A mechanics theory for the exploration of a high-throughput, sterile 3D in vitro traumatic brain injury model.

Brain injuries resulting from mechanical trauma represent an ongoing global public health issue. Several in vitro and in vivo models for traumatic brain injury (TBI) continue to be developed for delineating the various complex pathophysiological processes involved in its onset and progression. Developing an in vitro TBI model that is based on cortical spheroids is especially of great interest currently because they can replicate key aspects of in vivo brain tissue, including its electrophysiology, physicochemical microenvironment, and extracellular matrix composition. Being able to mechanically deform the spheroids are a key requirement in any effective in vitro TBI model. The spheroids' shape and size, however, make mechanically loading them, especially in a high-throughput, sterile, and reproducible manner, quite challenging. To address this challenge, we present an idea for a spheroid-based, in vitro TBI model in which the spheroids are mechanically loaded by being spun by a centrifuge. (An experimental demonstration of this new idea will be published shortly elsewhere.) An issue that can limit its utility and scope is that imaging techniques used in 2D and 3D in vitro TBI models cannot be readily applied in it to determine spheroid strains. In order to address this issue, we developed a continuum mechanics-based theory to estimate the spheroids' strains when they are being spun at a constant angular velocity. The mechanics theory, while applicable here to a special case of the centrifuge-based TBI model, is also of general value since it can help with the further exploration and development of TBI models.

Developing the Open Psychedelic Evaluation Nexus consensus measures for assessment of supervised psilocybin services: An e-Delphi study.

BACKGROUND: Voter initiatives in Oregon and Colorado authorize legal frameworks for supervised psilocybin services, but no measures monitor safety or outcomes. AIMS: To develop core measures of best practices. METHODS: A three-phase e-Delphi process recruited 36 experts with 5 or more years' experience facilitating psilocybin experiences in various contexts (e.g., ceremonial settings, indigenous practices, clinical trials), or other pertinent psilocybin expertise. Phase I, an on-line survey with qualitative, open-ended text responses, generated potential measures to assess processes, outcomes, and structure reflecting high quality psilocybin services. In Phase II, experts used seven-point Likert scales to rate the importance and feasibility of the Phase I measures. Measures were priority ranked. Qualitative interviews and analysis in Phase III refined top-rated measures. RESULTS: Experts (n = 36; 53% female; 71% white; 56% heterosexual) reported currently providing psilocybin services (64%) for a mean of 15.2 [SD 13.1] years, experience with indigenous psychedelic practices (67%), and/or conducting clinical trials (36%). Thematic analysis of Phase I responses yielded 55 candidate process measures (e.g., preparatory hours with client, total dose of psilocybin administered, documentation of touch/sexual boundaries), outcome measures (e.g., adverse events, well-being, anxiety/depression symptoms), and structure measures (e.g., facilitator training in trauma informed care, referral capacity for medical/psychiatric issues). In Phase II and III, experts prioritized a core set of 11 process, 11 outcome, and 17 structure measures that balanced importance and feasibility. CONCLUSION: Service providers and policy makers should consider standardizing core measures developed in this study to monitor the safety, quality, and outcomes of community-based psilocybin services.

Perceptions of Community Corrections and Treatment Experience: A Qualitative Study Among People With Incarceration Histories Receiving Outpatient Methadone Treatment.

BACKGROUND: Community correctional experiences among individuals receiving methadone treatment (MT) for opioid use disorder (OUD) are poorly understood. We qualitatively investigated perceptions of community corrections and treatment experiences among individuals with criminal-legal system experience currently receiving outpatient MT. METHODS: From January to December 2017, we recruited 42 individuals with history of criminal-legal system involvement enrolled in outpatient MT at a low-barrier nonprofit organization operating multiple clinics in Connecticut. An experienced qualitative research team conducted one-to-one, in-person, semistructured interviews about incarceration and treatment experiences with individuals receiving MT. Participants completed a demographics survey. The interviews were audiorecorded, transcribed, de-identified, and independently coded using NVivo. RESULTS: Participants described the community corrections system as restrictive and abstinence-focused. Most participants described positive perceptions of and experiences with community corrections officers (CCOs), yet described negative perceptions of and experiences with the community corrections system overall. Participants perceived CCOs to have limited knowledge of OUD and MT. Participants described a range of CCO judgment toward their OUD, with some appearing understanding and nonjudgmental while others were perceived to have stigma and prejudice. Few participants noted assistance from CCOs with seeking MT or community-based substance use disorder care. Some participants desired improved treatment facilitation, but viewed forced or coercive treatment negatively. CONCLUSION: To our knowledge, this is the first qualitative study to examine community corrections experience among people receiving outpatient medication for OUD. While individuals receiving MT have negative experiences with the community corrections system, they perceive individual CCOs positively. Interventions addressing gaps in CCOs knowledge of OUD and MT are needed to optimize support for individuals on probation or parole with OUD. Provision of OUD treatment facilitation appears desirable to some individuals in community supervision.

A Quantitative Examination of Illness Models Among People With Opioid Use Disorder Receiving Methadone Treatment.

BACKGROUND: Few studies have examined illness models among people with addiction. We investigated illness models and their associations with demographics and treatment beliefs among patients receiving methadone treatment for opioid use disorder. METHODS: From January 2019 to February 2020, patients receiving methadone treatment at outpatient opioid treatment programs provided demographics and rated using 1 to 7 Likert-type scales agreement with addiction illness models (brain disease model, chronic medical condition model [CMCM], and no explanation [NEM]) and treatment beliefs. Pairwise comparisons and multivariate regressions were used to examine associations between illness models, demographics, and treatment beliefs. Statistical significance was set at P < 0.05. RESULTS: A total of 450 patients participated in the study. Forty percent self-identified as female, 13% as Hispanic, and 78% as White; mean age was 38.5 years. Brain disease model was the most frequently endorsed illness model (46.2%), followed by CMCM (41.7%) and NEM (21.9%). In multivariate analyses, agreement with brain disease model was significantly positively associated with beliefs that methadone treatment would be effective, counseling is important, and methadone is lifesaving, whereas agreement with CMCM was significantly positively associated with beliefs that methadone treatment would be effective, counseling is important, 12-step is the best treatment, taking methadone daily is important, and methadone is lifesaving. In multivariate analyses, agreement with NEM was negatively significantly associated with beliefs that methadone would be effective, counseling is important, taking methadone daily is important, and methadone is lifesaving. DISCUSSION: Many patients in methadone treatment endorsed medicalized addiction models. Agreement with addiction illness models appear to be related to treatment beliefs.

Engaging the Great Circle: a qualitative study of the Confederated Tribes of Grand Ronde's mobile medication unit

BACKGROUND: The Confederated Tribes of the Grand Ronde Community of Oregon began a Mobile Medication Unit (MMU) as part of their Great Circle Recovery Opioid Treatment Program (OTP) to address elevated rates of opioid use disorder (OUD) among American Indians and Alaska Natives in Oregon. The MMU provides methadone or buprenorphine for individuals with OUD, enrolled in the OTP, who are living either on the reservation or in surrounding rural communities. An implementation study describes the service through document review and qualitatively assesses patient and staff experiences and the perceived barriers and facilitators to mobile services. METHODS: Semi-structured qualitative interviews with patients (n = 11), MMU staff (n = 5), and the state opioid treatment authority (n = 1) gathered details on the initiative's development and operations. Provider interviews probed implementation experiences. Patient interviews focused on their experiences with the MMU and staff, changes in quality of life and recommendations for enhancing treatment. Interviews were transcribed and analysed using a Thematic Analysis approach. RESULTS: Staff themes identified two driving forces (i.e. staff desire for an inclusive approach to wellness that is accessible to all community members; the catalysts for the MMU), two steps toward MMU development (i.e. Tribal approvals and support; the construction and maintenance of community relationships) and two perspectives on MMU implementation and impact (i.e. initial implementation barriers; facilitators and observations of how the MMU reduced stigma associated with agonist therapy). Patients' themes noted the MMU's professional and 'caring' environment, accessible rural locations and general suggestions including culturally responsive ancillary services. CONCLUSION: The Great Circle MMU enhanced access to opioid agonist therapy for people with OUD (i.e. American Indians/Alaska Natives, and non-natives) living in rural communities. The Confederated Tribes of Grand Ronde operates the first Tribally owned OTP MMU, grounded in cultural humility and committed to Tribal members and the great circle of the larger community.

Usability and feasibility of a take-home methadone web-application for opioid treatment program patients: A Small Business Innovation Research mixed methods study.

BACKGROUND: Most patients in opioid treatment programs (OTPs) attend daily for observed dosing. A Stage IA (create and adapt) and a Stage IB (feasibility and pilot) mixed method studies tested a web-application (app) designed to facilitate access to take-home methadone. METHODS: A Stage IA, intervention development study, used qualitative interviews to assess the usability (ease of use) and feasibility (ability to implement) of a take-home methadone app. The Stage IA market research was a two-week test with 96 patient participants from four OTPs. Qualitative interviews were completed with 20 systematically selected individuals who used the take-home app and 20 OTP clinicians (five each from the four OTPs). The Stage IB Small Business Innovation Research (SBIR) study (24 patients and 8 clinicians in a single OTP) included quantitative assessments of the app's usability, acceptability, appropriateness, and feasibility. Thematic analysis coded participant and staff assessments of the take-home app. RESULTS: Stage IA patients (mean age = 41 years; 52 % men, 57 % White) and IB patients (mean age = 38 years, 54 % men, 79 % White) described the app as "easy to use." Compared to unsupervised take-homes, some patients preferred using the take-home app. In Stage IB, patients rated the app highly on standardized measures of usability, acceptability, appropriateness, and feasibility. Clinician ratings were more ambivalent. Patients rated in-clinic dosing as more disruptive than unsupervised take-homes and take-homes using the app. DISCUSSION: A Stage IA study informed the development and maturation of a Stage IB feasibility pilot study. Overall, the take-home app's usability, acceptability, appropriateness, and feasibility were rated positively. Clinical staff ratings were less positive, but individuals commented that using the app a) enhanced patient quality of life, b) provided new tools for counselors, and c) offered competitive advantages. The SBIR award enhanced market research with more complete and systematic data collection and analysis.

Treatment Initiation, Substance Use Trajectories, and the Social Determinants of Health in Persons Living With HIV Seeking Medication for Opioid Use Disorder.

BACKGROUND: People living with HIV and opioid use disorder (OUD) are disproportionally affected by adverse socio-structural exposures negatively affecting health, which have shown inconsistent associations with uptake of medications for OUD (MOUD). This study aimed to determine whether social determinants of health (SDOH) were associated with MOUD uptake and trajectories of substance use in a clinical trial of people seeking treatment. METHODS: Data are from a 2018 to 2019 randomized trial comparing the effectiveness of different MOUD to achieve viral suppression among people living with HIV and OUD. SDOH were defined by variables mapping to Healthy People 2030 domains: education (Education Access and Quality), income (Economic Stability), homelessness (Neighborhood and Built Environment), criminal justice involvement (Social and Community Context), and recent SUD care (Health Care Access and Quality). Associations between SDOH and MOUD initiation were assessed with Cox proportional hazards models, and SDOH and substance use over time with generalized estimating equation models. RESULTS: Participants (N = 114) averaged 47 years old, 63% were male, 56% were Black, and 12% Hispanic. Participants reported an average of 2.3 out of 5 positive SDOH indicators (SD = 1.2). Stable housing was the most commonly reported SDOH (61%), followed by no recent criminal justice involvement (59%), having a high-school level education or greater (56%), income stability (45%), and recent SUD care (13%). Each additional favorable SDOH was associated with a 25% increase in the likelihood of MOUD initiation during the study period [adjusted HR = 1.25, 95% CI = (1.01, 1.55), P = .044]. Positive SDOH were also associated with a decrease in the odds of baseline opioid use and a greater reduction in opioid use during subsequent weeks of the study (P < .001 for a joint test of baseline and slope differences). CONCLUSIONS: Positive social determinants of health, in aggregate, may increase the likelihood of MOUD treatment initiation among people living with HIV and OUD.

Patient-provider relationships: Opioid use disorder and HIV treatment in Vietnam.

Background: The provider-patient relationship has been implicated as a positive force in health outcomes. This study examined the provider-patient relationship in the setting of integrated, partially-integrated, and non-integrated opioid use disorder (OUD) and HIV care models in Vietnam. Objective: To examine the provider-patient relationship in the setting of integrated, partially integrated, and non-integrated OUD and HIV treatment in North Vietnam. Methods: Between 2013 and 2018, we conducted face-to-face qualitative interviews with 44 patients living with HIV and OUD and 43 providers in northern Vietnam. These were analyzed using a semantic, inductive approach to qualitative thematic analysis. Results: Several themes were identified. 1) Trust was important to the patient-provider relationship and sensitive to provider attitudes and competence. 2) Patients perceived greater provider competence and understanding of patient health problems in integrated treatment. 3) Patient-provider relationships were initially superficial but deepened over time, facilitated by continuity of care. Conclusions: Patient perceptions of competence and respect were important to feeling cared for. Providers felt empathy and competence came with more experience caring for patients with OUD and HIV.

"Just fighting for my life to stay alive": a qualitative investigation of barriers and facilitators to community re-entry among people with opioid use disorder and incarceration histories.

BACKGROUND: During the period of community re-entry immediately following release from jail or prison, individuals with opioid use disorder (OUD) face structural barriers to successful re-entry and high risk of overdose. Few published studies investigate experiences in the immediate period (i.e., first 24 h) of re-entry among people with OUD. AIM: To understand the barriers and facilitators to treatment and reintegration of people with OUD during the initial transition from carceral settings back into the community. METHODS: From January-December 2017, we conducted 42 semi-structured qualitative interviews with patients with a history of incarceration who were receiving methadone at a not-for-profit, low-barrier opioid treatment program. Interviews probed participants' community re-entry experiences immediately following incarceration. Interviews were transcribed and analyzed using a Thematic Analysis approach. RESULTS: The main themes described the experiences during the 24 h following release, reacclimating and navigating re-entry barriers, and re-entry preparedness and planning. Participants noted the initial 24 h to be a period of risk for returning to substance use or an opportunity to engage with OUD treatment as well as a tenuous period where many lacked basic resources such as shelter or money. When discussing the subsequent re-entry period, participants noted social challenges and persistent barriers to stable housing and employment. Participants overall described feeling unprepared for release and suggested improvements including formal transition programs, improved education, and support to combat the risk of overdose and return to substance use after incarceration. CONCLUSIONS: In this study that qualitatively examines the experiences of people with incarceration histories and OUD enrolled in methadone treatment, we found that participants faced many barriers to community re-entry, particularly surrounding basic resources and treatment engagement. Participants reported feeling unprepared for release but made concrete suggestions for interventions that might improve the barriers they encountered. Future work should examine the incorporation of these perspectives of people with lived experience into the development of transition programs or re-entry classes.

The process and challenges of language translation and cultural adaptation of study instruments: a case study from the NIDA CTN CHOICES-2 trial.

BACKGROUND: As the U.S. grows more diverse, researchers decide how to include non-English speakers. Budget limitations may not allow for translation of all instruments. Study teams must determine which instruments must receive certified translations. This paper describes the procedures utilized in one U.S.-based, multi-site clinical trial to decide which study instruments should undergo certified translation and discusses dialect review procedures. METHODS: The team determined which instruments (n = 31) would be translated using a qualitative evaluation to determine the need to obtain a Spanish-language certified translation: 1) "Could the meaning of these questions change (and potentially elicit a different response) if the translations were not consistent?" and 2) "Is it acceptable to have potential inconsistencies in these data?" Instruments for which question 1 was "yes" and question 2 was "no" (e.g., eligibility, outcomes, safety) were marked for certified translation. A dialect committee reviewed all translated patient-reported outcome measures to ensure that the translations had accounted for different meanings of words based on respondents' countries or regions of origin and recommended changes where necessary. RESULTS: Fourteen interview-based instruments underwent certified forward-only translation into U.S. Spanish. The remaining 2 interview-based instruments were translated via real-time conversation with participants by bilingual staff. Six forms were administrative and not translated. Five out of 9 professionally translated patient-reported outcome measures were amended to better reflect relevant dialects. CONCLUSIONS: In the absence of specific guidance, it is feasible for study team members to 1) determine which instruments should undergo certified translation and 2) incorporate dialect into translations.

Recruitment challenges for a prospective telehealth cohort study.

Background: The COVID-19 pandemic presents challenges in participant recruitment strategies for clinical research involving people with opioid use disorders recently engaged in treatment. We describe challenges to participant recruitment in a trial comparing virtual buprenorphine treatment platform to office-based buprenorphine treatment. Methods: The parent study was a cohort trial of telehealth delivered buprenorphine treatment compared to office-based buprenorphine treatment, however, due to the pandemic potential participant recruitment for both arms became virtual. Between 9/27/2021 and 7/11/2022, telephone, email, flyers, and word-of-mouth were used to recruit study participants from each treatment setting. Recruitment tracking documents recorded the primary outcomes: number of outreach attempts and most effective contact methods. Results: Treatment settings provided contact information for 1485 potential study participants. Information was incorrect or disconnected for 282 (19%) individuals, 695 (47%) did not respond to outreach, and 508 (34%) responded to outreach. Of these responders, 369 were interested in study participation, 259 completed the online informed consent and screening assessment, and 148 met eligibility criteria and enrolled in the study. A total of 3804 virtual outreach attempts across 1485 potential participants were made, resulting in an average of 2.7 attempts per contact and a mean of 25.7 attempts per enrolled participant (n = 148). Conclusion: Conducting research during the COVID-19 pandemic required shifting from in-person to virtual recruitment strategies to contact and engage potential study participants. Virtual recruitment for this population during a pandemic appears to be less efficient and hindered efforts to meet recruitment goals.

Patient evaluation of a smartphone application for telehealth care of opioid use disorder.

BACKGROUND: People with opioid use disorder (OUD) face barriers to entering and remaining in life-saving treatment (e.g., stigma, detrimental interactions with health care, and privacy concerns). Telehealth and related technology can reduce barriers to entering and staying in care. Patient feedback is critical to the development of these newer treatment approaches to ensure they are usable and do not inadvertently recreate treatment barriers. PURPOSE: Evaluate the perceived usability of existing and planned features of a mobile application (app) that facilitates delivery of OUD treatment via telehealth. METHODS: People with current or prior experience with OUD treatment were eligible for the study. Participants (n = 31; 55% women) provided feedback on an interactive prototype demonstration via individual qualitative interviews and completed a quantitative survey on the app's perceived usability. Descriptive statistics summarized the usability survey. We analyzed qualitative interview transcripts to elicit common themes. RESULTS: Participants were primarily white (77%) with a mean age of 42.2 years (range 22-69). Participants rated the six major features of the current app as helpful (median response 5 out of 5) and appreciated the flexibility of conducting a visit from a place of their choosing. Participants regarded the five proposed components of the app, such as daily affirmations and medication treatment-related reminders (e.g., pick up medication at pharmacy, medication schedule), as useful features with medians 5 out of 5, and reported they would recommend the app to others for OUD care. Participant qualitative interviews provided additional information on perceived usability of existing and proposed app features. CONCLUSION: Our study suggests that an appealing, easy-to-use app-with tools and features that effectively support care-could circumvent existing barriers and foster sustained recovery.

Perceived Stress, Resilience, and Wellbeing in Seasoned Isha Yoga Practitioners Compared to Matched Controls During the COVID-19 Pandemic.

Background: Yoga practices, including breathing, meditation, and posture protocols (asanas), have been shown to facilitate physical and mental wellbeing. Methods: Seasoned yoga practitioners were recruited from the Isha Foundation. Recruitment of the comparison group was achieved using snowball sampling and were not yoga practitioners. Participants in the non-yoga group were randomized to a 3-min Isha practice or a comparator group asked to perform 15-min of daily reading. Participants completed a series of web-based surveys (REDCap) at baseline, 6, and 12 weeks. These surveys include validated scales and objective questions on COVID-19 infection and medical history. The validated questionnaires assess for: perceived stress (PSS), mood states [anxiety and depression (PHQ-4), joy (DPES-Joy subscale)], mindfulness attention and awareness (MAAS), resilience (BRS), mental wellbeing (WEMWBS) and recovery from traumatic event (PTGI). Weekly activity diaries were employed as a tool for collecting compliance information from study participants. Perceived stress scale scores were identified as primary outcome for this study. Findings: The median Perceived Stress Scale (PSS) score for the yoga practitioners compared to the active and placebo comparators was significantly lower at all time-points: baseline: 11 [IQR 7-15] vs. 16 [IQR 12-21] in both the active and placebo comparators (p < 0.0001); 6 weeks: 9 [IQR 6-13] vs. 12 [IQR 8-17] in the active comparator and 14 [IQR 9-18] in the placebo comparator (p < 0.0001); and 12 weeks: 9 [IQR 5-13] vs. 11.5 [IQR 8-16] in the active comparators and 13 [IQR 8-17] in the placebo comparator (p < 0.0001). Among the randomized participants that were compliant for the full 12 weeks, the active comparators had significantly lower median PSS scores than the placebo comparators 12 weeks [10 (IQR 5-14) vs. 13 (IQR 8-17), p = 0.017]. Further, yoga practitioners had significantly lower anxiety at all three-time points (p < 0.0001), lower depression at baseline and 6 weeks (p < 0.0003), and significantly higher wellbeing (p < 0.0001) and joy (p < 0.0001) at all three-time points, compared to the active and placebo comparator groups. Interpretation: The lower levels of stress, anxiety, depression, and higher level of wellbeing and joy seen in the yoga practitioners compared to the active and placebo comparators illustrate the impact of regular yoga practices on mental health even during the pandemic. Trial Registration: ClinicalTrials.gov, identifier: NCT04498442.

Stigma as a barrier to integrated substance use and HIV care in Vietnam: A qualitative examination of patient and provider perspectives.

Integration of substance use disorder (SUD) treatment and HIV care can increase antiretroviral therapy coverage among people with opioid use disorder (OUD). However, implementation of integrated treatment models remains limited. Stigma towards people with OUD poses a barrier to initiation of, and adherence to, HIV treatment. We sought to understand the extent of stigma towards SUD and HIV among people with OUD in Vietnam, and the effect of stigma on integrated OUD and HIV treatment services utilization. Between 2013 and 2015, we conducted in-depth interviews with 43 patients and 43 providers at 7 methadone clinics and 8 HIV clinics across 4 provinces in Vietnam. We used thematic analysis with a mixed deductive and inductive approach at the semantic level to analyze key topics. Two main themes were identified: (1) Confidentiality concerns about HIV status make patients reluctant to receive integrated care at HIV clinics, given the requirements for daily buprenorphine dosing at HIV clinics. (2) Provider stigma existed mostly toward people with OUD and seemed to center on the belief that substance use causes a deterioration in one's morals, and was most frequently manifested in the form of providers' apprehensive approach towards patients. Concerns regarding stigmatization may cause patients to feel reluctant to receive treatment for both OUD and HIV at a single integrated clinic. Interventions to reduce stigma at the clinic and policy levels may thus serve to improve initiation of and adherence to integrated care.

Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.

OBJECTIVES: In March 2020, the Substance Abuse and Mental Health Services Administration permitted Opioid Treatment Programs (OTPs) to relax restrictions on take-home methadone and promoted telehealth to minimize potential exposures to COVID-19. We assessed the effects of COVID-19-related changes on take-home methadone dosing in two OTPs serving five rural Oregon counties. METHODS: We used a mixed-methods convergent design. The OTPs extracted urine drug test (UDT) results, take-home methadone regimens, and treatment retention from the electronic health record (EHR) for patients (n = 377). A mixed-effects negative binomial regression model assessed patient-level differences in take-home doses before and after the COVID-19 policy changes and the associations with treatment discontinuation, and UDT positivity. Semi-structured qualitative interviews (n = 32) explored patient reactions to increased take-home dosing and reduced clinic visits to provide context for quantitative findings. RESULTS: The number of take-home doses increased in the post-COVID-19 period for patients engaged in treatment for more than 180 days (median: 8 vs 13 take-home doses per month, p = 0.011). Take-homes did not increase for patients with fewer days of treatment. Each percentage point increase in take-home dosing above what would be expected without COVID-19 policy changes was negatively associated with the percent of UDT positive for opioids (B = -0.12, CI [-0.21, -0.04], p = 0.005) and the probability of treatment discontinuation (aOR = 0.97, CI [0.95, 0.99], p = 0.003). Qualitative analysis revealed three themes explaining how increased take-home dosing supported recovery: 1) value of feeling trusted with increased responsibility; 2) reduced travel time permitted increased employment and recreation; and 3) reduced exposure to individuals less stable in recovery and potential triggers. CONCLUSIONS: Take-home methadone dose relaxations were associated with increased methadone take-home doses, improved retention, and decreased UDT opioid positive results among clinically stable patients. Qualitative findings suggest that fewer take-home restrictions are feasible and desirable and do not pose safety or public health harms.

Familial support in integrated treatment with antiretroviral therapy and medications for opioid use disorder in Vietnam: A qualitative study.

Background: Patients report that familial support can facilitate initiation and maintenance of antiretroviral therapy (ART) and medications for opioid use disorder (MOUD). However, providing such support can create pressure and additional burdens for families of people with opioid use disorder (OUD) and HIV. We examined perspectives of people with HIV receiving treatment for OUD in Vietnam and their family members. Methods: Between 2015 and 2018, we conducted face-to-face qualitative interviews with 44 patients and 30 of their family members in Hanoi, Vietnam. Participants were people living with HIV and OUD enrolled in the BRAVO study comparing HIV clinic-based buprenorphine with referral to methadone treatment at 4 HIV clinics and their immediate family members (spouses or parents). Interviews were professionally transcribed, coded in Vietnamese, and analyzed using a semantic, inductive approach to qualitative thematic analysis. Results: Family members of people with OUD and HIV in Vietnam reported financially and emotionally supporting MOUD initiation and maintenance as well as actively participating in treatment. Family members described the burdens of supporting patients during opioid use, including financial costs and secondary stigma. Conclusions: Describing the role of family support in the lives of people living with OUD and HIV in the context of Vietnam enriches our understanding of their experiences and will support future treatment efforts targeting the family unit.

HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.

BACKGROUND AND AIM: Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results. DESIGN: Open-label, non-inferiority randomized trial. SETTING: Six US HIV primary care clinics. PARTICIPANTS: A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment. INTERVENTION: HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59). MEASUREMENTS: Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks. FINDINGS: Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2). CONCLUSIONS: A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.

Incarceration and compulsory rehabilitation impede use of medication for opioid use disorder and HIV care engagement in Vietnam.

BACKGROUND: Non-prescribed opioid use is illegal in Vietnam. People who are apprehended for use of non-prescribed opioids may be arrested and incarcerated or sent to compulsory rehabilitation centers. For those on medication to treat opioid use disorder (MOUD), incarceration in either setting may disrupt treatment. This study estimates the effects of incarceration and compulsory rehabilitation on MOUD and HIV treatment outcomes in Vietnam. METHODS: Data are from a clinical trial testing the effects of MOUD on HIV viral suppression in six Vietnamese HIV clinics. Participants were assessed quarterly for 12 months. We assessed the associations between incarceration or compulsory rehabilitation during months 0-9 and study outcomes of receipt of MOUD, HIV clinic engagement, and antiretroviral therapy prescription during months 9-12, among those who were released by month 9 of the study, using logistic regression and zero-inflated negative binomial models. RESULTS: At nine months, 25 of 258 participants (9.7%) were incarcerated or sent to compulsory rehabilitation at least once and completed the month 9 assessment. Of those, 19 (76.0%) did not receive MOUD in months 9 through 12. Both incarceration and compulsory rehabilitation were negatively associated with subsequent receipt of MOUD (aOR = 0.05, 95% CI = (0.01, 0.24); 0.14 (0.04, 0.50), respectively) and HIV clinic engagement (aOR = 0.13, 95% CI = (0.03, 0.71); 0.09 (0.02, 0.39), respectively). In the final three months of the study, participants who were incarcerated had 42.5 fewer days of MOUD (95% CI = 23.1, 61.9), and participants in compulsory rehabilitation had 46.1 fewer days of MOUD (95% CI = 33.8, 58.4) than those not incarcerated or in compulsory rehabilitation. CONCLUSION: Our findings suggest that both incarceration and compulsory rehabilitation disrupt MOUD and HIV treatment among people with HIV and Opioid Use Disorder in Vietnam. Prioritization of evidence-based strategies to support engagement in care for people who use drugs could potentially expand HIV and Opioid Use Disorder treatment access and curb substance use more effectively than reliance on incarceration or compulsory rehabilitation.

Recruitment into a Clinical Trial of People Living with Uncontrolled HIV Infection Who Inject Drugs: a Site Case Report from the CTN 67 CHOICES Study.

CHOICES was an open-label, randomized, comparative effectiveness trial of office-based extended-release naltrexone versus treatment as usual in people with untreated opioid use disorder and HIV. This study explored facilitators to recruitment in Miami, a successful recruiting site in the national trial. The mixed-methods study included quantitative surveys of randomized participants, medical record abstraction, and qualitative interviews with study staff. Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In-depth interviews of study staff (n = 6) revealed that Miami had a recruitment approach consisting of street level outreach and a close relationship with the local syringe services program (SSP). Partnership with a local SSP provided access to people living with HIV who inject drugs in Miami. SSPs' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.