Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services.

BACKGROUND: People who inject drugs (PWID) remain a high priority population under the federal Ending the HIV Epidemic initiative with 11% of new HIV infections attributable to injection drug use. There is a critical need for innovative, efficacious, scalable, and community-driven models of healthcare in non-stigmatizing settings for PWID. We seek to test a Comprehensive-TeleHarm Reduction (C-THR) intervention for HIV prevention services delivered via a syringe services program (SSP). METHODS: The CHARIOT trial is a hybrid type I effectiveness-implementation study using a parallel two-arm randomized controlled trial design. Participants (i.e., PWID; n = 350) will be recruited from a syringe services program (SSP) in Miami, Florida. Participants will be randomized to receive either C-THR or non-SSP clinic referral and patient navigation. The objectives are: (1) to determine if the C-THR intervention increases engagement in HIV prevention (i.e., HIV pre-exposure prophylaxis; PrEP or medications for opioid use disorder; MOUD) compared to non-SSP clinic referral and patient navigation, (2) to examine the long-term effectiveness and cost-effectiveness of the C-THR intervention, and (3) to assess the barriers and facilitators to implementation and sustainment of the C-THR intervention. The co-primary outcomes are PrEP or MOUD engagement across follow-up at 3, 6, 9 and 12 months. For PrEP, engagement is confirmed by tenofovir on dried blood spot or cabotegravir injection within the previous 8 weeks. For MOUD, engagement is defined as screening positive for norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine injection within the previous 4 weeks. Secondary outcomes include PrEP adherence, engagement in HCV treatment and sustained virologic response, and treatment of sexually transmitted infections. The short and long term cost-effectiveness analyses and mixed-methods implementation evaluation will provide compelling data on the sustainability and possible impact of C-THR on comprehensive HIV prevention delivered via SSPs. DISCUSSION: The CHARIOT trial will be the first to our knowledge to test the efficacy of an innovative, peer-led telehealth intervention with PWID at risk for HIV delivered via an SSP. This innovative healthcare model seeks to transform the way PWID access care by bypassing the traditional healthcare system, reducing multi-level barriers to care, and meeting PWID where they are. TRIAL REGISTRATION: ClinicalTrials.gov NCT05897099. Trial registry name: Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT). Registration date: 06/12/2023.

Phosphorylation of the Myogenic Factor Myocyte Enhancer Factor-2 Impacts Myogenesis In Vivo.

Activity of the myogenic regulatory protein myocyte enhancer factor-2 (MEF2) is modulated by post-translational modification. We investigated the in vivo phosphorylation of Drosophila MEF2, and identified serine 98 (S98) as a phosphorylated residue. Phospho-mimetic (S98E) and phospho-null (S98A) isoforms of MEF2 did not differ from wild-type in their activity in vitro, so we used CRISPR/Cas9 to generate an S98A allele of the endogenous gene. In mutant larvae we observed phenotypes characteristic of reduced MEF2 function, including reduced body wall muscle size and reduced expression of myofibrillar protein genes; conversely,S98A homozygotes showed enhanced MEF2 function through muscle differentiation within the adult myoblasts associated with the wing imaginal disc. In adults, S98A homozygotes were viable with normal mobility, yet showed patterning defects in muscles that were enhanced when the S98A allele was combined with a Mef2 null allele. Overall our data indicate that blocking MEF2 S98 phosphorylation in myoblasts enhances its myogenic capability, whereas blocking S98 phosphorylation in differentiating muscles attenuates MEF2 function. Our studies are among the first to assess the functional significance of MEF2 phosphorylation sites in the intact animal, and suggest that the same modification can have profoundly different effects upon MEF2 function depending upon the developmental context.

Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs.

BACKGROUND: The resurgence of HIV outbreaks and rising prevalence among people who inject drugs (PWID) remain exigent obstacles to Ending the HIV Epidemic in the USA. Adapting a low threshold, comprehensive treatment model for PWID with HIV can leverage syringe services programs (SSPs) to increase availability and accessibility of antiretrovirals (ART), medications for opioid use disorder (MOUD), and hepatitis C cure. We developed Tele-Harm Reduction, a telehealth-enhanced, harm reduction intervention delivered within an SSP venue. METHODS: The T-SHARP trial is an open-label, multi-site, randomized controlled superiority trial with two parallel treatment arms. Participants (n=240) recruited from SSPs in Miami, Ft. Lauderdale, and Tampa, Florida, who are PWID with uncontrolled HIV (i.e., HIV RNA>200) will be randomized to Tele-Harm Reduction or off-site linkage to HIV care. The primary objective is to compare the efficacy of Tele-Harm Reduction for initiation of ART at SSPs vs. off-site linkage to an HIV clinic with respect to viral suppression across follow-up (suppression at 3, 6, and 12 months post randomization). Participants with HIV RNA<200 copies/ml will be considered virally suppressed. The primary trial outcome is time-averaged HIV viral suppression (HIV RNA <200 copies/ml) over 3-, 6-, and 12-month follow-up. Secondary outcomes include initiation of MOUD measured by urine drug screen and HCV cure, defined as achieving 12-week sustained virologic response (negative HCV RNA at 12 weeks post treatment completion). A cost-effectiveness analysis will be performed. DISCUSSION: The T-SHARP Trial will be the first to our knowledge to test the efficacy of an innovative telehealth intervention with PWID with uncontrolled HIV delivered via an SSP to support HIV viral suppression. Tele-Harm Reduction is further facilitated by a peer to support adherence and bridge the digital divide. This innovative, flipped healthcare model sets aside the traditional healthcare system, reduces multi-level barriers to care, and meets PWID where they are. The T-SHARP trial is a pragmatic clinical trial that seeks to transform the way that PWID access HIV care and improve HIV clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05208697. Trial registry name: Tele-Harm Reduction. Registration date: January 26, 2022.

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.

Effects of Pubertal Status and Inflammation on the Use of Ferritin to Define Iron Deficiency in Children With Overweight or Obesity.

BACKGROUND AND AIMS: A worldwide increase in childhood overweight (OW) and obesity (OB) has been reported. OB is an inflammatory state which affects iron metabolism and the sensibility of the tests to detect iron deficiency (ID). Our aim was to evaluate the adequacy of current ferritin cut-offs to define ID in children with OW/OB. METHODS: This cross-sectional study included 152 children (54% girls) aged (median [Q1-Q3]) 11 (8-13) years with OW/OB. Complete blood count and iron metabolism were evaluated. Low ferritin, transferrin saturation (TSat), and anemia were defined by age- and sex-specific cut-offs recommended by National Guidelines. Iron intake was assessed in a subgroup (n = 80) by a 24-hour dietary recall. Analyses were made according to pubertal development and ferritin tertiles. RESULTS: The overall prevalence of low ferritin, TSat, and anemia was 2.6%, 23.8%, and 5.2%, respectively. Among pre-pubertal children (n = 87), the frequency of low TSat rose across ferritin tertiles (P < .05), whereas it decreased among pubertal children (n = 65; P < .005). Cases of anemia among pre-pubertal children were found in the highest ferritin tertile, whereas 4/6 anemia cases in pubertal children were found in the lowest ferritin tertile (<39 µg/L). Pubertal children within the lowest ferritin tertile + low TSat (n = 11) showed lower hemoglobin (-9%; P < .005) and hematocrit (-8%, P < .01) than those in the same tertile + normal TSat (n = 16). The overall prevalence of children with ferritin < 39 µg/L + low TSat was 9.2%. CONCLUSIONS: Higher ferritin cut-off values are required to define ID in children with OW/OB. Such cut-off remains to be validated in larger, multi-ethnic cohorts of children with OW/OB.

Motivational enhancement treatment in outpatient addiction centers: A multisite randomized trial / Intervención de incremento motivacional en centros ambulatorios para las adicciones: un ensayo aleatorizado multicéntrico

Background/Objectives: Motivational Enhancement Treatment in Spanish (METS) is a brief intervention aimed at resolving patient ambivalence towards behavior change that has demonstrated efficacy in substance use disorder treatment to reduce use and increase treatment engagement in different populations. In order to have evidence for its implementation in Mexico, a multi-site, randomized, two-arm, controlled clinical trial was conducted at three outpatient addiction treatment centers in the country to compare the effect of METS with Counseling as Usual (CAU). Method: One hundred and twenty patients were randomized to receive three sessions of METS (n = 54) or CAU (n = 66) during the first four weeks of treatment and were assessed during the following 12 weeks. Primary outcome measures were self-reported days of substance use and of treatment services utilization, which were tested using Generalized Estimating Equations. Results: Results associated both conditions with significant changes in substance use over, whereas there were no differences between conditions in substance use or in service utilization. Conclusions: Findings do not support the hypothesis that METS is more effective than CAU, but suggest that brief interventions at treatment initiation may improve patient outcomes (AU)

Antecedentes/Objetivos: La Intervención de Incremento Motivacional (METS) es una intervención breve para resolver la ambivalencia del paciente con respecto a su comportamiento y ha demostrado eficacia en distintas poblaciones para reducir el consumo de sustancias e incrementar la asistencia al tratamiento en adicciones. Con el objetivo de generar evidencia para su implementación en México, se desarrolló un ensayo clínico controlado, multisede, aleatorizado, de dos brazos en tres centros de tratamiento ambulatorio para adicciones, para comparar el efecto de METS con el del tratamiento usual (CAU). Método: Ciento veinte pacientes fueron aleatorizados a tres sesiones de METS (n = 54) o CAU (n = 66) durante las primeras cuatro semanas de tratamiento y evaluados durante las siguientes doce. Se midieron resultados mediante autoinforme de días con consumo de sustancias y días de utilización de servicios, los cuales fueron analizados mediante ecuaciones de estimación generalizadas. Resultados: Los resultados asociaron ambas condiciones a cambios significativos en uso de sustancias a lo largo del tiempo, pero no demostraron diferencias entre condiciones en el uso de sustancias o en la utilización de servicios. Conclusiones: Los hallazgos contradicen la hipótesis de superioridad de METS sobre CAU, pero sugieren que las intervenciones breves al inicio del tratamiento pudieran mejorar la respuesta del paciente (AU)

Motivational enhancement treatment in outpatient addiction centers: A multisite randomized trial.

BACKGROUND/OBJECTIVES: Motivational Enhancement Treatment in Spanish (METS) is a brief intervention aimed at resolving patient ambivalence towards behavior change that has demonstrated efficacy in substance use disorder treatment to reduce use and increase treatment engagement in different populations. In order to have evidence for its implementation in Mexico, a multi-site, randomized, two-arm, controlled clinical trial was conducted at three outpatient addiction treatment centers in the country to compare the effect of METS with Counseling as Usual (CAU). METHOD: One hundred and twenty patients were randomized to receive three sessions of METS (n = 54) or CAU (n = 66) during the first four weeks of treatment and were assessed during the following 12 weeks. Primary outcome measures were self-reported days of substance use and of treatment services utilization, which were tested using Generalized Estimating Equations. RESULTS: Results associated both conditions with significant changes in substance use over, whereas there were no differences between conditions in substance use or in service utilization. CONCLUSIONS: Findings do not support the hypothesis that METS is more effective than CAU, but suggest that brief interventions at treatment initiation may improve patient outcomes.

Antecedentes/Objetivos: La Intervención de Incremento Motivacional (METS) es una intervención breve para resolver la ambivalencia del paciente con respecto a su comportamiento y ha demostrado eficacia en distintas poblaciones para reducir el consumo de sustancias e incrementar la asistencia al tratamiento en adicciones. Con el objetivo de generar evidencia para su implementación en México, se desarrolló un ensayo clínico controlado, multi-sede, aleatorizado, de dos brazos en tres centros de tratamiento ambulatorio para adicciones, para comparar el efecto de METS con el del tratamiento usual (CAU). Método: Ciento veinte pacientes fueron aleatorizados a tres sesiones de METS (n = 54) o CAU (n = 66) durante las primeras cuatro semanas de tratamiento y evaluados durante las siguientes doce. Se midieron resultados mediante autoinforme de días con consumo de sustancias y días de utilización de servicios, los cuales fueron analizados mediante ecuaciones de estimación generalizadas. Resultados: Los resultados asociaron ambas condiciones a cambios significativos en uso de sustancias a lo largo del tiempo, pero no demostraron diferencias entre condiciones en el uso de sustancias o en la utilización de servicios. Conclusiones: Los hallazgos contradicen la hipótesis de superioridad de METS sobre CAU, pero sugieren que las intervenciones breves al inicio del tratamiento pudieran mejorar la respuesta del paciente.

Readiness and barriers to adopt evidence-based practices for substance abuse treatment in Mexico / Disponibilidad y barreras a la adopción de prácticas basadas en la evidencia para el tratamiento del uso de sustancias en México

ABSTRACT: Introduction: Evidence shows a lag in adoption of evidence-based practices (EBPs) for substance abuse treatment and supports the need for studying the factors involved in this worldwide problem. Objective: This study aimed to assess the readiness and barriers to adopt EBPs for substance abuse in a sample of outpatient treatment centers of a newly created Mexican Clinical Trials Network. Method: An online survey was administered to directors (n = 8) and clinicians (n = 40) from seven outpatient treatment centers in Mexico. Questions were obtained from two surveys that had been implemented in the US to assess the same objectives. Results: Respondents reported being more ready to adopt Cognitive Behavioral Therapy (CBT, 83.3%) and Motivational Enhancement Therapy (MET, 79.1%), compared to 12 step facilitation (58.3%), couples therapy (56.2%), Brief Strategic Family Therapy (BSFT, 66.6%), and motivational incentives (60.4%). Directors had lower mean resistance to EBPs (11.8 vs. 17.4; p = 0.01) than clinicians. The biggest barriers identified by directors to EBP adoption were not having enough clinical staff, being unable to afford well-trained staff, not enough psychiatric and medical support. Discussion and conclusion: CBT and MET emerged as the most frequently used evidence based practices in the sites that are part of the Mexican Clinical Trials Network. Staff positive attitudes towards EBPs are critical for adoption.

RESUMEN: Introducción: La literatura demuestra una demora en la adopción de las practicas basadas en la evidencia (PBEs) para el tratamiento del abuso de sustancias y apoya la necesidad de estudiar los factores involucrados en este problema mundial. Objetivo: Este estudio evaluó la disponiblildad y las barreras de la adopción de PBE para el abuso de sustancias en una muestra de centros pertenencientes a la nueva Red Mexicana de Ensayos Clinicos. Método: Se administró una encuesta online a directores (n = 8) y a clinicos (n = 40) de siete centros de tratamiento ambulatorio para el tratamiento de las adicciones en México. Las preguntas se obtuvieron de dos encuestas que se administraron en los Estados Unidos con los mismos objetivos. Resultados: Los encuestados reportaron estar más dispuestos a la adopción de la Terapia Cognitivo Conductual (CBT,83.3%) y Terapia de Incremento Motivacional (MET, 79.1%),comparado con la facilitación de los 12 pasos (58.3%),terapia de pareja (56.2%), Terapia Familiar Breve y Estratégica (BSFT, 66.6%),e incentivos para la motivación (60.4%). Los directores tuvieron menor promedio de Resistencia a las PBEs (11.8 vs. 17.4; p = 0.01) que los clinicos. Las principales barreras identificadas por los directores fueron no tener suficiente personal clínico, no poder costear personal altamente entrenado, apoyo psiquiátrico y médico insuficiente. Discusión y conclusión: La CBT y la MET emergieron como las PBEs usadas con mayor frecuencia en centros que son parte de la Red Mexicana de Ensayos Clínicos. Las actitudes positivas del personal hacia las PBEs son críticas para la adopción.

Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

BACKGROUND: Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. METHODS/DESIGN: Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. DISCUSSION: The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. TRIAL REGISTRATION: MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador.

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico / Transferencia de tecnología para la implantación de una red de investigaciones clínicas sobre el tratamiento de la drogadicción y los problemas de salud mental en México

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011–2013. The Florida Node Alliance shared the “know how” for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Los países de ingresos bajos o medios (PIBM) carecen de una infraestructura de investigación y de la capacidad para llevar a cabo investigaciones clínicas rigurosas sobre la eficacia del tratamiento de la drogadicción y los problemas de salud mental que orienten la práctica clínica. Se estableció una asociación entre la Florida Node Alliance de la National Drug Abuse Treatment Clinical Trials Network de los Estados Unidos y el Instituto Nacional de Psiquiatría de México con objeto de mejorar la práctica en materia de tratamiento de la drogadicción en México. La finalidad de esta asociación fue la de crear una red nacional mexicana de investigaciones clínicas constituida por investigadores y proveedores de tratamiento de la drogadicción capaces de ejecutar ensayos clínicos aleatorizados de eficacia en entornos comunitarios. Se implantó un modelo de transferencia de tecnologías. La Florida Node Alliance compartió el el conocimiento y la experiencia para la creación de la infraestructura de investigación con objeto de ejecutar investigaciones clínicas aleatorizadas en programas comunitarios, por medio de módulos de capacitación común y específica, entrenamiento en funciones específicas, emparejamientos, modelado, vigilancia y retroalimentación. El proceso de transferencia de tecnología fue de tipo bidireccional en cuanto se basó en la retroalimentación sobre la viabilidad y la adecuación cultural para el contexto en el que se llevaron a cabo las prácticas. El Instituto, a su vez, lideró la iniciativa para crear la red nacional de investigadores y profesionales de México y llevar a cabo el primer ensayo. Un modelo colaborativo de transferencia de tecnología resultó útil para la creación de una red mexicana de investigadores y proveedores de tratamiento capaz de cambiar las prácticas nacionales de investigación y tratamiento en materia de drogadicción. Se exponen las consideraciones clave para la transferencia transnacional de tecnología.

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico / Transferencia de tecnología para la implantación de una red de investigaciones clínicas sobre el tratamiento de la drogadicción y los problemas de salud mental en México

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Los países de ingresos bajos o medios (PIBM) carecen de una infraestructura de investigación y de la capacidad para llevar a cabo investigaciones clínicas rigurosas sobre la eficacia del tratamiento de la drogadicción y los problemas de salud mental que orienten la práctica clínica. Se estableció una asociación entre la Florida Node Alliance de la National Drug Abuse Treatment Clinical Trials Network de los Estados Unidos y el Instituto Nacional de Psiquiatría de México con objeto de mejorar la práctica en materia de tratamiento de la drogadicción en México. La finalidad de esta asociación fue la de crear una red nacional mexicana de investigaciones clínicas constituida por investigadores y proveedores de tratamiento de la drogadicción capaces de ejecutar ensayos clínicos aleatorizados de eficacia en entornos comunitarios. Se implantó un modelo de transferencia de tecnologías. La Florida Node Alliance compartió el el conocimiento y la experiencia para la creación de la infraestructura de investigación con objeto de ejecutar investigaciones clínicas aleatorizadas en programas comunitarios, por medio de módulos de capacitación común y específica, entrenamiento en funciones específicas, emparejamientos, modelado, vigilancia y retroalimentación. El proceso de transferencia de tecnología fue de tipo bidireccional en cuanto se basó en la retroalimentación sobre la viabilidad y la adecuación cultural para el contexto en el que se llevaron a cabo las prácticas. El Instituto, a su vez, lideró la iniciativa para crear la red nacional de investigadores y profesionales de México y llevar a cabo el primer ensayo. Un modelo colaborativo de transferencia de tecnología resultó útil para la creación de una red mexicana de investigadores y proveedores de tratamiento capaz de cambiar las prácticas nacionales de investigación y tratamiento en materia de drogadicción. Se exponen las consideraciones clave para la transferencia transnacional de tecnología.

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico.

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Characteristics of a treatment-seeking population in outpatient addiction treatment centers in Mexico.

BACKGROUND: Baseline patients' characteristics are critical for treatment planning, as these can be moderators of treatment effects. In Mexico, information on treatment seekers with substance use disorders is scarce and limited to demographic characteristics. OBJECTIVE: This paper presents and analyses demographic characteristics, substance use related problems, clinical features, and addiction severity in a sample of treatment seekers from the first multi-site randomized clinical trial implemented in the Mexican Clinical Trials Network on Addiction and Mental Health. METHODS: A total of 120 participants were assessed prior randomization. Chi square or F-tests were used to compare sites across variables. Spearman correlation was used to associate negative consequences of substance use and motivation to change. RESULTS: The majority of participants were men, and the most prevalent substances reported were alcohol, marijuana, and cocaine. Participants were predominantly on the contemplation or action stage of change, and this was correlated with the perception of the negative consequences associated with substance use. Participants reported a high prevalence of substance use related problems. CONCLUSIONS: Substance use related problems, clinical features, and addiction severity reported by treatment seekers are important characteristics to take into account when planning treatment as they facilitate tailoring treatment to meet patients' needs.

Transporting clinical research to community settings: designing and conducting a multisite trial of brief strategic family therapy.

This paper describes the development and implementation of a trial of Brief Strategic Family Therapy (BSFT), an evidence-based drug intervention for adolescents, in eight community substance abuse treatment programs. Researchers and treatment programs collaborated closely to identify and overcome challenges, many of them related to achieving results that were both scientifically rigorous and applicable to the widest possible variety of adolescent substance abuse treatment programs. To meet these challenges, the collaborative team drew on lessons and practices from efficacy, effectiveness, and implementation research.

Use of bioelectrical impedance analysis to predict energy expenditure of hospitalized patients receiving nutrition support.

BACKGROUND: The energy requirement of a patient receiving nutrition support is typically estimated by calculating the basal energy expenditure (BEE) using the Harris-Benedict equations and multiplying by stress and activity factors. Because fat-free mass (FFM) and fat mass (FM) are important determinants of BEE, we hypothesized that body composition estimates derived from bioelectrical impedance analysis (BIA) could be used to develop predictive equations for resting energy expenditure (REE) that were more accurate than those calculated using the Harris-Benedict equations. METHODS: Seventy-six adults referred to the nutrition support service were studied. REE was measured by indirect calorimetry, and single-frequency BIA was used to estimate FFM and FM. Using the first 20 male and 20 female patients, predictive equations for REE were developed by multiple regression analysis, using BIA-derived body composition values, age, and gender. The next 36 patients were used to compare the accuracy of these equations with the Harris-Benedict equations in estimating REE. RESULTS: Using BLA-derived body composition values, gender, and age, predictive equations were developed for REE that explained approximately 65% of the variance. Inclusion of other BIA or anthropometric parameters did not improve the equations. When compared with the Harris-Benedict equations, the equations developed in this study were significantly more accurate, providing an REE estimate that was closer to the measured value in about 75% of patients. CONCLUSIONS: These results indicate that BLA-derived body composition estimates may be used to more accurately predict the energy requirements of patients receiving nutrition support than calculations based on the Harris-Benedict equations.

Evaluation of stress factors and body weight adjustments currently used to estimate energy expenditure in hospitalized patients.

BACKGROUND: The purpose of this study was to critically examine current approaches for estimating energy expenditure and requirements of hospitalized patients requiring nutrition support. METHODS: All indirect calorimetry tests performed by our adult nutrition support service from 1991 to 2000 were reviewed. Stress factors were calculated as the measured energy expenditure divided by the predicted energy expenditure using the Harris-Benedict equation. Various methods for adjusting the body weights of obese subjects for use in the Harris-Benedict equation were evaluated. RESULTS: The average stress factor for these hospitalized patients was 1.25, and there were no differences in the stress factors between men and women. For obese subjects, using an adjusted body weight equal to ideal body weight plus 50% of the difference between ideal and actual body weight in the Harris-Benedict equation gave stress factors comparable with normal weight subjects. For underweight subjects, using the actual rather than ideal body weight gave stress factors that were most similar to normal weight patients. Disease-specific stress factors were calculated and compared with literature values. Mechanical ventilation, recent feeding, fever, and restlessness during the indirect calorimetry measurement increased the measured energy expenditure. CONCLUSIONS: Our findings provide nutrition support services with updated information on disease-specific stress factors that can be used for estimating energy expenditure in hospitalized patients. An adjusted body weight equal to ideal body weight plus 50% of the excess body weight should be used for estimating the energy requirements of obese patients requiring nutrition support.