64 Clinical Trials for Various Conditions
This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized to one of two groups (Standard of Care vs. Enhanced Standard of Care). Patients in the Standard-of-Care group will receive established clinical care and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. The investigators hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.
The goal of this project is to understand the household level transmission dynamics and factors that predict transmission of SARS-COV-2 between pediatric and adults in the household. The novel coronavirus SARS-CoV-2 has spread all around the world and testing has posed a challenge globally. Not much is known about who does and does not acquire SARS-CoV2. It is also unknown who will show symptoms or progress severe disease or death from COVID-19. Children tend to have milder symptoms or none at all. Therefore, few children have ever been tested, so it is unknown if they get the infection as much as anyone else. Health care providers are highly exposed, and they do not get tested unless they show severe symptoms. If groups like children and health workers are infected, they can unknowingly spread SARS-CoV-2, unless they practice behaviors like self-isolation very strictly. The investigators aim to measure the prevalence of SARS-CoV-2 in children and health care workers at a large urban health center. The investigators will also measure how many people in the household of the positive children and health care workers also get SARS-CoV-2 infection. Lastly, the investigators will see what other risk factors affect who acquires SARSCoV-2 from inside or outside of the household clusters.
This study will test and follow persons quarantined at home after testing positive for SARS-CoV-2 (COV) aged 18 years and older and their household members aged 1 year and older. The purpose of this research study is to understand how often COVID-19 (Coronavirus Disease 2019) spreads in the household when someone who tests positive for the virus self-isolates at home. The purpose of the extension part of the study is to help us understand long-term immunity to COVID-19. We are interested in how our immune system might still protect us from COVID-19 even after antibody levels decrease or are no longer detected. We are also interested in how immunity to COVID-19 is different in kids vs. adults.
The goal of this study is to find ways to help families with children who have limited incomes get better access to healthy and culturally appropriate foods. The study will test a program called "medically tailored grocery box delivery," which sends boxes of healthy groceries to families based on their specific health needs. The study aims to answer: 1. Can this grocery delivery program improve families' access to healthy foods and support better eating habits? 2. Will families use the groceries provided, and how effective is the program overall? To answer these questions, researchers will: * Work with the community to design the grocery program and make sure the foods meet families' cultural preferences. * Test how well the program can be carried out in real-world settings. * Compare how the program affects families' access to healthy food, eating habits, and use of the grocery boxes.
This study will evaluate the effects of two different approaches to support healthy family mealtime, sleep, and screentime routines: A parent leader-guided online program that promotes parent and child self-regulation as a means to improve healthy family routines versus an asynchronous program that provides parents information about healthy family routines. Families will be randomly assigned to either of these programs and changes in parent and child outcomes will be evaluated.
Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.
The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group. This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit.
Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.
The City of Pomona is launching the Pomona Household Universal Grant (HUG) program in the Summer of 2024. Pomona HUG is a pilot project that will provide 250 parents/caregivers with children under 4 years old $500 a month for 18 months. Pomona's guaranteed income (GI) initiative provides relief for the most economically vulnerable households. The study will investigate the impacts of GI on financial security, material hardship, health and well-being, food security, social support, parenting, and childhood development. The intervention group will be compared to a control group of 350 parents/caregivers receiving only a nominal ($20) amount per month during the 18 month period.
The goal of this clinical trial is to test whether the Food FARMacia intervention to reduce food insecurity is feasible and accepted among families with an infant age 6 to less than 18 months receiving pediatric primary care. All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.
The purpose of this study is to describe the long-term health effects of COVID-19 in a population of mostly Black and Latinx individuals and their households who were diagnosed with COVID-19 at Columbia University Irving Medical Center. In New York, the upper Manhattan and south Bronx communities neighboring Columbia University Irving Medical Center (CUIMC) have been two of the most impacted communities of the COVID-19 pandemic. These neighborhoods are predominantly non-Hispanic black or African American and Latinx. This study will invite people who tested positive for COVID-19 and/or were treated at Columbia University Irving Medical Center to: 1) take a survey to ask about current symptoms and any health problems and 2) ask permission to review COVID-related health history including COVID-19 testing results (from the medical record) since infection to learn about health effects after COVID-19 infection; 3) invite anyone in their household to take a survey; and 4) for up to 500 patients who were hospitalized for COVID, give the option of doing a nasal swab to test for SARS-CoV-2 virus and blood test to check for antibody up to 12 months after diagnosis, to compare how results are different 12 months after infection. The goal is to learn about how the severity of person's infection in 2020 influences long term health effects and how others in their household are impacted by COVID-19.
Since its passage in 2010, the Affordable Care Act (ACA) has helped reduce the uninsured rate to record lows, but changes in insurance coverage over time, known as churn, remain a concern. A recent survey found that nearly 25 percent of respondents reported a change in coverage over the previous twelve months. Among the most common reasons for churn is the loss of Medicaid eligibility, placing low-income populations at risk of a coverage gap. To date, little evidence exists on effective strategies states can use to facilitate Medicaid to Marketplace coverage transitions, an issue that has become more pressing amid projections that upwards of 15 million people could lose Medicaid eligibility once the COVID-19 public health emergency expires. To address this gap and to inform Marketplace administrators, during a Special Enrollment Period (SEP) in 2017 in California's ACA Marketplace, we conducted a randomized controlled trial to examine the effect of email reminders, personalized telephone outreach, as well as the combination of the two forms of outreach on ACA enrollment among households who recently lost Medicaid and became eligible for subsidized Marketplace coverage. During the SEP at the end of August 2017, the investigators randomly assigned households to one of four arms based on the last digit of their household identifier: a control group assigned to receive no outreach beyond an initial eligibility determination notice; an email-only group assigned to receive an initial eligibility determination plus email reminders about signing up for marketplace coverage; a phone-only group assigned to receive an initial eligibility determination plus a phone call offering enrollment assistance from a service center representative (SCR); a phone + email group assigned to receive an initial eligibility determination, email reminders about signing up for marketplace coverage and a phone call offering enrollment assistance.
Using a focused implementation research framework, the EPIS (Exploration, Preparation, Implementation and Sustainment) model in a type-2 hybrid design, the study will be conducted in 3 phases: 1) A pre-implementation phase that will use the Exploration and Preparation domains of EPIS to: a) explore barriers and facilitators of Clean Fuel- Clean- Stove (CF-CS) use, and b) develop a culturally-tailored CM strategy for CF-CS use; 2) An Implementation phase that will use the Implementation domain of EPIS to compare in a cluster RCT of 32 peri-urban communities (640 households), the effect of CM vs. a self-directed condition (i.e. receipt of information on CF-CS use without CM) on adoption of CF-CS use; and systolic BP reduction; 3) A post-implementation phase that will use the Sustainment domain of EPIS to evaluate the effect of CM strategy vs. self-directed condition on sustainability of the CF-CS use in 640 households across the randomly assigned 32 peri-urban communities in Nigeria. The Lagos State University College of Medicine (LASUCOM) working with the MOH will oversee research coordination in Nigeria.
The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection. All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective
* organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23 * Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25 * Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27 * Additional study using this technique is warranted to look at reliability and cost-28 effectiveness
This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies. Up to 5 participants from the same household may be enrolled. The objective is to estimate the likelihood of NAb seroconversion to AAV9 in household contacts of a patient in one of the interventional studies who is treated with fordadistrogene movaparvovec gene therapy.
This study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China. These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). This will be a prospective, single-center observational study involving human subjects. IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH). IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection. To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing. Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time. Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study. Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing. For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test. Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive. All testing will be performed in a two-week window. All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment. We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care. The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum. One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020. The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.
Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo
The purpose of this study is to evaluate the effect of the probiotic Lactobacillus rhamnosus GG (LGG) and the effect of COVID-19 on the microbiome (the microorganisms that live in and on the human body) in exposed household contacts of COVID-19. This is a randomized, double-blind, placebo-controlled study, meaning subjects will be randomly assigned to receive LGG or a placebo (an inactive substance given in the same form as the active substance) and will not know which product they are receiving. Subjects will participate in the study for around 60 days. All subjects must refrain from taking any other probiotics while on study. All subjects must have access to e-mail and the internet to complete study questionnaires. Participation in this study entails taking LGG/placebo for 28 days, responding to questionnaires, and providing stool and nasal swab samples.
This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
This pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated.
The purpose of this study is to test the use of a smartphone app as a way to measure food waste. Investigators propose to improve the accuracy and convenience of household food waste measurement so that consumer food waste program evaluations yield more power, less bias, less measurement error, and greater representation of targeted populations.
This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents (RMA) Interventions developed and implemented by Pathfinder International to increase contraception use and contraception use intentions among married adolescent girls ages 13-19 in three rural districts of the Dosso region of Niger. Intervention models (gender-synchronized household visits and small groups) will be tested using a randomized 4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as the control group and will not receive any intervention. The quantitative component will consist of collecting quantitative baseline, 16-months follow-up, and 27-months survey data from randomly selected married adolescent girls (n=1200) and their husbands (n=1200) who are participating in each Arm of the study. Qualitative elements will include ethnography at two time points and semi-structured in-depth interviews half way through intervention implementation. A costing and cost effectiveness analysis will also be conducted to evaluate which intervention provides the largest gain in the primary outcomes for each dollar spent.
The purpose of this prospective, randomized, controlled three-year study is to compare the effect of a year-long financial education program versus usual care on health outcomes in single mother low income households.
American Indians (AI's) are experiencing an epidemic of stroke morbidity and mortality, with higher prevalence and incidence, younger age at onset, and poorer survival than other racial and ethnic groups. With a stroke incidence more than twice that of the general U.S. population, stroke in AI's is a public health problem of staggering scope. AI's also have disproportionate burdens of many risk factors for stroke, including hypertension, smoking, obesity, and diabetes. However, no rigorous, population-based studies of stroke prevention have included AI's. The investigators at WSU, and community partners, have designed the "Family Intervention in the Spirit of Motivational Interviewing" (FITSMI), a program delivered at the household level to encourage lifestyle changes that transform the home environment and reduce stroke risk for all residents. FITSMI uses a "talking circle" format in which facilitators guide participants to identify goals for change and create a tailored plan for sustainable implementation that may target smoking, exercise, diet, or medication adherence. FITSMI requires just 2 sessions (baseline and 1 month post-baseline), with text messaging used to boost long-term adherence. In a group-randomized trial design, the investigators will recruit 360 households where Strong Heart Family Study members aged 45 and older reside. The investigators will assign half to FITSMI and half to a control condition that receives educational brochures.
Children without consistent access to sufficient and nutritious food show sustained disadvantages. To improve food security, households utilize three types of coping strategies- participating in governmental feeding and financial assistance programs; obtaining food from nongovernment providers; and using individually developed strategies. To understand the interdependencies among strategies and decision-making processes used to select them, the investigators conducted a two-phased, mixed-methods study using a socio-ecological theoretical framework. First, employing a cross sectional, observational design the investigators administered in-person surveys to 320 adults in very low food secure (VLFS) households with children. Over 1 year later, the investigators repeated select questions and conducted in depth interviews with a cohort (n=28) of participants. Descriptive statistics defined magnitude of associations among strategies. Following bivariate analysis, the investigators assessed interdependencies and factors affecting relationships with log-linear models. The investigators analyzed interviews using an hierarchically ordered, analytical coding structure. With Qualitative Comparative Analysis (QCA), the investigators developed typologies of VLFS and created models treating food security as an outcome. The association of soup kitchen use and nutritionally risky behavior was altered by Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI). Food safety-related risky behavior level related to intensity of food pantry use by participation in school food programs. Supplemental Nutrition Assistance Program (SNAP) did not affect the association between soup kitchen use and risky food safety behaviors. Key interview constructs included becoming and being short of food; coping strategies; decisions used to inform choice of strategies; and managing a devalued social status. Improved income stability was a necessary condition for improving food security.
The investigators propose a pragmatic comparative effectiveness trial evaluating several decolonization strategies in patients with Staphylococcus aureus infection, their household contacts, and household environmental surfaces. The central hypothesis of this proposal is that an integrated approach of periodic personal and household environmental hygiene will reduce S. aureus transmission in households and subsequently decrease the incidence of skin and soft tissue infections (SSTI).
The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited. The proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a Texas 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. The main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.
This project examines behavioral and household characteristics associated with food purchasing patterns.