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NCT ID: NCT05343169 Recruiting - HIV Infections Clinical Trials

Community-based Education, Navigation, and Support Intervention for Military Veterans

CENS
Start date: October 21, 2022
Phase: N/A
Study type: Interventional

Military veterans in the U.S. represent one of the populations most disproportionately impacted by the current opioid crisis. Veterans who use opioids and are not connected to the VA healthcare system have high rates of homelessness and experience higher prevalence of comorbid substance use disorder and mental health diagnoses than their "service-connected" counterparts. Due to these vulnerabilities and the observed barriers to testing and treatment among veterans-especially substance- and mental health-related stigma, drug naiveté, and limited support networks-veterans who use opioids represent a critical target for interventions designed to mitigate overdose and HIV/HCV risk behaviors. For socially isolated veterans and veterans with limited access to healthcare, programs that work outside of formal healthcare institutions and agencies are desperately needed. This application proposes to achieve the following Aims: 1) Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors; 2) Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., mental health, pain/OUD severity, age) intervention effectiveness; and 3) Explore intervention participants' and peer outreach staff perspectives on implementation as well as barriers to and facilitators of intervention effectiveness. The proposed intervention will be delivered by veteran peer outreach workers. The study will recruit 300 veterans with opioid use disorder to participate in a randomized controlled trial. The CENS intervention will engage 150 participants in ongoing educational sessions, healthcare and treatment navigation, and social support (involving both one-on-one and group social integration protocols) designed to improve self-efficacy, reduce self-stigma, increase service and healthcare utilization, and bolster knowledge. This study stands to contribute a timely, culturally-tailored innovation to overdose and HIV/HCV prevention-as-usual that, informed by the theory of triadic influence, directly confronts the social, intrapersonal, and structural-level barriers to opioid-related risk reduction among veterans. Study findings will be of great interest to community-based and civic healthcare organizations that provide overdose and HIV/HCV risk reduction outreach, as well as to agencies committed to improving healthcare engagement among veterans.

NCT ID: NCT04953338 Completed - Anxiety Disorders Clinical Trials

Mental Health Associations With Vitiligo

Start date: June 18, 2021
Phase:
Study type: Observational

This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by different ethnicity.

NCT ID: NCT04797221 Completed - Suicide Clinical Trials

Emergency Room Firearm and Medication Safety Intervention

Start date: July 1, 2021
Phase:
Study type: Observational

Seventeen United States Veterans die by suicide each day. Nearly three-fourths of those Veterans die from firearm injury or poisoning, and many seek care in VA Emergency Departments (ED) prior to suicide attempts. In 2019, the VA began screening all Veterans seeking ED care for increased suicide risk. Interventions that promote firearm and medication safety are recommended for Veterans identified as at-risk. The investigators work will provide important information that will aid the development and testing of such an intervention for Veterans who seek care in VA EDs. The investigators will interview at-risk Veterans who recently sought VA ED care to identify factors relevant to developing the intervention, and work with Veterans and VA healthcare staff to develop and test an intervention.

NCT ID: NCT04212364 Completed - Overdose Clinical Trials

An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to pilot and implement a peer mentor intervention focused on overdose prevention and care. The intervention consists of 3 sessions. During the first and second session, each participant will meet individually with a trained staff member. In the 3rd session, the participant will invite a social network member to attend the session, and these 2 participants will meet with a trained staff member.

NCT ID: NCT03908437 Completed - Opioid-use Disorder Clinical Trials

Rapid Initiation of Drug Treatment Engagement

RIDE
Start date: July 15, 2019
Phase: Phase 4
Study type: Interventional

The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. A total of 250 untreated individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will be enrolled in the study. Recruitment will take place in two targeted neighborhoods of Philadelphia (Kensington and South Philadelphia) with a high prevalence of fatal and non-fatal opioid overdose. A total of 250 participants will be engaged in the research. Following informed consent and determination of eligibility, 125 individuals will be enrolled as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as they seek treatment from the CRC Episcopal Hospital (serving Kensington area) or BAC/CRC Hall Mercer Community Mental Health (serving South Philadelphia). The intervention group will receive four weeks of treatment with buprenorphine /naloxone and support for treatment engagement provided by a case manager and a peer recovery specialist. All participants will be assessed at baseline and then 1- and 6-month following enrollment. The primary endpoint for the study is continued enrollment in medication-assisted treatment at 6-month post-enrollment. The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. The specific aims are: - Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its ability to engage participants in targeted, existing MAT treatment slots at 1- and 6-month post-enrollment. - Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and overdoses at 6-month post-enrollment. - Aim 3: To assess the acceptability and costs of the intervention. The program and patient costs of delivering and participating in the intervention will be documented.

NCT ID: NCT03821649 Completed - Overdose Clinical Trials

SOONER Feasibility Study Protocol

SOONER
Start date: January 23, 2019
Phase: N/A
Study type: Interventional

Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating emergency services, delivering basic life support and administering naloxone. The goal of the Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) trial is to identify if point-of-care OEND increases rates of satisfactory bystander resuscitative performance to simulated opioid overdose in comparison with the existing standard of care. Recruitment and retention of participants at risk of overdose, and the acceptability of the simulated overdose outcome may challenge the feasibility of the SOONER trial. The primary objective is to identify if an integrated participant recruitment and retention strategy can recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings in Toronto, Ontario. After the initial 28 participants, we are continuing to recruit up to 50 more participants in a bridging phase that leads into the full trial.

NCT ID: NCT03518021 Completed - Drug Abuse Clinical Trials

Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital

NINA-1
Start date: May 15, 2018
Phase: Phase 3
Study type: Interventional

This trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical response (return of spontaneous respiration within 10 minutes of naloxone administration) to a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment. The aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration, which is now standard treatment of care.

NCT ID: NCT03482232 Completed - Adverse Event Clinical Trials

Consequences of Doing What Should Not be Done in Primary Care

SOBRINA
Start date: October 14, 2018
Phase:
Study type: Observational

Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them and study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.

NCT ID: NCT03402672 Completed - Clinical trials for Substance Use Disorders

AWAITS: A Web-based E-health Application for Active Illicit Opioid Users

AWAITS
Start date: November 8, 2017
Phase: N/A
Study type: Interventional

The purpose of this research study is to: 1. assess how participants like the AWAITS e-health application as measured by their feedback on the intervention 2. test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies. 3. assess the proportion of participants who accept a list of local treatment providers 4. test the impact of AWAITS on interest in being tested for HCV/HIV.

NCT ID: NCT03337100 Completed - Risk Behavior Clinical Trials

The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.