This intervention combines different elements of effective approaches including cognitive and behavioral treatment using accurate information on the effects of stimulants, relapse prevention skills training, 12-step program participation, and family education. Its manualized treatment protocol ensures fidelity when the model is implemented in different settings.Using SMS text messages with people who use methamphetamine has been shown to reduce methamphetamine use and HIV-related sexual transmission behaviors and increase retention in HIV care among some key populations. Scripted unidirectional texts outperform bidirectional interactive text-messaging conversations in reducing methamphetamine use and HIV sexual risk behaviors and are more cost-effective than in person therapies. Theory-driven messaging might better benefit people in the early stages of behavior change than people who are already seeking help.Despite some demonstrated efficacy, few studies have shown ways to optimize and combine treatment approaches for methamphetamine use disorders. Qualitative reports show patients found contingency management beneficial when combined with motivational interviewing and cognitive behavioral techniques for methamphetamine use disorders. Combined motivational interviewing and cognitive behavioral treatment show efficacy in reducing methamphetamine use in HIV-positive MSM. Evidence supports combining psychosocial treatment with medication-assisted treatment in people with OUD, but it is unclear whether patients with comorbid methamphetamine use disorder will experience similar benefits. Integrating screening and brief interventions, contingency management or conditional cash transfer,grow table and cognitive behavioral therapy for the management of substance use disorders requires trained health professionals.
This is challenging in settings where human resource for mental health/substance use is scarce. Therefore, besides identifying optimal combination of EBI, it is essential to recognize potential barriers to the implementation of these strategies. Our study named “Screen, Treat and Retain people with opioid use disorders who use methamphetamine in methadone clinics” proposes to explore these questions.The study deploys a type-1 effectiveness-implementation hybrid design to evaluate the effectiveness of the proposed adaptive interventions and gather data on the implementation. To evaluate the effectiveness of the interventions, the study employs a Sequential Multiple Assignment Randomized Trial design. In the first phase, participants will be randomized into two front line interventions for 12 weeks. Based on their outcome at the end of this phase, they will be placed or randomized into three adaptive strategies for another 12 weeks . The economic evaluation that addresses Aim 2 aims to weigh public health and societal costs against public health and societal benefits attributed to the interventions of different intensities with a time horizon of 12 months. To address Aim 3, we will conduct an ethnographic evaluation to identify the multi-level factors that influence the adoption and scale-up of the interventions in methadone clinics. The CFIR assesses five domains of interventions, outer settings, inner settings, provider characteristics, and participant characteristics. The evaluation includes pre- and post intervention in-depth interviews with key informants who participate in the study and ethnographic observation with participants in their daily activities at the clinics and in the community settings.In each selected clinic, a physician, two counselors, and one nurse will participate in the study as intervention providers. The physician will ensure referral to HIV and psychiatric services when necessary; two counselors will run motivational interviewing, group education sessions, and Matrix meetings; the nurse will collect urine twice a week and conduct contingency management based on the UDS results.
Before the start of the intervention, to ensure the accuracy,integrity, and fidelity to the EBIs, all intervention staff at methadone clinics will receive didactic training on the theory behind the approach, evaluate their comprehension of the concepts within and behind the approach, watch a video of a Master Behavioral Counselor conducting intervention sessions and discuss the details of the session, and conduct at least two pilot intervention instances. All intervention sessions, except contingency management, will be audio-recorded, transcribed, and coded to ensure intervention fidelity. Intervention staff who have lower levels of intervention integrity or who have significant drift will be provided detailed feedback and supervision until there is parity with other staff.Sample sizes were chosen to compare primary outcomes based on first-stage randomization into one of two groups: high intensity or low intensity front line interventions. Sample size calculations are conducted in PASS 2008 for a two-group comparison of binary outcomes, a power of 80%, a 5% alpha level, and a conservative attrition rate of 20%. Using estimates from our prior work, we anticipate base rates of 80 to 90% for substance use and 60 to 70% for viral suppression. Based on these assumptions and a proposed sample of 200 HIV-positive participants , we can detect randomization group differences of 20% or more for binary outcomes, such as substance use and viral load suppression. We can detect even smaller group differences for substance use outcomes in the proposed sample of 400 HIV-negative participants and the combined sample of HIV-positive and HIV-negative participants. If estimated outcome probabilities are similar between first-stage randomization groups at 12 weeks, we will pool 12-week results for even greater power in evaluating second-stage randomization differences.Different datasets collected from different sources will be linked through a unique identification code using RED Cap for quantitative data. Data will be uploaded in real-time from the 20 study clinics onto our database. The study data manager will assess transferred data for completeness, query sites regarding any inconsistencies, and code merged data files for analysis. For qualitative data, field notes written on site are expanded and recorded electronically within 24 h.
After removing all personal identifiable information, the research team will upload password-protected transcripts on a secured database. The transcripts will be uploaded into Atlas.ti software to organize data and facilitate analysis.We will use a time-varying mixed-effects model that will be fitted to the participants’ common outcome measures over time. The unadjusted model will include indicators of first-stage and second-stage intervention conditions,vertical rack time of the assessment , and intervention indicators-by-time interaction terms. An additional interaction term of the two intervention indicators will be included to account for any interaction effect between the first and the second stage interventions. The adjusted model will include patients’ socio-demographic characteristics, drug use history, HIV-serostatus, and location as fixed effects. The mixed effects models will include a participant-level random effect to account for repeated observations of each participant, as well as a clinic-level random effect to account for the nested nature within the clinics. We will conduct subgroup analyses among HIV positive and HIV-negative participants. For the HIV positive subgroup, the specific outcomes of interest include HIV viral load suppression and adherence to antiretroviral treatment, and specific outcomes for HIV-negative subgroup include frequency of HIV testing and HIV seroconversion. Substance use will be the common outcomes in models including participants of both HIV statuses.Our data monitoring committee is composed of members of the Data and Safety Monitoring Board for Addiction Medicine of the University of California – Los Angeles. These members are not connected to the study in any way. The DSMBAM is independent from the National Institute on Drug Abuse —the sponsor of this study. The DSMBAM meets quarterly to monitor subjects’ progress in the trial and considers whether adverse social harms differentially accrue by condition. Although there are no prospective stopping rules for this trial, the DSMBAM is within its charge to review aggregate data, request statistical tests of differences in social or other harms, and then advise changes in intervention type or intensity if statistically significant differences emerge in adverse events by condition. Prior to each meeting, the study team will submit a performance report including all reports of SAEs for DSMBAM’s consideration. After each meeting, recommendations will be made in writing to the principal investigators.Hanoi Medical University and the staff in the STAR-OM study provide oversight of financial management. The Vietnam teams and US teams maintain frequent communication via emails and bi-weekly online meetings to report updates on the study progress, discuss scientific aspects of the study, and troubleshoot issues when they arise. The teams in Hanoi and HCMC meet online once weekly and in-person quarterly during monitoring visits to discuss the study conduct. We submit annual research progress reports to the Ethics Committee of Hanoi Medical University. Any protocol amendments need to get ethical approval before implementation. The UCLA Addiction Medicine Data Safety Monitoring Board independently review our data and data management twice a year.Serious adverse events are defined as life-threatening events such or other events that have a negative impact on participants’ life such as incarceration or compulsory drug rehabilitation.
The clinic staff will communicate information about adverse events and serious adverse events to the study team right after they are informed by participants or participant families. The study coordinators in Hanoi and HCMC are responsible to report adverse events within 7 days and serious adverse events within 24 h on REDCap with the time of onset, seriousness, duration, and outcomes. The principal investigator will decide what serious adverse events need to be reported to the Ethics Committee.Prior to participation in the trial, the participant will be informed about the research. Participants will complete a short questionnaire about the study objectives and main activities to show how they understand the study. Research assistants will provide more explanation based on the results of the questionnaire. If participants agree to join the study, they will sign a consent form. Each participant will be assigned a unique identifier at the time of screening. Participant data will be linked to this identifier only. Participant personal identifiable information is stored in a separate locked cabinet to which only responsible study staff have access. All study staff sign a confidentiality agreement to non-disclosure of participant information. We make extra efforts to ensure nodisclosure of drug use information to anyone other than participants and the study staff.Between July and October 2020, we conducted 4 focus group discussions of a convenience sample of participants from four methadone clinics in the downtown and suburbs of Hanoi and HCMC to inform intervention content and refinement. Respondents reported information on local taxonomy and patterns of methamphetamine use, triggering situations, methamphetamine related sexual risks, motivations for seeking treatment, and perceived acceptability of the adaptive interventions. The pilot implementation lasted 12 weeks from November 2020 through February 2021. It identified issues to be addressed before the full implementation. At the conclusion of the pilot, we conducted 2 FGD with patients and 1 FGD with providers participating in the pilot to gauge their feedback about the interventions.With the cut-off point of ASSIST ≥ 4 and methamphetamine-positive UDS as originally proposed, there were 26 and 52 eligible participants in two pilot clinics in Hanoi and HCMC, respectively . For the pilot implementation, we randomly recruited 42 participants with ASSIST score ≥ 4 or methamphetamine-positive UDS. After the front line intervention, 16 participants were non-responders and randomized into adaptive interventions. At least 50% of the original sample must transition to the adaptive phase for sufficient statistical power. Thus, we decided to recruit more participants with severe use of methamphetamine, as evidenced in both ASSIST score ≥ 10 and methamphetamine-positive UDS. Furthermore, to recruit enough participants for the front line intervention phase, given most other clinics are smaller than the two pilot ones, we decided to use ASSIST score “OR” UDS instead of “AND” to increase the pool of potential participants. We kept the criterion of methamphetamine-positive UDS to compensate for participants with lower ASSIST scores due to desirability bias.The STAR-OM study is among the first studies to evaluate different combinations of EBIs for methamphetamine use among methadone patients in low-and-middle-income countries. The study will provide effectiveness and cost-effectiveness evidence for scaling up these interventions. The SMART design assesses different treatment strategies for participants who respond differently to front line interventions. The combination of trial and ethnographical study will provide insights on factors at multiple levels that need to be considered in decision making. The adaptation and pilot implementation of EBIs will make them culturally sound to local participants. As the interventions will be delivered by methadone providers at methadone clinics, they can be readily implemented if the trial demonstrates they help. The participation of some participants can be interrupted due to drug-related police arrest or methadone treatment fatigue. This limitation can be minimized as we will select clinics with low drop-out rates.