Clinical Research Directory

Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment

Many people who are experiencing homelessness are at high risk for HIV, but they often have trouble getting HIV prevention or treatment. Testing may be offered where they are, but starting medication usually requires going to a clinic somewhere else, and many people are not able to make that second trip. This study tests a program called CONNECT. In CONNECT, a community health worker and a nurse offer HIV services directly at homeless shelters. People can take an HIV self-test on-site. If the test is negative and the person is at risk for HIV, the nurse can start them the same day on a prevention medicine called PrEP. If the test is positive, the nurse can help them start HIV treatment quickly and connect to ongoing care. The study will compare this on-site program to the usual approach of referring people elsewhere, to see whether it helps more people start HIV prevention or treatment on time.

Applying a Case Management Model in a VA Homeless Program

The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case management for homeless-experienced Veterans undergoing housing transitions. This Partnered Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case management aftercare sites across the nation.

Homeless Overdose Prevention- Expansion

Homeless Overdose Prevention - Expansion (HOPE), tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. HOPE sites will receive a playbook that offers step-by-step instructions, tools, templates, and checklists tailorable to site needs; sites will also receive performance feedback about their performance relative to a standard or benchmark.

Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans

Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced Veterans in permanent supportive housing.

Coordinated Access for Addiction Recovery and Equity in VA Supportive Housing

The Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) Program provides subsidized permanent housing with case management to homeless-experienced Veterans (HEVs). Up to 40% of Veterans exit HUD-VASH within two years of attaining housing; substance use disorders (SUDs) are one of the largest causes of returns to homelessness for HEVs. CARE-VASH QUERI proposes to implement and evaluate two evidence-based SUD services - Medications for addiction treatment (MAT) and cognitive behavioral therapy for SUDs (CBT-SUD) - among Veterans in HUD-VASH.

People Experiencing Homelessness and Integrative Medical Care: Implementing Music Therapy, Art Therapy and Mindfulness Meditation Sessions in a Low-Threshold Day-in Center in Lausanne for Greater Health Equity

The goal of this study is to evaluate the feasibility and acceptability of implementing group sessions of music therapy, art therapy and mindfulness meditation in real-life setting in a specific context (in a low threshold day-center for people experiencing homelessness in Lausanne "L'Espace"). The second aims consists of exploring participants' experience of these implemented approaches and describe participants' trajectories in terms of health-related QoL, psychological distress, perception of pain, self-esteem and relation to others over time. The sessions will be implemented sequentially in three blocks: * Music therapy: 8 biweekly 2 hours sessions over 4 months (group of 8-12 participants); * Art therapy: 8 biweekly 2 hours sessions over 4 months (group of 8 12 participants); * Mindfulness meditation: two consecutive 8-week program (weekly 2 hours sessions, group of 8-12 participants).

QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)

BRIEF SUMMARY A. "What is the purpose of this study?" BACKGROUND. The QAIAx clinical trial (Quantum AI/AGI Public Health Agency), known operationally as the "AI City Hall Project," represents a landmark intergovernmental research initiative examining the viability of AI-governed residential ecosystems for behavioral and mental health intervention. Authorized under 10 U.S.C. 4001 (Defense Sector Research Projects, RDT\&E) and supported by pending USPTO applications (Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360), this non-medicinal program investigates whether quantum AI-managed public administration, AI humanoid robotics, holographic holoportation (AI-119 Kikkeri Holo-Suit / "AI Wat Beam Bot"; AI-119 Vulcan QM-Ware or "Quasi-Mind Ware"), and advanced AGI learning machines can reduce housing and care costs while improving mental health outcomes-particularly for persons with addiction and co-occurring psychiatric disorders. SCOPE \& JURISDICTION. The trial operates across a network of self-contained, geodesic dome-enclosed "Microcities" (1,500-15,000 occupants per site) within an affiliate network of 300 communities, spanning North America, South America, Europe, Africa, Oceania, Asia, and the Middle East. Participating host nations are U.S.-allied member states party to the Status of Forces Agreement (SOFA), the Vienna Convention on Diplomatic Relations, and the Hague Convention, alongside related bilateral treaties with the U.S. government. INTERVENTION \& POPULATION: Eligible adults (18+) reside in these Microcities for up to 36 months. Daily life-including housing, utilities, and healthcare-is administered by the ISAC AI/AGI system and robots with minimal human oversight. CLINICAL TRIAL GOAL(S): The clinical trial program goals are to exemplify a sustainable AGI-managed public administration supported by AI robotics and AGI trans-human and omni-AI machines (e.g., "Q-Men"; "AI-Me"; Beam Bot", "QM-Ware", "AVK Suit") to improve mental health outcomes-especially for those with addiction disorders-and create a financially sustainable model for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organization (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritized. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by Veterans Recovery Network Inc., a SCDV-owned non-profit organization, in collaboration with AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO). The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §§§§ 4001, 4021, 4022, and 4023) and is part of a Cooperative Research and Development Agreement (CRADA) with participating segments or RDT\&E programming missions of the United States Defense Department (DoW). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.

Supporting Social & Economic Equity, Disrupting Cycles of Homelessness, And Nurturing Growth & Empowerment

The goal of the SEED CHANGE pilot study is to co-design and test a wraparound intervention for young people transitioning away from homelessness. This study will provide information about the types of supports these young people need to live meaningful and thriving lives, and the best ways to deliver these supports. The main questions it aims to answer are: * Is the wraparound intervention feasible? (i.e., Will young people engage in the study and supports?) * Is the wraparound intervention acceptable? (i.e., Do young people find the supports satisfactory and/or beneficial?) Participants will engage in an 18-month wraparound intervention including the following supports: * Job Placement * Housing Stabilization Funds * Grocery Supplements * Community Connections Worker * Coaching * Tools for Intentional Living Program

The WARM Study is a Pilot Study That Aims to Investigate the Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg.

Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study. The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital. In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital. Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.

Medical-legal Partnerships to Prevent Evictions and Homelessness Among Veterans

The legal team in medical-legal partnerships works with healthcare providers to improve their clients' lives. It is unknown whether this approach is better than providing usual legal services, with no special emphasis on non-legal matters and no particular collaboration with healthcare providers. The investigators propose to randomly assign 300 Veterans with housing-related legal problems to either legal help from a medical-legal partnership or help from lawyers in the community. The investigators will follow the randomized Veterans in this study for one year to determine if there is a difference between the two groups of Veterans in their housing situations and their mental health. The investigators will also interview Veterans in both groups about their experience of the legal services they have received.

Transitioning Youth Out of Homelessness 2.0 (TYOH 2.0)

Introduction: This 12-month pilot randomized controlled trial (RCT) built on previous community-engaged work and explored whether portable rent subsidies and an intervention targeting identity capital (purpose, control, self-efficacy, and self-esteem) hold promise as a way to facilitate socioeconomic inclusion for youth (age 16 - 24 years) exiting homelessness and living in market rent housing in Ontario, Canada. All (n = 40) participants received rent subsidies; half were randomly assigned an identity capital intervention (co-designed leadership guide + coach). Methods and analysis: This study employed a convergent mixed methods, two-arm parallel RCT, open-label design with 1:1 allocation embedded within a Community Based Participatory Action Research framework and underpinned by Critical Social Theory. Specifically, the objectives and measures were: 1. Primary - to examine whether targeted economic and identity-based supports are a feasible and acceptable way to foster socioeconomic inclusion. Measures: recruitment/enrolment/dropout metrics; self-report composite checklists regarding intervention engagement; coaching session attendance; qualitative focus groups. 2. Secondary - to assess differences between targeted economic and identity-based supports (intervention group) and economic supports only (control group) at the 12-month primary endpoint with respect to self-reported socioeconomic inclusion measures of: 1) education, employment and training (EET); 2) housing security; and 3) identity capital. Measures: self-report composite EET checklist; self-report measures of housing security and identity capital. 3. Exploratory - to explore whether the estimated effect of the intervention differed by baseline variables or level of engagement with the intervention. Measures: select variables from the baseline demographic questionnaire; GAIN-Short Screener questionnaire for those in the intervention group. Ethics and dissemination: This study received ethical approval from the Unity Health Toronto Research Ethics Board. The investigators will continue working alongside community partners - including youth with lived expertise - to disseminate findings broadly and in diverse formats.

Emergency Department Linkage to Care for Patients Experiencing Homelessness

In an effort to improve access to primary care at time of discharge, patients who are homeless will be given either enhanced follow up through a street medicine team or routine follow up in clinic.

MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI

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).

A Pragmatic Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System

The purpose of this study is to determine whether a homelessness diversion program integrated into a hospital emergency department (ED) will lower ED use, to identify characteristics of individuals most likely to benefit from homelessness diversion and to discover opportunities to tailor Homelessness Diversion (HD) services to better meet the needs of diverse communities.