Boston University - Clinical & Translational Science Institute

To achieve global goals for the treatment of HIV, many countries are piloting 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, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. Alternative Models of ART Delivery: Optimizing Benefits (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. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Zambia Ref. No. 2019-Sep-030), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale. The Sentinel-Zambia study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-SA was conducted in 2021. The AMBIT 2.0 protocol will allow up to four additional annual rounds of data collection, in 2022-2025. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Zambian healthcare facilities and their affiliated DSD models in Round 1. Round 2 (2022) and later rounds will collect the same types of data at 12 facilities in Zambia and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Zambian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.

Type: Observational

Start Date: Jun 2021

open study

To achieve global goals for the treatment of HIV, many countries are piloting 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, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. 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. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Malawi NHRC 2376), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale. The Sentinel-Malawi study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-Malawi was conducted in 2021. The investigators are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Malawian healthcare facilities and their affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12 facilities in Malawi and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Malawian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets.

Type: Observational

Start Date: Jun 2021

open study

Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level. SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include at least four approximately annual rounds of data collection between 2021 and 2025. As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.

Type: Observational

Start Date: Jun 2021

open study

The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Adults in the SAD group who do not respond enough to group CBT may be offered the opportunity to complete an additional 12 weeks of individual CBT while receiving SSRI medication (sertraline, see below) for SAD. Data collected from participants who experience anxiety will be compared to a group of 50 participants with little or no social anxiety, who will serve as a comparison group.

Type: Interventional

Start Date: May 2023

open study

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Type: Interventional

Start Date: Jul 2023

open study

The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged populations with chronic diseases. In the previous phases of this project the investigators developed a social risk score to identify social needs among medically under-served patients with special emphasis on application among African American patients with low income and chronic diseases who face social determinants, risk factors, and needs (SDRN) challenges. The investigators also developed a clinical decision support (CDS) tool to present the social risk score to clinical providers and sought feedback from different users on the face and content validity of the CDS tool. In the current project the investigators will run a randomized clinical trial (RCT) study to pilot test the new risk score and CDS tool in selected primary care clinics at Johns Hopkins Health System (JHHS) and in collaboration with selected community-based organizations (CBOs). This system will help identify, manage, and refer patients with both high levels of disease burden and modifiable SDRN challenges.

Type: Interventional

Start Date: Apr 2023

open study

GRAIL is a Randomized Controlled Trial (RCT) among 300 HIV-positive persons with heavy alcohol consumption (by NIAAA definition) who have had detectable HIV viral load (HVL) at least 6 months after their HIV diagnosis. This trial aims to test the efficacy of gabapentin versus placebo to achieve undetectable HVL and assess the impact of gabapentin compared to placebo on alcohol consumption, pain severity, ART adherence, and engagement in HIV care. HIV viral load will be assessed at 3 (primary), 6 and 12 months via laboratory test. Eligible participants will be randomly assigned into one of two study arms: 1) gabapentin (1800mg/day target dose) for 3 months vs. 2) placebo for 3 months. All participants will receive evidence-based counseling for alcohol and either an active medication or placebo.

Type: Interventional

Start Date: Nov 2023

open study

Persistent developmental stuttering affects more than three million people in the United States, and it can have profound adverse effects on quality of life. Despite its prevalence and negative impact, stuttering has resisted explanation and effective treatment, due in large part to a poor understanding of the neural processing impairments underlying the disorder. The overall goal of this study is to improve understanding of the brain mechanisms involved in speech motor planning and how these are disrupted in neurogenic speech disorders, like stuttering. The investigators will do this through an integrated combination of experiments that involve speech production, functional MRI, and non-invasive brain stimulation. The study is designed to test hypotheses regarding the brain processes involved in learning and initiating new speech sound sequences and how those processes compare in persons with persistent developmental stuttering and those with typical speech development. These processes will be studied in both adults and children. Additionally, these processes will be investigated in patients with neurodegenerative speech disorders (primary progressive aphasia) to further inform the investigators understanding of the neural mechanisms that support speech motor sequence learning. Together these experiments will result in an improved account of the brain mechanisms underlying speech production in fluent speakers and individuals who stutter, thereby paving the way for the development of new therapies and technologies for addressing this disorder.

Type: Interventional

Start Date: Apr 2023

open study

To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.

Type: Interventional

Start Date: Dec 2022

open study

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Type: Interventional

Start Date: Dec 2022

open study

This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

Type: Interventional

Start Date: Mar 2022

open study

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.

Type: Interventional

Start Date: Dec 2021

open study

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Type: Interventional

Start Date: Jan 2021

open study

Developing novel methods of patient communication is crucial in providing value-based care to orthopedic patients. Healthcare technology platforms have been developed to improve patient communication methods particularly for the administration of patient-reported outcome measures (PROMs). However, the majority of these interventions rely on web-based platforms that require patients to have computer access. Among American households earning less than $30,000 per year, only 59% have access to a desktop or laptop and just 47% have broadband internet at home compared to mobile phone penetration which is estimated at 95% of which 93% regularly use text messages. The use of phone messaging may be the most effective means to have patients complete PROMs. The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded, clinically validated method of tracking patient-reported outcomes to efficiently assess patient health status. PROMIS utilizes Item Response Theory (IRT) and computerized adaptive testing (CAT) to improve measurement precision and decrease survey time as compared to traditional PROMs. The purpose of this two-phase study is to utilize Memora Health's text-messaging platform to collect web-based PROMIS CAT surveys from patients (Phase 1) and use this information to right-size clinic visits (Phase 2).

Type: Interventional

Start Date: May 2021

open study

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.

Type: Interventional

Start Date: Mar 2021

open study

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Type: Interventional

Start Date: Jul 2020

open study

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.

Type: Interventional

Start Date: Aug 2021

open study

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

Type: Interventional

Start Date: May 2020

open study

This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.

Type: Interventional

Start Date: Mar 2018

open study

Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups.

Type: Interventional

Start Date: Mar 2024

open study

Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease.

Type: Observational

Start Date: Mar 2024

open study

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

Type: Interventional

Start Date: May 2023

open study

The objectives of this research are to determine: - the burden of intestinal parasitic infections among persons living with pulmonary tuberculosis (TB) - whether intestinal parasitic infections alter TB treatment outcomes, including speed of sputum clearance and treatment outcomes - the impact of malnutrition on speed of sputum clearance and TB treatment outcomes - whether nutritional supplementation improves speed of sputum clearance and treatment outcomes In this study the researchers will investigate how intestinal parasites impact the nutritional status of TB patients before the start of nutritional supplementation and how they alter the trajectory of weight gain in those receiving supplementation by analyzing results from 2 cohorts. LEOPARD Cohort 1- - Control-Enroll TB cases, screen for undernutrition, obtain stool for intestinal parasite screening by polymerase chain reaction (PCR), and assess them for treatment outcomes and weight gain - TB LION (Learning Impact of Nutrition) - Enroll TB cases, provide nutritional supplementation for 6 months (as part of existing TB LION study), screen for undernutrition, obtain stool for intestinal parasite screening by PCR, and assess them for treatment outcomes and weight gain LEOPARD Cohort 2 - - Enroll TB cases, screen for undernutrition, obtain stool for internal parasite screening by PCR, and assess them for treatment outcomes and weight gain.

Type: Observational

Start Date: Apr 2022

open study

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

Type: Interventional

Start Date: Aug 2021

open study

This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments.

Type: Interventional

Start Date: Sep 2021

open study