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Completed

NCT Number: NCT04798534

Intervention to Facilitate MMT/HIV Service Decentralization in Vietnam

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Service decentralization facilitation intervention

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.

Primary outcomes

  1. CHW's service provision for MMT providers

    Time frame: 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.

  2. CHW's service provision for MMT providers

    Time frame: 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.

  3. Patients' adherence to MMT

    Time frame: 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.

  4. Patients' adherence to MMT

    Time frame: 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.

Secondary outcomes

  1. Patients' level of satisfaction with community-based services

    Time frame: From baseline to 3-month

    This outcome will be measured using the change in the Verona Service Satisfaction Scale for Methadone Treatment (VSSS-MT; Range: 7-28; higher score indicates higher level of service satisfaction)

  2. Patients' level of satisfaction with community-based services

    Time frame: From baseline to 6-month

    This outcome will be measured using the change in the Verona Service Satisfaction Scale for Methadone Treatment (VSSS-MT; Range: 7-28; higher score indicates higher level of service satisfaction)

  3. Patients' service preference

    Time frame: From baseline to 3-month

    This outcome will be measured by change in patients' indicated preference between centralized healthcare agencies and CHC when they have a list of hypothetical health conditions (including mental health issues, infectious diseases, when seeking HIV testing and treatment, and STI treatment etc.)

  4. Patients' service preference

    Time frame: From baseline to 6-month

    This outcome will be measured by the change in patients' indicated preference between centralized healthcare agencies and CHC when they have a list of hypothetical health conditions (including mental health issues, infectious diseases, when seeking HIV testing and treatment, and STI treatment etc.)

  5. Patients' addiction and HIV-related service utilization

    Time frame: From baseline to 3-month

    This outcome will be measured by the change in the number of recorded service encounters with service providers during the last three months. Specifically, HIV/AIDS-related service utilization, including HIV testing and diagnosis will be documented at baseline and every follow-up point during the study period.

  6. Patients' addiction and HIV-related service utilization

    Time frame: From baseline to 6-month

    This outcome will be measured by the change in the number of recorded service encounters with service providers during the last three months. Specifically, HIV/AIDS-related service utilization, including HIV testing and diagnosis will be documented at baseline and every follow-up point during the study period.

  7. CHW's level of adherence to the working procedure

    Time frame: From baseline to 3-month

    This outcome will be measured using the change in score of an adapted version of Primary Care Behavioral Health Provider Adherence Questionnaire (PPAQ).The scale consists of three subscales to measure the CHW's favorable, acceptable, and prohibited clinical behaviors as specified in the revised protocol (range: 20-100; higher score indicates higher level of adherence to the working procedure).

  8. CHW's level of adherence to the working procedure

    Time frame: From baseline to 6-month

    This outcome will be measured using the change in score of an adapted version of Primary Care Behavioral Health Provider Adherence Questionnaire (PPAQ).The scale consists of three subscales to measure the CHW's favorable, acceptable, and prohibited clinical behaviors as specified in the revised protocol (range: 20-100; higher score indicates higher level of adherence to the working procedure).

  9. 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

    Time frame: From baseline to 3-month

    This outcome will be measured using the change in CHW's service knowledge, assessed using a set of true-or-false questions based on the previously developed assessments (range 0-17; higher score indicates' better knowledge in harm reduction and HIV/AIDS).

  10. 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

    Time frame: From baseline to 6-month

    This outcome will be measured using the change in CHW's service knowledge, assessed using a set of true-or-false questions based on the previously developed assessments (range 0-17; higher score indicates' better knowledge in harm reduction and HIV/AIDS).

  11. CHW's perceived challenges and administrative burdens in treating MMT patients

    Time frame: From baseline to 3-month

    This outcome will be measured using change in CHW's perceived challenge and administrative burdens in treating MMT patients, from recruitment, retention to provide referrals/consultations, using the Connecticut Primary Care Survey items (range: 13-52; higher score indicates higher level of perceived challenges and burdens).

  12. CHW's perceived challenges and administrative burdens in treating MMT patients

    Time frame: From baseline to 6-month

    This outcome will be measured using change in CHW's perceived challenge and administrative burdens in treating MMT patients, from recruitment, retention to provide referrals/consultations, using the Connecticut Primary Care Survey items (range: 13-52; higher score indicates higher level of perceived challenges and burdens).

  13. CHW's job satisfaction

    Time frame: From baseline to 3-month

    This outcome will be measured using change in CHW's level of satisfaction with various aspects of their career and specialty, including practice in addictive treatment, working hours, working environment, and income (Bellingham's Job Satisfaction Survey; range: 17-65; higher score indicates higher level of job satisfaction).

  14. CHW's job satisfaction

    Time frame: From baseline to 6-month

    This outcome will be measured using change in CHW's level of satisfaction with various aspects of their career and specialty, including practice in addictive treatment, working hours, working environment, and income (Bellingham's Job Satisfaction Survey; range: 17-65; higher score indicates higher level of job satisfaction).

  15. CHW's stigma associated with substance use

    Time frame: From baseline to 3-month

    This outcome will be measured using change in CHW's substance use stigma using Substance Abuse Attitudes Survey (SAAS; range: 7-35; higher score indicates higher level of stigmatizing attitude towards patients who use substances).

  16. CHW's stigma associated with substance use

    Time frame: From baseline to 6-month

    This outcome will be measured using change in CHW's substance use stigma using Substance Abuse Attitudes Survey (SAAS; range: 7-35; higher score indicates higher level of stigmatizing attitude towards patients who use substances).

  17. CHW's stigma associated with HIV

    Time frame: From baseline to 3-month

    This outcome will be measured using change in CHW's HIV stigma using adapted items of Substance Abuse Attitudes Survey (adapted SAAS; range: 7-35; higher score indicates higher level of stigmatizing attitude towards patients living with HIV).

  18. CHW's stigma associated with HIV

    Time frame: From baseline to 6-month

    This outcome will be measured using change in CHW's HIV stigma using adapted items of Substance Abuse Attitudes Survey (adapted SAAS; range: 7-35; higher score indicates higher level of stigmatizing attitude towards patients living with HIV).

Other outcomes

  1. MMT patients' mental health

    Time frame: From baseline to 3-month

    This outcome will be measured using the change in the Patient Health Questionnaire (PHQ-9), without the last item measuring suicidal ideation (range 0-24; higher score indicates worse mental health).

  2. MMT patients' mental health

    Time frame: From baseline to 6-month

    This outcome will be measured using the change in the Patient Health Questionnaire (PHQ-9), without the last item measuring suicidal ideation (range 0-24; higher score indicates worse mental health).

  3. MMT patients' heroin use

    Time frame: From baseline to 3-month

    This outcome will be measured using the change in patients' self-reported heroin use in the past 30 days (yes/no).

  4. MMT patients' heroin use

    Time frame: From baseline to 6-month

    This outcome will be measured using the change in patients' self-reported heroin use in the past 30 days (yes/no).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 15, 2021
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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