24 Clinical Trials for Various Conditions
This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.
The investigators will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is a strategy for guiding individuals through complex health systems, and the investigators hypothesize that this may be a promising approach for helping homeless-experienced people overcome their unique barriers to obtaining LCS. The investigators will aim to recruit 300 people to participate in this research study; 100 will be randomly assigned to arm 1 (usual care) and 200 will be randomly assigned to arm 2 (patient navigation). Randomization of participants will be stratified by smoking status, housing status, clinical site, and whether they have previously discussed LCS with their primary care provider (PCP) to ensure balance between study groups on these variables. People assigned to the usual care arm will be referred back to their PCP for further management. People assigned to the patient navigation arm will be given the chance to work with a LCS navigator. The navigator will assist participants and their PCPs with all aspects of the LCS process in addition to offering brief tobacco counseling for current smokers. The primary aim of the trial is to determine-among homeless-experienced people who are eligible for LCS-the effect of patient navigation on 1) LCS LDCT completion at 6 months post-enrollment and 2) LCS LDCT completion at 6 months with diagnostic follow-up of abnormal results within 1 month of the recommended time frame. Study outcomes will be assessed by examining participant health records. Following the intervention, qualitative interviews will be conducted with 40 participants and 10 BHCHP PCPs to better understand how the LCS process unfolds in the setting of homelessness, the ways in which the navigator facilitated this process, and opportunities for improving the navigation intervention for future use.
The purpose of this study is to determine whether homeless individuals will complete a living will and whether guidance enhances rates of completion and to see whether filling out a living will has any impact on the care given at the end of life.
This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.
"Aligning Resources to Care for Homeless Veterans" (ARCH) will study ways to best organize and deliver primary care for homeless Veterans. The investigators will assess 4 different adaptations of the PACT primary care model in a mixed methods study that includes multi-center, randomized-controlled trials of embedded peer-mentoring within different iterations of the PACT model, focus groups of study participants assessing satisfaction, treatment engagement and self-efficacy within the different care models and a cost-utility analysis to determine the most cost-efficient approach to organizing care for this population. Findings from this study will help determine optimal care approaches for reducing emergency department visits and acute hospitalizations, increasing patient satisfaction, and improving chronic disease management. Findings from this study will also substantively add to our understanding of health seeking behavior and the care of vulnerable/high-risk Veteran populations as well as clinical systems design. This project reflects a true "field-based study" to identify optimal and feasible approaches to patient care within our current VHA system. Finally, it will help inform pressing policy issues relevant to two identified T-21 priority areas: Ending Veteran Homelessness in 5 Years and Transforming to a Patient Centered Primary Care model.
The objectives of this study are to test an evidence-based model for improving primary and preventive care engagement among homeless Veterans not currently receiving care and to demonstrate the additive benefit of primary care-based treatment engagement by this population.
This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.
Many homeless Veterans with serious mental illness (SMI) enroll in the VA's Supported Housing (VASH) program but struggle to obtain and sustain housing. Social skills are an important-but underappreciated-determinant of housing outcomes for homeless adults. The investigators hypothesize that homeless Veterans with SMI who participate in a social skills training program, tailored for housing-related social skills, will obtain housing quicker, retain housing longer, and show improved mental health outcomes compared to Veterans with similar needs not participating in such a program.
The purpose of this study is to examine the effectiveness of an internet-based contingency management program for smoking cessation in persons who are homeless. Thirty homeless smokers will be enrolled in the study. Participants will receive payment based on their own low carbon monoxide readings, which indicate being quit from smoking. Participants will be prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All participants will receive a four sessions of smoking cessation counseling, and will be trained to perform carbon monoxide monitoring with a device provided by the study. They will also be provided with a mobile phone equipped with a video camera, and will use this equipment at home to monitor their carbon monoxide . Participants will record videos of themselves taking a carbon monoxide reading and displaying the results, and will upload the videos to a secured website that is only accessible by the research team members and the participant. Payment will be based on providing carbon monoxide readings that indicate abstinence. The study is designed to address the following aims: Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency management for helping smokers who are homeless stop smoking. Specific Aim 2: To evaluate how effective internet-based contingency managementis on decreasing smoking in smokers who are homeless.
This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of anticipated study procedures.
The goal of this clinical trial is to learn about how unconditional cash payments equivalent to $1,000 for 24 months (also called 'guaranteed income') might help families experiencing homelessness and/or unstable housing in Santa Clara County, California. The main questions it aims to answer are: 1. What is the impact of guaranteed income on homelessness and housing stability among families experiencing homelessness or housing instability? 2. What is the impact of guaranteed income on the health and well-being of families experiencing homelessness or housing instability? 3. In terms of size and frequency of cash payments, do families prefer monthly recurrent payments ($1,000/month) vs a larger up front amount followed by smaller monthly payments ($6,500/month, then $500/month)? Is one payment strategy more helpful than the other in terms of achieving improved housing stability, health, or other measures of well-being?
This study is designed to assess the effect of implementing a mobile health (mHealth) strategy using text messaging for hypertension (HTN) management among hypertensive homeless persons with uncontrolled blood pressure age 21 or older in shelter-clinics in New York City (NYC). The study uses a randomized clinical trial design (homeless, n=120) and semi-structured interviews (homeless, n=30; providers, n=20). The control group will receive text messages for usual standard care/healthy lifestyle during a 6-month follow-up period. The intervention group will receive text messages geared towards both standard care/healthy lifestyle and blood pressure control. At the end of study period, the investigators will assess changes in blood pressure (BP) measurements, adherence to clinic visits, and adherence to medication, and the investigators will compare them between the two groups. Qualitative interviews with both patients and providers who provide services to the homeless in shelter settings will develop a better understand barriers and opportunities regarding BP control. The investigators hypothesize that those individuals randomized to the intervention will experience a reduction in blood pressure (8mmHg systolic BP or diastolic BP) and will exhibit better adherence to blood pressure medications and appointments compared to the control group.
Use of acute care services (e.g., hospitalizations, Emergency Department visits) contributes substantially to the cost of healthcare for Veterans. Homelessness is a robust social determinant of super utilization of acute care. The goal of this project is to test if Peer Specialists trained in Whole Health Coaching can reduce homeless Veterans' frequent use of acute care.
The purpose of this study is to determine whether Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking - Criminal Justice version (MISSION-CJ) is effective for reducing criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, employment, community integration) among justice-involved, homeless Veterans with a co-occurring substance use and mental health disorder.
Cognitive impairments are present in up to 80% of homeless individuals, and may contribute to homelessness in Operation Enduring Freedom / Operation Iraqi Freedom / Operation New Dawn (OEF/OIF/OND) Veterans. The investigators propose to investigate these issues in homeless, treatment-seeking returning Veterans, who arguably face multiple potential barriers to recovery and reintegration, and with whom there is the greatest opportunity to prevent long-term homelessness. The investigators plan to conduct a 15-week randomized controlled trial of an evidence-based, 10-week Compensatory Cognitive Training (CCT) intervention vs. an education control condition to examine the effects of cognitive rehabilitation in this Veteran population. The investigators expect CCT-associated improvements in cognition and functional skills and generalization to reduced levels of disability, along with improved community reintegration outcomes. By attending to and treating cognitive impairments, the investigators can potentially prevent future homelessness and its negative health consequences, resulting in both healthcare cost savings and improved quality of life for Veterans.
The study examined intensive case management for homeless Veterans in addiction treatment by integrating addiction/housing case managers (AHCM), operating from a Life Skills Training perspective, into an addiction specialty program. The primary aim was to determine whether the AHCM intervention increases number of days housed during the year following treatment entry. Secondary aims were to compare costs and cost-effectiveness of AHCM vs. time and attention control, determine if AHCM improves addiction outcomes and functional status, and examine treatment process variables associated with improved outcomes.
This study evaluates a contingency management program that rewards homeless, non-treatment-seeking substance abusing men who have sex with men (MSM) for abstaining from drugs and for performing prosocial behaviors. If this program motivates these individuals to increase prosocial and healthy behaviors and decrease drug/alcohol use, established prevention programs may modify their approaches to include contingency management, and use it to address the staggering public health problems homeless substance-abusing MSMs face on a daily basis.
The purpose of this study is to examine how services and housing provided for homeless families affect the mental health and behavior of homeless children over time.
This is a mixed methods pilot feasibility trial of HEALthy Beginnings, an innovative, nurse-driven intervention. Middle-aged and older, homeless women (MAO-HW) will participate in the HEALthy Beginnings intervention and select MAO-HW will be invited to participate in post-intervention qualitative focus groups to evaluate the program.
This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone (together called MI-CBTech). The goal of the intervention is to improve community integration in Veterans with serious mental illness (SMI) who have experienced homelessness. A time- and format-matched control arm will include remote mindfulness training. 50 Veterans with SMI experiencing homelessness will be randomized to one of the two arms (25 per arm).
People experiencing homelessness (PEH) are at exceptionally high risk of frequent emergency department (ED) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. Evidence-based interventions of particular promise for reducing ED and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ED or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mHealth technology to link PEH with appropriate community-based health and social services. This project builds on evidence from two feasibility studies in order to integrate and test a mHealth intervention, comprised of GPS technology and text messaging components, into a community setting to connect PEH with a community-based case manager and healthcare and social services. Our hypothesis is that integrating the mHealth intervention into an established, trusted navigation center for PEH will mitigate barriers to care and gaps in the care continuum resulting in decreased ED and hospital use and improved health outcomes and attainment of social needs. The study aim is to conduct a stratified RCT to compare a mHealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in PEH.
The SAFE study examines the effects of brief mindfulness-based cognitive-behavioral intervention aimed at improving risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking) in order to reduce substance use and victimization among young people (ages 18-21) experiencing homelessness.
Highly-effective, pan-genotypic direct acting antivirals (DAAs) have made elimination of hepatitis C virus (HCV) a real possibility. A minority of the population infected with HCV has access to care or been prescribed such HCV treatment. Among people experiencing homelessness in the US, and seeking care at Health Care for the Homeless (HCH) clinics, prevalence is 31%, and 70% among people who experience homeless and inject drugs. In N. America, 55% of people who inject drugs (PWID) have HCV. Austin, TX has over 7,000 people experiencing homelessness with about 20% having a substance use disorder. Treatment of HCV via DAAs is feasible and effective in primary care settings, and is as effective as treatment by specialists. Among people with opioid use disorder receiving opioid agonist therapy it's both effective and cost-effective. Treatment in the primary care setting has also been shown to be feasible and effective for people experiencing homelessness, with supporting evidence of engaging and retaining people in care. Furthermore, a novel HCV treatment model, featuring a simplified HCV treatment algorithm for front-line health care providers (primary care physicians, Nurse Practitioners, Physicians Assistants), has now been published, to help increase capacity, scale-up treatment and achieve elimination. This study takes the foregoing new simplified approach one step further: Implementing this simplified algorithm for front-line health care providers in primary care settings caring for high-risk populations such as individuals experiencing homelessness and PWID. The novelty is providing treatment in diverse primary care settings, and targeting clinical sites serving high-risk populations, including people experiencing homelessness and PWID. Investigators use an implementation science approach to study the feasibility and effectiveness of the HCV treatment model in achieving HCV cure in high-risk populations. Investigators hypothesize that by training front-line health care providers on a simplified, low-barrier HCV treatment model and adapting it using a locally contextualized, protocol-driven approach, investigators will effectively scale up HCV treatment across multiple primary care clinical sites serving high-risk populations, yielding sustained virologic response at 12 weeks (SVR-12) in 75% of enrolled participants. Investigators predict theHCV treatment model to measure favorably across implementation process and outcome measures of reach, adoption, implementation, and maintenance.
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment at the same non-clinical community space may improve uptake and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available DAA therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site via clinical research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at point of diagnosis. All evaluation, medication dissemination, and follow-up care will take place at the project site. The investigators will estimate the effect of on-site point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2) completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by study site. A secondary product will be a lesson learned guide of recommendations for implementing a POD on-site test and treat program for dissemination beyond San Francisco.