Contextual barriers and enablers to establishing an addiction-focused consultation team for hospitalized adults with opioid use disorder.

BACKGROUND: Hospitalization presents an opportunity to begin people with opioid use disorder (OUD) on medications for opioid use disorder (MOUD) and link them to care after discharge; regrettably, people admitted to the hospital with an underlying OUD typically do not receive MOUD and are not connected with subsequent treatment for their condition. To address this gap, we launched a multi-site randomized controlled trial to test the effectiveness of a hospital-based addiction consultation team (the Substance Use Treatment and Recovery Team (START)) consisting of an addiction medicine specialist and care manager team that provide collaborative care and a specified intervention to people with OUD during the inpatient stay. Successful implementation of new practices can be impacted by organizational context, though no previous studies have examined context prior to implementation of addiction consultation services (ACS). This study assessed pre-implementation context for implementing a specialized ACS and tailoring it accordingly. METHODS: We conducted semi-structured interviews with hospital administrators, physicians, physician assistants, nurses, and social workers at the three study sites between April and August 2021 before the launch of the pragmatic trial. Using an analytical framework based on the Consolidated Framework for Implementation Research, we completed a thematic analysis of interview data to understand potential barriers or enablers and perceptions about acceptability and feasibility. RESULTS: We interviewed 28 participants across three sites. The following themes emerged across sites: (1) START is an urgently needed model for people with OUD; (2) Intervention adaptations are recommended to meet local and cultural needs; (3) Linking people with OUD to community clinicians is a highly needed component of START; (4) It is important to engage stakeholders across departments and roles throughout implementation. Across sites, participants generally saw a need for change from usual care to support people with OUD, and thought the START was acceptable and feasible to implement. Differences among sites included tailoring the START to support the needs of varying patient populations and different perceptions of the prevalence of OUD. CONCLUSIONS: Hospitals planning to implement an ACS in the inpatient setting may wish to engage in a systematic pre-implementation contextual assessment using a similar framework to understand and address potential barriers and contextual factors that may impact implementation. Pre-implementation work can help ensure the ACS and other new practices fit within each unique hospital context.

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study.

BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are highly effective for treating HCV infection even among people who inject drugs (PWID). Yet, little is known about patients' adherence patterns and their association with sustained virologic response (SVR) rates. We aimed to summarize various adherence patterns and determine their associations with SVR. METHODS: Electronic blister packs were used to measure daily adherence to once-a-day sofosbuvir/velpatasvir during the 12-week treatment period among active PWIDs. Blister pack data were available for 496 participants who initiated DAAs for whom SVR status was known. Adherence was summarized in multiple patterns, such as total adherent days, consecutive missed days, and early discontinuations. Thresholds for adherence patterns associated with >90% SVR rates were also determined. RESULTS: The overall SVR rate was 92.7%, with a median adherence rate of 75%. All adherence patterns indicating greater adherence were significantly associated with achieving SVR. Participant groups with ≥50% (>42/84) adherent days or <26 consecutive missed days achieved an SVR rate of >90%. Greater total adherent days during 9-12 weeks and no early discontinuation were significantly associated with higher SVR rates only in those with <50% adherence. Participants with first month discontinuation and ≥2 weeks of treatment interruption had low SVR rates, 25% and 85%, respectively. However, greater adherent days were significantly associated with SVR (adjusted odds ratio 1.10; 95% CI 1.04-1.16; p <0.001) even among participants with ≥14 consecutive missed days. CONCLUSIONS: High SVR rates can be achieved in the PWID population despite suboptimal adherence. Encouraging patients to take as much medication as possible, with <2 weeks consecutive missed days and without early discontinuation, was found to be important for achieving SVR. IMPACT AND IMPLICATIONS: People who inject drugs can be cured of HCV in >90% of cases, even with relatively low adherence to direct-acting antivirals, but early discontinuations and long treatment interruptions can significantly reduce the likelihood of achieving cure. Clinicians should encourage people who inject drugs who are living with HCV to adhere daily to direct-acting antivirals as consistently as possible, but if any days are interrupted, to continue and complete treatment. These results from the HERO study are important for patients living with HCV, clinicians, experts writing clinical guidelines, and payers. CLINICAL TRIAL NUMBER: NCT02824640.

The Cascade of Care for Early Psychosis Detection in a College Counseling Center.

OBJECTIVE: Programs for early detection of psychosis help identify individuals experiencing emerging psychosis and link them with appropriate services, thereby reducing the duration of untreated psychosis (DUP). The authors used the cascade-of-care framework to identify various care stages between screening and enrollment in coordinated specialty care (CSC) and to determine attrition at each stage, with the goal of identifying points in the referral process that may affect DUP. METHODS: Project partners included a college counseling center and CSC program. All college students seeking mental health services at a counseling center between 2020 and 2022 (N=1,945) completed the Prodromal Questionnaire-Brief (PQ-B) at intake. Students who met the distress cutoff score were referred for a phone screening. Those who met criteria on the basis of this screening were referred for assessment and possible enrollment into CSC. RESULTS: Six stages in the cascade of care for early detection were identified. Of the students who completed the PQ-B as part of intake (stage 1), 547 (28%) met the PQ-B cutoff score (stage 2). Counselors referred 428 (78%) students who met the PQ-B cutoff score (stage 3), and 212 (50%) of these students completed the phone screening (stage 4). Seventy-two (34%) students completed a CSC eligibility assessment (stage 5), 21 (29%) of whom were enrolled in CSC (stage 6). CONCLUSIONS: The cascade-of-care framework helped conceptualize the flow within a program for early psychosis detection in order to identify stages that may contribute to lengthier DUP. Future research is warranted to better understand the factors that contribute to DUP at these stages.

Association of Cytomegalovirus (CMV) DNAemia With Long-Term Mortality in a Randomized Trial of Preemptive Therapy and Antiviral Prophylaxis for Prevention of CMV Disease in High-Risk Donor Seropositive, Recipient Seronegative Liver Transplant Recipients.

In a post-hoc analysis of the association of CMV DNAemia with long-term mortality in a randomized trial of CMV preemptive therapy vs. antiviral prophylaxis in D+R- liver transplant recipients, post-intervention CMV DNAemia was associated with increased mortality after adjusting for study arm.

Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study.

BACKGROUND: Objective adherence measures, such as electronic blister pack (BP), for direct-acting antivirals (DAAs) for hepatitis C virus (HCV) treatment have high accuracy, but their use is limited in real practice settings. We examined the association of self-reported adherence using a visual analogue scale (VAS) with objective BP adherence and sustained virologic response (SVR) among people who inject drugs. METHODS: We conducted secondary analyses using a subset of participants (N = 493) from the per-protocol sample of the HERO study, a pragmatic randomized trial of HCV treatment interventions that used both VAS and BP to measure adherence to a 12-week sofosbuvir/velpatasvir DAA regimen. Multivariable mixed-effects regression models tested the association of self-report adherence level with longitudinal weekly objective adherence. Multivariable logistic regression tested the association of self-report adherence with SVR. RESULTS: The average VAS and BP adherences were 95.1 % (SD = 8.9 %) and 76.0 % (16.0 %), respectively, and the proportion of the participants achieving SVR was 92.9 %. The estimated adjusted mean objective adherence was significantly different (-16 %; 95 % CI: -22 %, -11 %, p < .001) between participants with 100 % and <80 % VAS adherence. The likelihood of SVR was significantly lower for those with <80 % VAS adherence [adjusted OR = 0.07; 95 % CI: 0.02, 0.24; p < .001] compared to those with 100 %. CONCLUSION: Self-reported adherence overestimated objective adherence. However, higher self-report adherence was significantly associated with higher objective adherence. Also, self-reported adherence ≥80 % was significantly associated with SVR. Thus, the self-report measure has utility as a monitoring tool for adherence during DAA treatment.

A Systematic Review and Meta-analysis of Optimized CMV Preemptive Therapy and Antiviral Prophylaxis for CMV Disease Prevention in CMV High-Risk (D+R-) Kidney Transplant Recipients.

The optimal strategy for cytomegalovirus (CMV) disease prevention in CMV donor/recipient kidney transplant recipients remains uncertain. Conclusions of prior meta-analyses that CMV disease rates with preemptive therapy (PET) and universal prophylaxis (UP) were comparable may have been affected by inclusion of studies lacking key determinants of efficacy of the respective strategies. Methods: We conducted a systematic review and meta-analysis of PET with weekly CMV polymerase chain reaction monitoring for ≥3 mo and UP with 6 mo of valganciclovir. PubMed and Embase databases were reviewed from January 1, 2010, to April 1, 2022. Risk of bias was assessed with 3 instruments (Cochrane RoB, Cochrane RoBINS-I, and an instrument for assessing risk in observational studies). The primary outcome was CMV disease incidence by 1-y posttransplant. Secondary outcomes by 1-y were graft loss, acute allograft rejection, and mortality. Results were synthesized using generalized linear mixed model meta-analysis. PET studies were stratified into low-threshold (LT) and high-threshold (HT) PET based on the viral load threshold for initiation of antiviral therapy. Results: Twenty-five studies met inclusion criteria (6 PET, 19 UP). CMV disease incidence was significantly higher in HT (0.30 [95% confidence interval (CI), 0.22-0.39]) versus LT PET (0.06 [95% CI, 0.03-0.12]). LT PET was associated with a significantly lower CMV disease incidence (0.06 [95% CI, 0.03-0.12]) versus UP (0.21 [95% CI, 0.17-0.27]). Incidence of graft loss, acute allograft rejection, or mortality was not significantly different between LT PET and UP (P > 0.05 for all comparisons). Receipt of lymphocyte-depleting antibodies was not associated with a significant difference in CMV disease incidence (odds ratio = 1.34 [95% CI, 0.80-2.25]). Conclusions: LT PET is associated with a significantly lower incidence of CMV disease compared to UP with similar rates of other clinical outcomes. These findings provide rationale and preliminary data for a randomized superiority trial of optimized LT-PET versus UP in donor seropositive recipient seronegative kidney transplant recipients.

Injecting practices during and after hepatitis C treatment and associations with not achieving cure among persons who inject drugs.

BACKGROUND: Persons who inject drugs (PWID) are a key population for hepatitis C virus (HCV) treatment. Study aims were to describe injection practices of PWID during HCV treatment with direct-acting antivirals (DAAs) and assess whether injection practices were associated with not achieving a sustained virologic response (SVR). METHODS: Secondary analysis of the HERO Study (ClinicalTrials.gov, NCT02824640), a pragmatic randomized trial in 8 U.S. states to evaluate the effectiveness of HCV care models among active PWID seen in opioid treatment programs and community clinics. Frequency, sharing and reuse of injecting equipment were assessed at baseline, end-of-treatment (EOT) and quarterly visits up to 60 weeks post-treatment. Generalized Estimating Equations logistic regression models with linear spline were used to compare trends in injecting behaviors during vs. post-treatment. Multivariable logistic regression models explored associations between injecting behaviors during treatment and lack of SVR. RESULTS: Among 501 participants, 27% were female, 35% were non-white, mean age was 44 (SD 11.5) years and nearly half (49%) were unhoused. At baseline, 41% reported receptive sharing of injecting equipment, declining to 16% at EOT visit. Receptive sharing of cookers, rinses, or needles/syringes during treatment was associated with a nearly 5-fold increase in not achieving SVR (adjusted odds ratio (aOR)=4.83; 95% CI: 2.26, 10.28) as was reuse of one's own needles/syringes (aOR=2.37; 95% CI: 1.11, 4.92). CONCLUSIONS: PWID in the HERO study adopted safer injecting behaviors during DAA treatment; receptive sharing of injecting equipment and reuse of one's own equipment during treatment were associated with not achieving cure.

A patient-centered comparative effectiveness research study of culturally appropriate options for diabetes self-management.

This project compared the effectiveness of two evidence-based models of culturally competent diabetes health promotion: The Diabetes Self-Management Support Empowerment Model (DSMS), and The Chronic Care Model (CCM). Our primary outcome was improvement in patient capacity for diabetes self-management as measured by the Diabetes Knowledge Questionnaire (DKQ) and the Patient Activation Measure (PAM). Our secondary outcome was patient success at diabetes self-management as measured by improvement in A1c, depression sores using the PHQ-9, and Body Mass Index (BMI). We also gathered data on the cultural competence of the program using the Consumer Assessment of Healthcare Providers and Systems Cultural Competence Set (CAHPS-CC). We compared patient outcomes in two existing sites in Albuquerque, New Mexico that serve a large population of Latino diabetes patients from low-income households. Participants were enrolled as dyads-a patient participant (n=226) and a social support participant (n=226). Outcomes over time and by program were analyzed using longitudinal linear mixed modeling, adjusted for patient participant demographic characteristics and other potential confounding covariates. Secondary outcomes were also adjusted for potential confounders. Interactions with both time and program helped to assess outcomes. This study did not find a difference between the two sites with respect to the primary outcome measures and only one of the three secondary outcomes showed differential results. The main difference between programs was that depression decreased more for CCM than for DSMS. An exploratory, subgroup analysis revealed that at CCM, patient participants with a very high A1c (>10) demonstrated a clinically meaningful decrease. However, given the higher cultural competence rating for the CCM, statistically significant improvement in depression, and the importance of social support to the patients, results suggest that a culturally and contextually situated diabetes self-management and education program design may deliver benefit for patients, especially for patients with higher A1c levels.

Screening for opioid use disorder and co-occurring depression and post-traumatic stress disorder in primary care in New Mexico.

BACKGROUND: Identifying patients in primary care services with opioid use disorder and co-occurring mental health disorders is critical to providing treatment. Objectives of this study were to (1) assess the feasibility of recruiting people to screen in-person for opioid use disorder and co-occurring mental health disorders (depression and/or post-traumatic stress disorder) in primary care clinic waiting rooms in preparation for a randomized controlled trial, and (2) compare results of detecting these disorders by universal in-person screening compared to electronic health record (EHR) diagnoses. METHODS: This cross-sectional feasibility and pilot study recruited participants from four primary care clinics, two rural and two urban, from three health care organizations in New Mexico. Inclusion criteria were adults (≥ 18 years), attending one of the four clinics as a patient, and who spoke English or Spanish. Exclusion criteria were people attending the clinic for a non-primary care visit (e.g., dental, prescription pick up, social support). The main outcomes and measures were (1) recruitment feasibility which was assessed by frequencies and proportions of people approached and consented for in-person screening, and (2) relative differences of detecting opioid use disorder and co-occurring mental health disorders in waiting rooms relative to aggregate EHR data from each clinic, measured by prevalence and prevalence ratios. RESULTS: Over two-weeks, 1478 potential participants were approached and 1145 were consented and screened (77.5% of patients approached). Probable opioid use disorder and co-occurring mental health disorders were identified in 2.4% of those screened compared to 0.8% in EHR. Similarly, universal screening relative to EHR identified higher proportions of probable opioid use disorder (4.5% vs. 3.4%), depression (17.5% vs. 12.7%) and post-traumatic stress disorder (19.0% vs. 3.6%). CONCLUSIONS: Universal screening for opioid use disorder, depression, and post-traumatic stress disorder was feasible, and identified three times as many patients with these co-occurring disorders compared to EHR. Higher proportions of each condition were also identified, especially post-traumatic stress disorder. Results support that there are likely gaps in identification of these disorders in primary care services and demonstrate the need to better address the persistent public health problem of these co-occurring disorders.

Associations between depression and diabetes among Latinx patients from low-income households in New Mexico.

Depression and diabetes are co-occurring epidemics. This article explores the association between depression and diabetes in a cohort of Latinx patients with diabetes from low-income households. Data were gathered in Albuquerque, New Mexico (U.S.) between 2016 and 2020 as part of a patient-engaged comparative effectiveness trial comparing two culturally appropriate diabetes self-management programs-the Chronic Care Model (CCM) and the standard of care, Diabetes Self-Management Support Empowerment Model (DSMS). We proposed that the program most culturally and contextually situated in the life of the patient would have the greatest impact on diabetes self-management. Participants were enrolled as dyads-226 Latinx diabetes patient participants (PPs) from low-income households and 226 social support participants (SSPs). Data gathered at baseline, 3, 6, and 12 months included a measure of depression and A1c testing. Outcomes between programs were analyzed using longitudinal linear mixed modeling, adjusted for patient demographic characteristics and other potential confounding covariates. Patient A1c had an initial slight decrease at 3 months in both programs. At CCM, patients with a very high A1c (greater than 10%) demonstrated a clinically meaningful decrease in A1c over time. Patients at CCM experienced a large initial decrease in depression and continued to decrease throughout the study, while patients at DSMS showed a slight initial decrease through 6 months, but depression increased again by 12 months, nearly rebounding to baseline levels. A subgroup analysis revealed that a higher baseline A1c was associated with higher depression, and patients with higher A1c achieved greater reductions in depression at CCM than at DSMS. CCM scored higher on Consumer Assessment of Healthcare Providers and Systems cultural competence (CAHPS-CC). Interpretation of results suggests that the more culturally, contextually situated program, CCM, had better outcomes. This study demonstrates that culturally and contextually situating a diabetes intervention can deliver improved benefits for Latinx patients.

Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial.

BACKGROUND: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use. METHODS: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640. FINDINGS: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group). INTERPRETATION: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support. FUNDING: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.

The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder.

BACKGROUND: People with opioid use disorder experience high burden of disease from medical comorbidities and are increasingly hospitalized with medical complications. Medications for opioid use disorder are an effective, life-saving treatment, but patients with an opioid use disorder admitted to the hospital seldom initiate medication for their disorder while in the hospital, nor are they linked with outpatient treatment after discharge. The inpatient stay, when patients may be more receptive to improving their health and reducing substance use, offers an opportunity to discuss opioid use disorder and facilitate medication initiation and linkage to treatment after discharge. An addiction-focus consultative team that uses evidence-based tools and resources could address barriers, such as the need for the primary medical team to focus on the primary health problem and lack of time and expertise, that prevent primary medical teams from addressing substance use. METHODS: This study is a pragmatic randomized controlled trial that will evaluate whether a consultative team, called the Substance Use Treatment and Recovery Team (START), increases initiation of any US Food and Drug Administration approved medication for opioid use disorder (buprenorphine, methadone, naltrexone) during the hospital stay and increases linkage to treatment after discharge compared to patients receiving usual care. The study is being conducted at three geographically distinct academic hospitals. Patients are randomly assigned within each hospital to receive the START intervention or usual care. Primary study outcomes are initiation of medication for opioid use disorder in the hospital and linkage to medication or other opioid use disorder treatment after discharge. Outcomes are assessed through participant interviews at baseline and 1 month after discharge and data from hospital and outpatient medical records. DISCUSSION: The START intervention offers a compelling model to improve care for hospitalized patients with opioid use disorder. The study could also advance translational science by identifying an effective and generalizable approach to treating not only opioid use disorder, but also other substance use disorders and behavioral health conditions. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05086796, Registered on 10/21/2021. https://www. CLINICALTRIALS: gov/ct2/results?recrs=ab&cond=&term=NCT05086796&cntry=&state=&city=&dist = .

A Study of a Culturally and Contextually Situated Multimedia Approach to Recruit a Hard-to-Reach Spanish-Speaking Population for a Randomized Control Trial (RCT).

Study designs involving randomization can be difficult to communicate to participants, especially those with low literacy. The literature on strategies to explain research concepts is limited, especially for non-English speakers. We measured the effectiveness of a culturally and contextually situated multimedia approach to recruit a cohort of 60 female Mexican immigrants (FMI) to a randomized control trial (RCT) to reduce social isolation and depression. This strategy was designed to explain the concept of randomization, explain what participating in the research study entailed, and ensure informed consent. Potential participants viewed a presentation explaining the study and a video including animation with voice-over explaining the concept of randomization. We administered a pre/post survey. Respondents (N = 59) reported an increase in their understanding of randomization, intention to enroll, and attitude towards participating in research. We conclude that a culturally and contextually situated multimedia approach is an effective model when recruiting underrepresented populations with low literacy for RCTs.

Prevalence of marijuana use in pregnant women with concurrent opioid use disorder or alcohol use in pregnancy.

BACKGROUND: A quarter of pregnant women use alcohol, 6.5/1000 deliveries are affected by opioid use disorder (OUD), and the prevalence of cannabis use in pregnant women is increasing. However, marijuana co-exposure in polysubstance-using women is not well described. METHODS: The well-characterized ENRICH-1 cohort (n = 251), which focused on the effects of two primary exposures of interest-opioids and alcohol, was used to (1) estimate the prevalence/frequency of marijuana use in those with OUD and/or alcohol use, and (2) examined correlates of marijuana use. Participants were classified into an OUD group (n = 125), Alcohol group (n = 69), and concurrent OUD and Alcohol (OUD + Alcohol) group (n = 57). Self-report and biomarkers ascertained substance use. Multivariable logistic regression identified correlates of marijuana use. RESULTS: The prevalence of any marijuana use in pregnancy was 43.2%, 52.6%, and 46.4% in the OUD, OUD + Alcohol, and Alcohol groups, respectively. Correspondingly, weekly or daily use was reported by 19.4%, 21.0%, and 24.6% of participants. In the OUD and OUD + Alcohol groups, the proportion of women using marijuana was significantly higher in those taking buprenorphine (45.8% and 58.3%, respectively) compared to women using methadone (37.5% and 42.9%, respectively). Mean maternal age was lower in women who used marijuana in all three groups compared to non-marijuana users. Independent correlates of marijuana use (controlling for group, race/ethnicity, education, and smoking) were maternal age (adjusted Odds Ratio (aOR) per 5-year increment 0.61; (95% CI 0.47, 0.79)), and polysubstance use (aOR 2.02; 95% CI 1.11, 3.67). There was a significant interaction between partnership status and group: among women who were not in a partnership, those in the OUD and OUD + Alcohol groups had lower odds of marijuana use relative to the Alcohol group. For women in the Alcohol group, partnered women had lower odds of marijuana use than un-partnered women (aOR 0.12; 95% CI: 0.02, 0.68). CONCLUSIONS: Results indicate a relatively high prevalence and frequency of marijuana use in pregnant women being treated for OUD and/or women consuming alcohol while pregnant. These results highlight the need for ongoing risk reduction strategies addressing marijuana use for pregnant women receiving OUD treatment and those with alcohol exposure.

Design of CLARO (Collaboration Leading to Addiction Treatment and Recovery from other Stresses): A randomized trial of collaborative care for opioid use disorder and co-occurring depression and/or posttraumatic stress disorder.

INTRODUCTION: Opioid use disorder (OUD) co-occurring with depression and/or posttraumatic stress disorder (PTSD) is common and, if untreated, may lead to devastating consequences. Despite the availability of evidence-based treatments for these disorders, receipt of treatment is low. Even when treatment is provided, quality is variable. Primary care is an important and underutilized setting for treating co-occurring disorders (COD) because OUD, depression and PTSD are frequently co-morbid with medical conditions and most people visit a primary care provider at least once a year. With rising rates of OUD and opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. METHODS: CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) is a multi-site, randomized pragmatic trial of collaborative care (CC) for co-occurring disorders in 13 rural and urban primary care clinics in New Mexico to improve care for patients with OUD and co-occurring depression and/or PTSD. CC, a service delivery approach that uses multi-faceted interventions, has not been tested with COD. We will enroll and randomize 900 patients to either CC adapted for COD (CC-COD) or enhanced usual care (EUC) and will collect patient data at baseline, 3-, and 6-month follow-up. Our primary outcomes are medications for OUD (MOUD) access, MOUD continuity of care, depression symptoms, and PTSD symptoms. DISCUSSION: Although CC is effective for improving outcomes in primary care among patients with mental health conditions, it has not been tested for COD. This article describes the CLARO CC-COD intervention and clinical trial.

A randomized control trial to test a peer support group approach for reducing social isolation and depression among female Mexican immigrants.

BACKGROUND: Female Mexican Immigrants (FMIs) experience high rates of depression compared with other populations. For this population, depression is often exacerbated by social isolation associated with the experience of immigration. Aim 1. To measure whether a culturally situated peer group intervention will reduce depression and stress associated with the experience of immigration. Aim 2. To test whether an intervention using a "women's funds of knowledge" approach results in improved resilience, knowledge and empowerment. Aim 3. To investigate whether a culturally situated peer group intervention using a women's funds of knowledge approach can give participants a sense and experience of social and physical connection ("emplacement") that is lost in the process of immigration. METHODS: This mixed-methods study will implement "Tertulias" ("conversational gatherings" in Spanish), a peer support group intervention designed to improve health outcomes for FMI participants in Albuquerque, New Mexico. We will document results of the intervention on our primary hypotheses of a decrease in depression, and increases in resilience and social support, as well as on our secondary hypotheses of decreased stress (including testing of hair cortisol as a biomarker for chronic stress), and an increase in social connectedness and positive assessment of knowledge and empowerment. DISCUSSION: This project will address mental health disparities in an underserved population that experiences high rates of social isolation. Successful completion of this project will demonstrate that health challenges that may appear too complex and too hard to address can be using a multi-level, holistic approach. Our use of hair samples to test for the 3-month average levels of systemic cortisol will contribute to the literature on an emerging biomarker for analyzing chronic stress. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on 2/3/20, Identifier # NCT04254198 .

Traveling for rights: Abortion trends in New Mexico after passage of restrictive Texas legislation.

OBJECTIVES: To determine the proportion of abortions provided to patients from Texas in New Mexico before and after the 2013 enactment of Texas House Bill 2 (HB2), an omnibus bill of abortion restrictions, and to compare the gestational ages at which Texans presented for abortion in New Mexico before and after HB2. STUDY DESIGN: We conducted a chart review of Texas and New Mexico patients obtaining an abortion in New Mexico abortion clinics before HB 2 was signed and implemented (time period 1: January 1, 2012 to December 31, 2012) and after HB 2 went into effect (time period 2: May 1, 2014 to April 30, 2015). We used random sampling of corresponding 7-day periods (by week number during the one-year sample) to obtain data until we reached the desired sample of at least 300 patients. We compared proportions of individuals from Texas obtaining abortions and the gestational age at which they presented in the two time periods. RESULTS: We abstracted data from 350 and 300 Texas and New Mexico patients, respectively. The proportion of procedures provided to women from Texas increased from 10 (3%) pre-HB2 to 43 (14%) post-HB2 (p < 0.0001). The proportion of procedures in Texas patients at 13 to ≤24 weeks increased from 1 of 29 (3%) pre-HB2 to 10 of 38 (26%) post-HB2 (p = 0.012). CONCLUSION: The proportion of Texans scheduling abortions in New Mexico within the first 24 weeks of gestation increased after passage of HB2. Restrictive legislation may force more people to travel across state lines to obtain abortion care. IMPLICATIONS: Patients residing in Texas and seeking abortion care in Texas experienced barriers to abortion care, likely related to restrictions imposed by HB2.

Improved breastfeeding duration with Baby Friendly Hospital Initiative implementation in a diverse and underserved population.

BACKGROUND: Few studies have evaluated the impact of Baby Friendly Hospital Initiative (BFHI) implementation on underserved populations in the United States. We undertook this study in New Mexico, a large southwestern state with a diverse population and limited health care access. METHODS: A quasi-experimental, retrospective cohort design was used to compare short-term breastfeeding duration between a pre-BFHI and a post-BFHI cohort. Among the post-BFHI cohort, logistic regression models were fitted to predict short-term breastfeeding duration from both individual and cumulative exposure to inpatient maternity care practices (Steps 4 to 9). RESULTS: Implementation of the BFHI and cumulative exposure to the Ten Steps increased short-term duration of any breastfeeding and exclusive breastfeeding at 2-6 weeks postpartum. Exposure to all six of the inpatient Ten Steps increased the odds of any breastfeeding by 34 times and exclusive breastfeeding by 24 times. Exposure to Step 9 ("Give no pacifiers or artificial nipples") uniquely increased the likelihood of any breastfeeding at 2-6 weeks postpartum by 5.7 times, whereas Step 6 ("Give infants no food or drink other than breastmilk") increased the rate of exclusive breastfeeding by 4.4 times at 2-6 weeks postpartum. CONCLUSION: These findings demonstrate that the Baby Friendly Hospital Initiative can have a positive impact on breastfeeding among underserved populations.