Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706624
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2021-01-04
Brief Title:
Screen Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
Sponsor:
Hanoi Medical University
Organization:
Hanoi Medical University
Study Overview
Official Title:
Screen Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-OM
Brief Summary:
The investigators propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use hereafter meth use among people with opioid use disorder who are in methadone maintenance therapy MMT in Vietnam Over the past decade the expansion of MMT has contributed to stemming both HIV and opioid epidemics However rising meth use threatens these achievements
Evidence-based interventions such as Motivational Enhancement Therapy Contingency Management Matrix Model and SMS reminders are effective in reducing meth use The study will be conducted in the two largest cities in Vietnam Hanoi and Ho Chi Minh City HCMC where there are the highest number of MMT patients and the highest burden of HIV cases Building on the pilot work of the research team in Hanoi through collaborative work with local MMT providers and patients the investigators will first further refine adapted EBIs to develop adaptive strategies The adaptive design includes 1 Two frontline interventions 6 weeks of contingency management then 6 weeks of weekly group educational sessions and 12 weeks of contingency management 2 One short-term tailoring outcome urine tests negative with meth metabolites in both week 11 and 12 are considered responsive to frontline interventions 3 Three alternative interventions those with positive outcomes will move to 12-week maintenance stage and receive two daily SMS reminders plus one weekly self-monitoring assessment messages Non-responders will move to 12-week enhanced treatment stage and are randomly assigned to either Matrix group counseling only or Matrix group counseling plus contingency management
The full randomization trial will be conducted with 200 HIV-positive and 400 HIV-negative MMT patients who report moderate- and high-risk meth use on self-screening with ASSIST or have urine positive with meth metabolites In each location the study will stratify participants by HIV status before randomizing them to one of two frontline interventions Primary outcomes - including HIV viral suppression HIV risk behaviors and meth use reported and urine tests - will be assessed at 12 24 and 48 weeks The study team also conducts ethnographic observations and in-depth interviews with MMT clinic managers clinical staff and MMT patients to explore implementation barriers and facilitators
Evidence-based interventions such as Motivational Enhancement Therapy Contingency Management Matrix Model and SMS reminders are effective in reducing meth use The study will be conducted in the two largest cities in Vietnam Hanoi and Ho Chi Minh City HCMC where there are the highest number of MMT patients and the highest burden of HIV cases Building on the pilot work of the research team in Hanoi through collaborative work with local MMT providers and patients the investigators will first further refine adapted EBIs to develop adaptive strategies The adaptive design includes 1 Two frontline interventions 6 weeks of contingency management then 6 weeks of weekly group educational sessions and 12 weeks of contingency management 2 One short-term tailoring outcome urine tests negative with meth metabolites in both week 11 and 12 are considered responsive to frontline interventions 3 Three alternative interventions those with positive outcomes will move to 12-week maintenance stage and receive two daily SMS reminders plus one weekly self-monitoring assessment messages Non-responders will move to 12-week enhanced treatment stage and are randomly assigned to either Matrix group counseling only or Matrix group counseling plus contingency management
The full randomization trial will be conducted with 200 HIV-positive and 400 HIV-negative MMT patients who report moderate- and high-risk meth use on self-screening with ASSIST or have urine positive with meth metabolites In each location the study will stratify participants by HIV status before randomizing them to one of two frontline interventions Primary outcomes - including HIV viral suppression HIV risk behaviors and meth use reported and urine tests - will be assessed at 12 24 and 48 weeks The study team also conducts ethnographic observations and in-depth interviews with MMT clinic managers clinical staff and MMT patients to explore implementation barriers and facilitators
Detailed Description:
1 To develop adaptive interventions including two frontline interventions and four adaptive strategies through collaborative processes Aim 1 During Month 3 - 9 the investigators refine the EBIs to develop adaptive interventions
1a Assessment The team conducts 4 Focus Group Discussions FGDs with MMT patients on local taxonomy and patterns of meth use trigger situations motivations for seeking treatment motivations and barriers for participating in different EBIs inputsadvice on proposed adaptive design and barriers and facilitators for retention of participants in each of the adaptive steps
1b Decision The team organizes a workgroup that involves MMT clinical staff representatives of CBOs working with people who use drugs social workers working with MMT patients and MMT patients themselves to review the contents of FGDs in the Assessment step experiences of pilot intervention in Hanoi the conceptual and empirical evidence of EBIs to make recommendations on core contents of each EBI
Contingency management is a 12-week or 6-week low-value escalating schedule Participants give urine twice a week Matrix group counseling involves twice weekly group sessions that last for about 60 to 90 minutes each Group counseling focuses on relapse prevention SMS-text Participants receive automated unidirectional scripted theory-based and culturally responsive text reminders twice daily plus a weekly self-monitoring assessment messages The text messages are scripted across 1 drug use sexual risk reduction physical health and HIV care for HIV participants and 2 the theoretical construct of cognitive-behavioral therapy including understanding external and internal triggers relapse prevention and relapse analysis and goal setting
1c Administration At the end of the Decision step the workgroup put together a framework for the adaptive design that include different interventions sequence decision rule and contents of interventions This framework is presented and discussed in a second round of FGDs with target populations in each city
2 Pilot implementation of adaptive interventions Aim 1 During Month 3 - 9 the study team chooses one MMT clinic in each city for piloting the adaptive design The pilot implementation which lasts 12 weeks aims to identify issues that need to be addressed before the full implementation The pilot recruits 40 meth-using MMT patients 20 from each city at least 10 HIV positive and over-recruits women Inclusion criteria for the pilot sample include 1 16 years old or older 2 score of 4-26 moderate risk or 27 high risk on ASSIST regarding meth use OR urine screen positive for metabolite of meth 4 having a cell phone able to receive texts 5 and willing to participate in treatment These participants are excluded from the full implementation
2a Pilot Monitoring and Evaluation The study team in each city monitors the overall operation of the pilot to ensure that interventions are carried out as planned For each intervention session a Master Behavioral Counselor and an ethnographer observe the implementation regarding content integrity flow location message clarity interventionist-participant interaction participant attendance engagement and responsiveness Second after each phase of intervention implementation self-screening frontline interventions decision stage maintenance enhanced treatment a FGD is organized for all intervention facilitators and another with patients to understand their experiences and to gather feedback regarding potential modifications
2b Intervention modification and assessment finalization The evaluation data helps to identify factors that may affect implementation and outcomes Modifications to intervention characteristics to ensure the relevance of the intervention for target settings and populations are completed at this stage This phase gives an opportunity to finalize the recruitment and retention strategies as well as assessment tools
3 Full implementation of SMART design to compare effectiveness of two frontline interventions and four adaptive strategies Aim 1 3a Selection of clinical settings to become intervention sites Criteria for selecting clinics are established Existing statistics are viewed and clinics that meet criteria are shortlisted 20 MMT clinics are selected randomly from the shortlisted candidates 10 from Hanoi 10 from HCMC
3b Intervention facilitator recruitment and training The intervention team in each city includes one Master Behavioral Counselor with Master-level training in clinical psychology and two intervention coaches with bachelor degrees in social work psychology or public health to support and ensure quality of implementation of the EBIs by MMT clinical staff Both Master Counselor and intervention coaches are also facilitators for Matrix group counseling where MMT clinical staff will not be able to carry out themselves
Once MMT clinics are selected managers of these clinics nominate a physician two counselors and one nurse to participate in the study as intervention facilitators Before the start of intervention all intervention staff at MMT clinics 1 receive didactic training on the theory behind the approach 2 pass a knowledge test to evaluate their grasp of the concepts within and behind the approach 3 watch a video of a Master Behavioral Counselor conducting intervention sessions and discuss the details of the session and 4 conduct at least two pilot EBIs which are recorded and observed by the HMUUMP intervention team and the PIs All subsequent interventions are audio recorded and coded to ensure the presence of essential elements of the intervention Intervention staffs who have lower levels of intervention integrity or who have significant drift are provided detailed feedback and supervision
3c Participant recruitment and randomization The 20 selected clinics are randomly assigned into 5 clusters 4 clusters of 4 clinics from the same city and 1 cluster of 4 clinics from two cities In each cluster CBO members and health care staff distribute flyers and CBO members working in each MMT clinic approach patients when patients come daily for their MMT dosages to invite them to participate in self-screening with tablet-based ASSIST as well as urine drug test and Quick HIV tests Once agreed CBO assist with self-screening processes Individuals who participate in self-screening give verbal agreement to participate and receive compensation for their time Those with low-risk scores and urine negative with meth metabolites are offered a Brief Intervention by trained CBO members Those with reactive Quick HIV tests are referred to HIV care facilities if these participants have not done so
Recruiting participants for adaptive interventions
CBO members invite those who are at moderate-risk and high-risk scores for meth or have urine positive with meth metabolites to participate in the study Those who express interest and provide contact information are referred to research assistants RA who then makes appointment to screen for eligibility At each clinic RA conduct a brief survey and collect urine sample to confirm recent meth use The study over-recruits women as the majority of MMT patients in Vietnam are men The study aims to recruit 200 HIV and 400 HIV- Those who sign informed consent are enrolled in baseline assessment and electronically fingerprinted to create unique ID Participants receive compensation for their participation in baseline assessment Eligible participants at each clinic are first stratified by HIV status and then randomized to low vs high intensity frontline interventions
4 Cost-effectiveness analysis of interventions Aim 2 4a The cost-effectiveness analysis has two goals 1 to determine whether any additional improvement in outcomes associated with interventions of different intensity and expense is worth the additional cost and 2 to provide guidance to the Vietnam Ministry of Health on the cost of scaling-up and implementing the interventions This analysis measures the increment in cost between contrasted interventions divided by the increment in outcomes Effectiveness of each intervention for HIV and HIV- groups is measured by the estimated outcome probabilities for each outcome of interest as in Aim 1
4b Costs are assessed from the point of view of the public health agency The second analysis will include social costs Implementation costs are calculated based on costs for each arm incurred by health care providers including costs of implementing the intervention mental health and drug treatment services used An activity-based costing approach is used to estimate the cost of fielding the interventions in 20 MMT clinics A template is used to collect data on salaries for personnel and consultants physical resources clinical supplies and miscellaneous charges that are required to deliver each intervention type Data is collected from participants on medical visits and involvement with the criminal justice system These differences are costed out using local pricing data Per capita costs for each intervention are calculated by dividing the total cost for each sitearm by the number of participants in each arm at that site
5 Ethnographic evaluation to identify the structural provider and patient-level factors that influence adoption and scale-up of interventions in MMT clinics Aim 3
5a Ethnographic interviews Two ethnographic researchers conduct pre-post intervention in-depth interviews with 12 individuals in each cluster of clinics Participants include MMT manager MMT clinical staff CBO members and patients who participate in interventions In each cluster at least 6 patients are selected In-depth ethnographic interviews with these individuals take place immediately before enrollment and immediately after maintenance or enhanced treatments end
With CBO and MMT staff pre-intervention interviews explore experiences with current work experiences with meth users expectations of whether and how the interventions would work Post-intervention interviews explore actual experiences with delivering interventions as well as perceived barriers and facilitators for adoption and scale-up
With participants first interviews explore family of origin childhood and coming of age histories of sexual and affective relations histories of drug use and patterns of meth use current social support broader life goals motivations to participate in the study and expectations of how the interventions would work Second interviews explore actual experiences and outcomes as well as motivations to stay in the interventions
The Consolidated Framework for Implementation Research is used in all interviews to probe participant perceptions of the characteristics of the STAR-OM interventions of outer settings inner settings provider characteristics and the implementation process
5b Ethnographic Observation Two kinds of observations take place The first carried out with in-depth interviews of participants who consent to participate in this additional form of data collection involves having two ethnographers spend time with them to observe activities such as individual meetings group activities and other daily activities in the clinical andor community settings The second element of observation involve Master Counselors to observe randomly selected sessions of interventions in CM and CBT period and keep a logbook of SMS messages that are sent out to each participant in the study A checklist is used to assess the fidelity of interventions contents and delivery Master Counselors also assess other contextual information that is useful to determine whether interventions are effectively delivered All observation periods are recorded with detailed field notes
1a Assessment The team conducts 4 Focus Group Discussions FGDs with MMT patients on local taxonomy and patterns of meth use trigger situations motivations for seeking treatment motivations and barriers for participating in different EBIs inputsadvice on proposed adaptive design and barriers and facilitators for retention of participants in each of the adaptive steps
1b Decision The team organizes a workgroup that involves MMT clinical staff representatives of CBOs working with people who use drugs social workers working with MMT patients and MMT patients themselves to review the contents of FGDs in the Assessment step experiences of pilot intervention in Hanoi the conceptual and empirical evidence of EBIs to make recommendations on core contents of each EBI
Contingency management is a 12-week or 6-week low-value escalating schedule Participants give urine twice a week Matrix group counseling involves twice weekly group sessions that last for about 60 to 90 minutes each Group counseling focuses on relapse prevention SMS-text Participants receive automated unidirectional scripted theory-based and culturally responsive text reminders twice daily plus a weekly self-monitoring assessment messages The text messages are scripted across 1 drug use sexual risk reduction physical health and HIV care for HIV participants and 2 the theoretical construct of cognitive-behavioral therapy including understanding external and internal triggers relapse prevention and relapse analysis and goal setting
1c Administration At the end of the Decision step the workgroup put together a framework for the adaptive design that include different interventions sequence decision rule and contents of interventions This framework is presented and discussed in a second round of FGDs with target populations in each city
2 Pilot implementation of adaptive interventions Aim 1 During Month 3 - 9 the study team chooses one MMT clinic in each city for piloting the adaptive design The pilot implementation which lasts 12 weeks aims to identify issues that need to be addressed before the full implementation The pilot recruits 40 meth-using MMT patients 20 from each city at least 10 HIV positive and over-recruits women Inclusion criteria for the pilot sample include 1 16 years old or older 2 score of 4-26 moderate risk or 27 high risk on ASSIST regarding meth use OR urine screen positive for metabolite of meth 4 having a cell phone able to receive texts 5 and willing to participate in treatment These participants are excluded from the full implementation
2a Pilot Monitoring and Evaluation The study team in each city monitors the overall operation of the pilot to ensure that interventions are carried out as planned For each intervention session a Master Behavioral Counselor and an ethnographer observe the implementation regarding content integrity flow location message clarity interventionist-participant interaction participant attendance engagement and responsiveness Second after each phase of intervention implementation self-screening frontline interventions decision stage maintenance enhanced treatment a FGD is organized for all intervention facilitators and another with patients to understand their experiences and to gather feedback regarding potential modifications
2b Intervention modification and assessment finalization The evaluation data helps to identify factors that may affect implementation and outcomes Modifications to intervention characteristics to ensure the relevance of the intervention for target settings and populations are completed at this stage This phase gives an opportunity to finalize the recruitment and retention strategies as well as assessment tools
3 Full implementation of SMART design to compare effectiveness of two frontline interventions and four adaptive strategies Aim 1 3a Selection of clinical settings to become intervention sites Criteria for selecting clinics are established Existing statistics are viewed and clinics that meet criteria are shortlisted 20 MMT clinics are selected randomly from the shortlisted candidates 10 from Hanoi 10 from HCMC
3b Intervention facilitator recruitment and training The intervention team in each city includes one Master Behavioral Counselor with Master-level training in clinical psychology and two intervention coaches with bachelor degrees in social work psychology or public health to support and ensure quality of implementation of the EBIs by MMT clinical staff Both Master Counselor and intervention coaches are also facilitators for Matrix group counseling where MMT clinical staff will not be able to carry out themselves
Once MMT clinics are selected managers of these clinics nominate a physician two counselors and one nurse to participate in the study as intervention facilitators Before the start of intervention all intervention staff at MMT clinics 1 receive didactic training on the theory behind the approach 2 pass a knowledge test to evaluate their grasp of the concepts within and behind the approach 3 watch a video of a Master Behavioral Counselor conducting intervention sessions and discuss the details of the session and 4 conduct at least two pilot EBIs which are recorded and observed by the HMUUMP intervention team and the PIs All subsequent interventions are audio recorded and coded to ensure the presence of essential elements of the intervention Intervention staffs who have lower levels of intervention integrity or who have significant drift are provided detailed feedback and supervision
3c Participant recruitment and randomization The 20 selected clinics are randomly assigned into 5 clusters 4 clusters of 4 clinics from the same city and 1 cluster of 4 clinics from two cities In each cluster CBO members and health care staff distribute flyers and CBO members working in each MMT clinic approach patients when patients come daily for their MMT dosages to invite them to participate in self-screening with tablet-based ASSIST as well as urine drug test and Quick HIV tests Once agreed CBO assist with self-screening processes Individuals who participate in self-screening give verbal agreement to participate and receive compensation for their time Those with low-risk scores and urine negative with meth metabolites are offered a Brief Intervention by trained CBO members Those with reactive Quick HIV tests are referred to HIV care facilities if these participants have not done so
Recruiting participants for adaptive interventions
CBO members invite those who are at moderate-risk and high-risk scores for meth or have urine positive with meth metabolites to participate in the study Those who express interest and provide contact information are referred to research assistants RA who then makes appointment to screen for eligibility At each clinic RA conduct a brief survey and collect urine sample to confirm recent meth use The study over-recruits women as the majority of MMT patients in Vietnam are men The study aims to recruit 200 HIV and 400 HIV- Those who sign informed consent are enrolled in baseline assessment and electronically fingerprinted to create unique ID Participants receive compensation for their participation in baseline assessment Eligible participants at each clinic are first stratified by HIV status and then randomized to low vs high intensity frontline interventions
4 Cost-effectiveness analysis of interventions Aim 2 4a The cost-effectiveness analysis has two goals 1 to determine whether any additional improvement in outcomes associated with interventions of different intensity and expense is worth the additional cost and 2 to provide guidance to the Vietnam Ministry of Health on the cost of scaling-up and implementing the interventions This analysis measures the increment in cost between contrasted interventions divided by the increment in outcomes Effectiveness of each intervention for HIV and HIV- groups is measured by the estimated outcome probabilities for each outcome of interest as in Aim 1
4b Costs are assessed from the point of view of the public health agency The second analysis will include social costs Implementation costs are calculated based on costs for each arm incurred by health care providers including costs of implementing the intervention mental health and drug treatment services used An activity-based costing approach is used to estimate the cost of fielding the interventions in 20 MMT clinics A template is used to collect data on salaries for personnel and consultants physical resources clinical supplies and miscellaneous charges that are required to deliver each intervention type Data is collected from participants on medical visits and involvement with the criminal justice system These differences are costed out using local pricing data Per capita costs for each intervention are calculated by dividing the total cost for each sitearm by the number of participants in each arm at that site
5 Ethnographic evaluation to identify the structural provider and patient-level factors that influence adoption and scale-up of interventions in MMT clinics Aim 3
5a Ethnographic interviews Two ethnographic researchers conduct pre-post intervention in-depth interviews with 12 individuals in each cluster of clinics Participants include MMT manager MMT clinical staff CBO members and patients who participate in interventions In each cluster at least 6 patients are selected In-depth ethnographic interviews with these individuals take place immediately before enrollment and immediately after maintenance or enhanced treatments end
With CBO and MMT staff pre-intervention interviews explore experiences with current work experiences with meth users expectations of whether and how the interventions would work Post-intervention interviews explore actual experiences with delivering interventions as well as perceived barriers and facilitators for adoption and scale-up
With participants first interviews explore family of origin childhood and coming of age histories of sexual and affective relations histories of drug use and patterns of meth use current social support broader life goals motivations to participate in the study and expectations of how the interventions would work Second interviews explore actual experiences and outcomes as well as motivations to stay in the interventions
The Consolidated Framework for Implementation Research is used in all interviews to probe participant perceptions of the characteristics of the STAR-OM interventions of outer settings inner settings provider characteristics and the implementation process
5b Ethnographic Observation Two kinds of observations take place The first carried out with in-depth interviews of participants who consent to participate in this additional form of data collection involves having two ethnographers spend time with them to observe activities such as individual meetings group activities and other daily activities in the clinical andor community settings The second element of observation involve Master Counselors to observe randomly selected sessions of interventions in CM and CBT period and keep a logbook of SMS messages that are sent out to each participant in the study A checklist is used to assess the fidelity of interventions contents and delivery Master Counselors also assess other contextual information that is useful to determine whether interventions are effectively delivered All observation periods are recorded with detailed field notes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None