Boston University - Clinical & Translational Science Institute

Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months.

Type: Interventional

Start Date: Feb 2023

open study

This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition. Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.

Type: Interventional

Start Date: Mar 2023

open study

The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers. The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.

Type: Interventional

Start Date: Oct 2022

open study

There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problems. This study is to learn more about the effectiveness and safety of CBD in the treatment of psychiatric problems in adults with ASD. The study will last 14 weeks total, during which six weeks participants will receive a pill containing CBD, two weeks where participants will receive no drug/placebo, and six weeks where participants will receive the placebo, an inactive pill. As part of the study, participants will have regular visits and be asked questions about anxiety, challenging behaviors, daily functioning, cognition, and physical symptoms, on standard assessments.

Type: Interventional

Start Date: Apr 2023

open study

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Type: Interventional

Start Date: Aug 2021

open study

Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging. The primary study objective of MOCHA is to develop an accurate and reliable assessment algorithm for determining neurologic prognosis in patients initially unconscious (no eye opening, GCS-M<6 and not following commands) post-cardiac arrest, using multiple prognostic modalities at standardized time points.

Type: Observational [Patient Registry]

Start Date: Aug 2017

open study

RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future. PURPOSE: This research study is collecting samples from patients with amyloid diseases

Type: Observational

Start Date: Jan 2000

open study

This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.

Type: Observational

Start Date: Dec 2023

open study

The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions. Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal. PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available. This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random. The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.

Type: Interventional

Start Date: Nov 2023

open study

A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time.

Type: Interventional

Start Date: Feb 2023

open study

This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week intervention consists of health and narrative sessions and youth-led activities. For this cluster randomized controlled trial [RCT} at 10 sites, the investigators will recruit 45 parent-child pairs per site for a total of 450 parent-child pairs. The primary outcome is child participants' body mass index (BMI) z scores. Secondary outcomes include children's sugar-sweetened beverage intake, water intake, and youth empowerment. Change in outcomes over time among participants in the intervention sites will be compared to change in outcomes over time among participants

Type: Interventional

Start Date: Oct 2020

open study

The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.

Type: Interventional

Start Date: Feb 2020

open study

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Type: Interventional

Start Date: Feb 2019

open study

We believe extreme longevity is due to specific genes which function to delay aging and prevent disease. The purpose of our research is to identify the genes/mutations associated with healthier aging; to understand the biological functions of these genes/mutations; and to develop therapies to replicate these preservative genetic activities in individuals who do not have the genetic profile for longevity.

Type: Observational

Start Date: Jul 1998

open study

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.

Type: Observational

Start Date: Aug 2023

open study

HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how contextual risk factors influence CAI and develop behavioral strategies that modify risk factors directly or reduce their influence on behavior. This study will examine the mechanisms through which one of the central contextual risk factors, heavy drinking, influences sexual decision processes in the natural environment and test the benefit of a brief intervention designed to reduce sexual risk behavior among those who engage in heavy drinking.

Type: Interventional

Start Date: Nov 2023

open study

In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Building on the combined experience the proposed study will progress in new directions to: 1. Adapt, refine, and standardize two 12-week treatment protocols (Tai Chi and a Wellness control condition) for Veterans diagnosed with PTSD and chronic musculoskeletal pain during Phase One. Tai Chi and Wellness interventions will be adapted for delivery via a videoconferencing platform for the population and piloted in a 'dry run'. 2. Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two. 3. Utilize information from this trial to plan and design a large randomized control study evaluating the efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic musculoskeletal pain.

Type: Interventional

Start Date: Jun 2023

open study

To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, we have little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support. AMBIT is a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Ministry of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis.

Type: Observational

Start Date: Dec 2019

open study

To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, there is little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support. AMBIT a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Ministry of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis.

Type: Observational

Start Date: Dec 2019

open study

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.

Type: Observational

Start Date: Nov 2017

open study

Stroke is among the leading causes of long-term disability worldwide. Post-stroke neuromotor impairments are heterogeneous, yet often result in reduced walking ability characterized by slow, asymmetric, and unstable gait patterns. Rhythmic Auditory Stimulation (RAS) is an emerging rehabilitation approach that leverages auditory-motor synchronization to retrain neuromotor control of walking. Indeed, walking with RAS can enhance walking rhythmicity, gait quality, and speed. RAS is a potentially valuable tool for walking rehabilitation after stroke; however, despite extensive research evidence on the overall benefits of RAS in people with chronic stroke, the notable variability in the walking characteristics of individual patients is likely to influence the effectiveness of RAS intervention, and thus requires study. Furthermore, beyond stroke-related factors, age-related changes may also affect how well individuals post-stroke respond to RAS. This study aims to recruit 24 individuals post-stroke and 20 older adults to evaluate the effects of stroke- and age-related neuromotor impairment on RAS intervention. Each study participant will complete two six-minute walk tests: one without RAS (baseline) and the other with RAS delivered using a metronome. The investigators hypothesize that post-stroke individuals will, on average, exhibit a positive response to RAS intervention (i.e., walk farther and with greater gait automaticity (i.e., reduced stride time variability), with the degree of response predicted by specific baseline characteristics. Furthermore, the investigators anticipate that these walking enhancements will be accompanied by improvements in gait biomechanics and a reduction in the metabolic cost of walking. The investigators hypothesize that older adults will exhibit similar, but attenuated, effects of RAS.

Type: Interventional

Start Date: Sep 2023

open study

The research program will evaluate the theoretical claim that age-related memory and cognitive decline in humans result from the inefficient orchestration of rhythmic activity within large-scale cortical networks. The results will contribute to the basic science groundwork for developing future non-pharmacological interventions aimed at boosting memory and cognition in aging and clinical populations.

Type: Interventional

Start Date: Sep 2019

open study

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Type: Interventional

Start Date: Dec 2016

open study

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.

Type: Interventional

Start Date: Jun 2022

open study

Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.

Type: Interventional

Start Date: Mar 2022

open study