to 3-month)
  • Patients' addiction and HIV-related service utilization(From baseline to 3-month)
  • CHW's level of adherence to the working procedure(From baseline to 3-month)
  • 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(From baseline to 3-month)
  • CHW's perceived challenges and administrative burdens in treating MMT patients(From baseline to 3-month)
  • CHW's job satisfaction(From baseline to 3-month)
  • CHW's stigma associated with substance use(From baseline to 3-month)
  • CHW's stigma associated with HIV(From baseline to 3-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunqing Lin, PhD

Principal Investigator

University of California, Los Angeles

研究点 (1)

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