Treatment Trials

90 Clinical Trials for Various Conditions

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RECRUITING
Evaluating an Evidence-Based Family History Screening Program Adapted to Increase Reach and Uptake of Screening for BRCA-Associated Cancers in Rural Public Health Clinics
Description

This clinical trial adapts and evaluates the effectiveness of a family history screening program (GA CORE) for increasing uptake of genetic screening for BRCA-associated cancers in women who have received care in rural public health clinics in Southwest Georgia. Brief and low-cost family history-based screening assessments to identify families at high risk for BRCA-associated cancers have been endorsed by national guidelines and public health organizations. Georgia is among the few states to have implemented statewide family history screening for BRCA-associated cancers. Despite its potential, current clinic-based approaches that identify at-risk women are not sustainable and show limited reach. Additionally, uptake of follow-up cancer screening is sub-optimal and solely focuses on women screened as high genetic risk. This trial will adapt the existing family history screening program and then evaluate it's effectiveness for increasing the number and diversity of women who receive a history assessment and subsequent access to risk-based services such as genetic counseling and testing.

RECRUITING
Improving Cancer Prevention and Control Through Academic-local Public Health Department Partnerships
Description

The purpose of this study is to understand how to leverage structures and processes of academic health department (AHD) partnerships to facilitate implementation of cancer related evidence-based programs and policies (EBPPs).

Conditions
RECRUITING
Manipulating E-Cigarette Nicotine to Promote Public Health
Description

This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.

ENROLLING_BY_INVITATION
Public Health Initiative on Alcohol Flushing
Description

The overall aim of the study is to raise awareness of alcohol flushing and its health risks to the general population. The primary objective is to see if spreading awareness of the health risks of alcohol flushing and understanding personalized genotype information will lead to changes in alcohol consumption behavior.

RECRUITING
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Description

This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.

RECRUITING
Triple-masking v Double-masking: a Trial of Scientific Publication in Public Health
Description

The trial is designed to determine whether knowledge of the identity of the authors, their institutions and of the reviewers of a given article submitted to American Journal of Public Health impacts the final editorial decision. The concept of triple masked editorial process (where editors are unaware of author identities and affiliations in addition to the authors' and reviewers' identities being masked from one another) compared to a double masked process (only authors' and reviewers' identities are hidden from one another; editors are aware of author and reviewer identities) has not been formally tested in a scientific journal, and particularly not in medicals social science, or public health journal. Triple-masking is expected to lead to greater acceptance of articles submitted overall because it will neutralize biases against some authors and reviewers because of who they are or the institutions they are related to. The triple masked editorial process, in which the editors, the authors and the reviewers ignore their respective identities will be compared to a double masked, in which the editor knows the identity of the authors and reviewers, because double masked is currently the editorial process used by the American Journal of Public Health. Even though only manuscripts are randomized, the trial will collect information about the identity of the authors (eg, genes, race/ethnicity, seniority) and the reviewers to be used for secondary analysis. In this sense it is dealing with human subjects and has obtained an exemption from the Institutional Review Board of Queens College.

COMPLETED
Georgia: Technology and WIC - A Comprehensive Approach to Public Health
Description

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Georgia WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.

COMPLETED
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Description

This study is a Phase 2 open-label, non-placebo controlled, multi-site clinical trial that will evaluate the standard SC regimen in adolescents ages 12 through 17 years, inclusive, and compared to the standard subcutaneous regimen in adults ages 18 to 50, inclusive. Approximately 135 healthy, vaccinia-naïve adults will be enrolled in a comparator arm (Arm 4) and will be given the standard, licensed regimen of 1x10\^8 TCID50 MVA-BN administered SC on Day 1 and 29. These adults (Arm 4) will be combined with the 76 healthy, vaccinia-naïve adults that received the standard SC regimen in Stage 1 (Arm 3). Together, this will be the comparator group for non-inferiority testing for the primary endpoint. Approximately 315 healthy, vaccinia-naïve adolescents will be enrolled and given 1x10\^8 TCID50 MVA-BN administered SC on Days 1 and 29 (Arm 5). The study will have a set target enrollment of at least 25% adolescents ages 12 to 14 years, inclusive, to ensure that adequate numbers of younger adolescents are enrolled. The primary objectives are 1.) to determine if peak (Day 43) humoral immune responses in adolescents ages 12 to 17 years following administration of a 2-dose 1 x 10\^8 TCID50 MVA-BN regimen administered SC are non-inferior to the response in adults ages 18 to 50 years who received the licensed 2-dose SC regimen of 1 x 10\^8 TCID50 MVA-BN ; and 2.) to describe safety of a 2-dose 1 x 10\^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.

Conditions
COMPLETED
Evaluating Public Health Interventions to Improve COVID-19 Testing Among Underserved Populations
Description

The COVID-19 pandemic has disproportionately affected people from underserved and vulnerable populations such as low-income/uninsured, unhoused, and immigrant communities. These populations in the US are at a higher risk of acquiring COVID-19 because of poverty, type of occupation, greater use of public transit, living in multigenerational housing, lack of access to quality healthcare, and more. Despite greater risk of being infected and dying of COVID-19, those in disadvantaged communities are less likely to get tested. The investigators are collaborating with community partners in Cumberland County, Maine to implement a public health intervention focused on making COVID-19 testing more accessible to underserved populations. The intervention includes a one-time in-person training on how to take an at-home COVID-19 test and then provision of at-home COVID-19 testing kits to make testing more accessible. Five testing kits are provided at the time of training and then provided every two months for a year, for a total of 35 testing kits. In this study, the investigators will evaluate the impact of the at-home testing kit intervention on COVID-19 testing behavior, knowledge and attitudes. The investigators will accomplish this aim by following a community cohort, with a goal of recruiting 150 participants - 15 participants from each of our 10 population groups of interest (three groups that access different health services for low-income/uninsured, unhoused individuals, and six different immigrant groups). The investigators will administer surveys to the cohort participants every month over a 12 month period. Every month the survey will ask about testing behavior, and every other month the survey will also ask about knowledge and attitudes towards testing. In order to ensure access to COVID-19 tests, the cohort participants will be provided at-home testing kits throughout the course of the study. The primary outcome of interest is "recommended testing behavior," which is defined as taking a rapid COVID-19 test when experiencing symptoms of COVID-19 or after a close contact exposure. The investigators hypothesize that knowledge about testing, favorable attitudes towards testing, and recommended testing behavior will increase as a result of participation in the study.

Conditions
COMPLETED
ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Description

This is an interventional research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.

COMPLETED
Effect of the COVID-19 Public Health Crisis on the Mental Health and Physical Well-Being of Cancer Patients, the Coping With COVID Study
Description

This study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. Questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.

RECRUITING
War on Melanoma™ Public Health & Education Campaign
Description

This trial studies how well a health educational campaign works in increasing early detection of melanoma in Oregon. The health educational campaign may provide information to help people learn about the early signs of melanoma. Increased education in Oregon may decrease the number of people who die from melanoma and increase the number of melanomas that are identified at an earlier stage.

Conditions
COMPLETED
Precision Public Health: Enhancing Connections to Develop Just-in-Time Adaptive Intervention Strategies
Description

The purpose of this pilot study is to examine the effects of different types of just-in-time intervention messages on daily meeting dietary, activity, and weighing goals in a sample of young adults participating in a mobile-based weight loss program.

COMPLETED
Disseminating Public Health Evidence to Support Prevention and Control of Diabetes Among Local Health Departments
Description

The purpose of this study is to identify and evaluate dissemination strategies to support the uptake of evidence-based programs and policies (EBPPs) for diabetes prevention and control among local-level public health practitioners. Dissemination strategies such as multi-day in-person training workshops, electronic information exchange modalities, and remote technical assistance are hypothesized to associate with improved access and use of public health evidence and organizational supports for program and policy decision making based on evidence-based public health.

COMPLETED
El Paso Public Health Biorepository
Description

The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.

COMPLETED
Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam Public Health System
Description

Vietnam has a smoking prevalence that is the second highest among South East Asian countries (SEACs). With a population of approximately 90 million, Vietnam also has the second largest total number of adult smokers (over 16 million) in SEA. According to the World Health Organization (WHO), most reductions in mortality from tobacco use in the near future will be achieved through helping current users quit. Tobacco use treatment, as defined by the U.S. Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of recommended care is suboptimal. The objective of this proposal is to fill the current research-to-practice gap by conducting a randomized controlled trial that compares the effectiveness and cost effectiveness of two practical and highly replicable strategies for implementing evidence-based guidelines for the treatment of tobacco use in public health clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches, and the WHO's recently released guidelines for implementing Article 14 of the Framework Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the need to integrate best practices for treating tobacco use and dependence into routine preventive care. The proposed implementation strategies also build on the growing literature that supports the effectiveness of integrating community health workers as members of the health care team to improve access to preventive services.

COMPLETED
A Public Health Program to Reduce Risk of Antepartum Depression
Description

The hypotheses were as follows: H1. Women at low-moderate risk for APD at T1 (baseline EPDS scores of 5-9) in the cognitive behavioral intervention (CBI) group will maintain low-moderate risk status and have significantly fewer APD symptoms at T2 and T3 than women at low-moderate risk for APD in the (TAU) control group (as measured by percent of participants with EPDS scores \<9 at T2 and T3 and mean score changes). H2: Women at high risk for APD at T1 (baseline EPDS scores ≥10) in the CBI group will have a significantly greater reduction in APD symptoms at T2 and T3 than women at high risk for APD in the TAU control group (as measured by percent of participants with EPDS scores \<10 at T2 and T3 and mean score changes).

Conditions
COMPLETED
Accountable Care Organizations/ Public Health Collaborative
Description

This study focuses on implementing and evaluating an evidence-based collaborative method of increasing immunization rates among preschool children, adolescents and adults within an Accountable Care Organization-Public Health collaborative. The infrastructure we will create through this project will serve as the framework for future collaborative delivery of other preventive services.

COMPLETED
Disseminating Public Health Evidence to Support State Health Department Prevention of Cancer and Other Chronic Diseases
Description

The purpose of this study is to identify and evaluate dissemination strategies to promote the uptake of evidence-based cancer and other chronic disease prevention among state-level public health practitioners. Dissemination strategies such as multi-day in-person training workshops and electronic information exchange modalities are hypothesized to associate with improved access and use of public health evidence and organizational supports for program and policy decision making based on evidence-based public health.

COMPLETED
Tobacco Cessation Via Public Health Dental Clinics
Description

The study will examine the effectiveness of public health dental practitioners using a brief office based intervention designed to help patients quit smoking or smokeless tobacco use, as compared to usual care.

Conditions
COMPLETED
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Description

This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. The study will also estimate the costs and cost effectiveness of peer adherence coaching versus control procedures; this will be done from a provider and societal perspective.

UNKNOWN
Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
Description

This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.

COMPLETED
COVID-19 Health Messaging Efficacy and Its Impact on Public Perception, Anxiety, and Behavior
Description

Effective communication is a critical component of managing pandemic outbreaks like COVID-19. This study explores COVID-19 related public knowledge, perceptions, belief in public health recommendations, intent to comply with public health recommendations, trust in information sources and preferred information sources. Participants are invited to include detailed free-text answers to make sure their COVID-19 experiences are heard.

COMPLETED
Developing and Testing a Social Network Data Capture Tool to Improve Partner Services: a Preliminary Pilot Implementation
Description

This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner Services metrics. All of this work will be conducted through an Active Implementation Framework in which we utilized a staged- approach and strong engagement with local (e.g., Chicago Department of Public Health and Howard Brown Health) and national stakeholders to explore, install, and implement a software pilot into Partner Services.

COMPLETED
Implementation of Evidence-Based Cancer Early Detection in Black Churches
Description

The aim of the proposed project is to identify an optimal implementation strategy using a set of evidence-based interventions that aim to increase early detection of breast, prostate, and colorectal cancer among African Americans as a model. These three interventions will be packaged and interwoven into a single branded project, Project HEAL (Health through Early Awareness and Learning) which will be delivered through trained Community Health Advisors (CHA) in African-American church settings. The implementation and sustainability will be evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's County, MD will be randomized to a traditional classroom training approach or an online training approach, in which the CHA training approach and level of technical assistance is varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance and training vs. online training of CHAs + monitoring and evaluation only, respectively). By varying the training methodology and level of technical assistance, we will be able to determine what level of technical assistance leads to successful implementation and sustainability. We will also identify church organizational capacity characteristics that lead to successful implementation and sustainability. The specific aims of this research are to: (1) Package the three interventions into a single branded project (Project HEAL), develop a local cancer screening resource guide, and pilot test the materials and training. (2) Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate the implementation outcomes involving treatment fidelity and identify church organizational capacity characteristics that led to successful implementation. We will compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance necessary for successful implementation. (3) Evaluate the sustainability of Project HEAL over a two-year period of time. We will identify church organizational capacity characteristics that led to sustainability, and compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance for successful sustainability.

COMPLETED
Project Sexual Awareness for Everyone (SAFE)
Description

This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.

RECRUITING
Testing Strategies to Improve Substance Misuse Prevention Research Use in State Policy Contexts
Description

If science is to inform effective substance misuse prevention policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence, yet our field lacks an evidence-based model designed for this purpose. Accordingly, a state-level randomized controlled trial (N = 30 states) of a formal, theory-based approach for appropriately supporting policymakers' use of scientific evidence--known as the Research-to-Policy Collaboration (RPC) Model is proposed. This work has the potential to reduce population-level substance misuse by improving the use of scientific information in policymaking, thus increasing the availability of evidence-based prevention programs and policies.

RECRUITING
Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention
Description

Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of high-quality, evidence-informed, services and the prevention of overdoses.

NOT_YET_RECRUITING
Free Time for Wellness 2+
Description

Physical inactivity is pervasive and prevalent in the United States, particularly among women of low socioeconomic position, and women with children. Structural and social barriers make active leisure time a rare commodity creating a pressing health issue because physical inactivity increases the risk of chronic diseases and poor health. The broad objective of this study is to test the effectiveness of Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to increase physical activity among low-resourced mothers.

RECRUITING
Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
Description

The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.