Opioid-use DisorderNCT04798534
Intervention to Facilitate MMT/HIV Service Decentralization in Vietnam
A study testing Service decentralization facilitation intervention in people with Opioid-use Disorder, run by University of California, Los Angeles at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Service decentralization facilitation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Aug 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facilitating the Decentralization of Methadone Maintenance Therapy Services Into Communities 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.
Read the 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
- Being tested
- Service decentralization facilitation intervention
- Keywords
- Vietnam, Service Decentralization, Methadone maintenance therapy, HIV, Community health setting
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service decentralization facilitation interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Service decentralization facilitation intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 6-month
Secondary outcomes (18)
Patients' level of satisfaction with community-based services
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)
Measured: From baseline to 3-month
Patients' level of satisfaction with community-based services
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)
Measured: From baseline to 6-month
Patients' service preference
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.)
Measured: From baseline to 3-month
Patients' service preference
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.)
Measured: From baseline to 6-month
Patients' addiction and HIV-related service utilization
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.
Measured: From baseline to 3-month
Patients' addiction and HIV-related service utilization
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.
Measured: From baseline to 6-month
CHW's level of adherence to the working procedure
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).
Measured: From baseline to 3-month
CHW's level of adherence to the working procedure
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).
Measured: 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
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).
Measured: 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
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).
Measured: From baseline to 6-month
CHW's perceived challenges and administrative burdens in treating MMT patients
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).
Measured: From baseline to 3-month
CHW's perceived challenges and administrative burdens in treating MMT patients
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).
Measured: From baseline to 6-month
CHW's job satisfaction
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).
Measured: From baseline to 3-month
CHW's job satisfaction
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).
Measured: From baseline to 6-month
CHW's stigma associated with substance use
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).
Measured: From baseline to 3-month
CHW's stigma associated with substance use
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).
Measured: From baseline to 6-month
CHW's stigma associated with HIV
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).
Measured: From baseline to 3-month
CHW's stigma associated with HIV
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).
Measured: From baseline to 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start28 Aug 2020
- Primary completion30 Mar 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Chunqing Lin, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798534
- Sponsor's protocol ID
- R34DA04378
- Other IDs
- R34DA043783
- Status last verified
- May 2023
- First submitted
- 4 Mar 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Decentralization of Methadone Maintenance Therapy Services Into Communities in Vietnam
- ClinicalTrials.gov ID
- NCT04798534
- Acronym / sponsor ID
- R34DA04378
- Conditions
- Opioid-use Disorder
- Keywords
- Vietnam, Service Decentralization, Methadone maintenance therapy, HIV, Community health setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, National Institute on Drug Abuse (NIDA)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Service decentralization facilitation interventionCHW 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Service decentralization facilitation interventionThe 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
18 secondary outcomes
Patients' level of satisfaction with community-based services
Time frame: From baseline to 3-month
Patients' level of satisfaction with community-based services
Time frame: From baseline to 6-month
Patients' service preference
Time frame: From baseline to 3-month
Patients' service preference
Time frame: From baseline to 6-month
Patients' addiction and HIV-related service utilization
Time frame: From baseline to 3-month
Patients' addiction and HIV-related service utilization
Time frame: From baseline to 6-month
CHW's level of adherence to the working procedure
Time frame: From baseline to 3-month
CHW's level of adherence to the working procedure
Time frame: 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
Time frame: 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
Time frame: From baseline to 6-month
CHW's perceived challenges and administrative burdens in treating MMT patients
Time frame: From baseline to 3-month
CHW's perceived challenges and administrative burdens in treating MMT patients
Time frame: From baseline to 6-month
CHW's job satisfaction
Time frame: From baseline to 3-month
CHW's job satisfaction
Time frame: From baseline to 6-month
CHW's stigma associated with substance use
Time frame: From baseline to 3-month
CHW's stigma associated with substance use
Time frame: From baseline to 6-month
CHW's stigma associated with HIV
Time frame: From baseline to 3-month
CHW's stigma associated with HIV
Time frame: From baseline to 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Opioid-use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Service decentralization facilitation intervention in people with Opioid-use Disorder, run by University of California, Los Angeles at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHW's service provision for MMT providers (time frame: From baseline to 3-month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.