Abuse, including physical, sexual, and substance-related forms, presents complex challenges that clinical trials explore to improve care and support. Research studies often evaluate treatment approaches aimed at mitigating the impact of abuse and enh...

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Found 249 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

Age: 18Years +FEMALEPhase Not Applicable
1 location
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Actively Recruiting

Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.

Age: 18Years +FEMALEPhase Not Applicable
8 locations
A

Actively Recruiting

This research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence (IPV) against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages: before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the intervention's impact over time.

Age: 18Years +All GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are studying people who use intravenous drugs (PWIDs) to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

Age: 18Years +All Genders
1 location
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Actively Recruiting

This research aims to evaluate the effectiveness of Elevate VR, a hospital-based brief violence intervention using virtual reality, to prevent firearm-related violence, injury, and death among youth. Firearm violence is a major public health concern, especially for young people, with rates of firearm-related deaths and injuries increasing nationally and particularly in Virginia. The study addresses the urgent need for new and innovative interventions to reduce firearm-related harm and its significant economic impact. Participants include youth aged 13 to 17 years who have received hospital treatment for intentional or unintentional injuries or those recruited from community sources, along with their caregivers aged 18 or older. The Elevate VR program consists of a 40-minute intervention based on positive psychology, motivational goal setting through gameplay, psychoeducation, and cognitive-behavioral and dialectical behavioral therapies. The study also involves completing questionnaires assessing firearm-related violence, attitudes, beliefs, and behaviors. During the study, participants will complete assessments at baseline and again at 1 and 3 months to measure firearm-related violence, violent crime involvement, firearm attitudes, re-injury, risky behaviors, personality traits, and future aspirations. These evaluations will help determine the intervention's impact. The study is non-randomized and does not involve masking. The overall goal is to gather data to support effective violence prevention methods among youth in high-risk communities.

Age: 13Years - 17YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis (PrEP) initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.

Age: 18Years +FEMALEPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the iDECIDE curriculum, a new drug education and diversion program, in about 300 middle and high school students who have recently broken school substance use rules. This randomized controlled trial aims to see if iDECIDE improves knowledge about drugs, attitudes toward substance use, and actual substance use behavior compared to a waitlist control group. The study focuses on adolescents' understanding of drug effects, brain development, and readiness to reduce or quit substance use. Participants will be randomly assigned to one of two groups: the iDECIDE group or a waitlist control group. The iDECIDE group will complete four weekly sessions of a drug education curriculum, delivered via videoconference or in-person, each lasting 60 to 75 minutes. This curriculum covers topics such as addiction neurobiology, brain development, industry tactics, and healthy alternatives. The control group will undergo symptom and substance use monitoring during the weekly visits and may choose to join the iDECIDE program after one month. The study involves nine visits over about one year, including baseline assessment, four weekly intervention or monitoring visits, and four follow-up visits at one week, one month, six months, and one year after the intervention. Participants will complete questionnaires, assessments, and urine tests at various visits, with raters blinded to group assignment. The study will measure knowledge of drug effects and brain development, frequency of substance use, readiness to quit, and perceptions of harm. Participants will receive compensation for attending sessions and providing urine samples.

Age: 9Years - 22YearsAll GendersPhase Not Applicable
1 location
A

Actively Recruiting

Healthy Volunteer

Researchers are evaluating ways to improve well-being and child welfare outcomes among families at risk of substance misuse by engaging fathers in the Bronx and nearby communities. The study focuses on fathers who are custodial or non-custodial and aims to compare usual services with enhanced fatherhood engagement programs to support families facing substance use concerns. Participants will be randomly assigned to one of two groups: one receiving services as usual, and the other receiving enhanced services through a Regional Partnership Grant. Enhanced services include Motivational Enhancement to encourage substance abuse treatment engagement, participation in the HERO Dads fatherhood program to improve parenting skills, Contingency Management to support attendance and abstinence, and Case Management for referrals to treatment and resources. During the study, fathers and their families will be assessed at the start and after six months to measure child well-being and father engagement using various parenting and behavioral health scales. The study includes follow-ups to track changes in father involvement, mental health, and substance use, ensuring ongoing monitoring of outcomes over the study period.

Age: 18Years +MALEPhase Not Applicable
1 location
A

Actively Recruiting

Researchers are studying the safety, effectiveness, and how the body processes four different single doses of CS-1103 in adults with methamphetamine use disorder who are not seeking treatment. The study involves giving participants a controlled dose of methamphetamine hydrochloride (30 mg IV) alongside CS-1103. This Phase 2 trial aims to better understand this treatment in otherwise healthy adults aged 18 to 55 who use methamphetamine primarily by intravenous or smoking routes. Participants are randomly assigned to receive methamphetamine HCl (30 mg) followed by either a placebo (sterile saline) or one of four doses of CS-1103, all administered through intravenous infusion. The study uses a quadruple-blind design to ensure unbiased results. The treatment period includes monitoring participants for adverse events and drug levels, with follow-up assessments extending to Day 10 after dosing. During the study, participants will undergo physical exams, ECGs, vital sign checks, and laboratory tests to monitor any side effects related to CS-1103 for three days plus a follow-up on Day 10. Researchers will also measure methamphetamine and CS-1103 concentrations in blood and urine over 48 hours. The total study participation duration includes these monitoring and follow-up periods, ensuring careful safety evaluation throughout.

Age: 18Years - 55YearsAll GendersPhase 2
1 location
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Actively Recruiting

Researchers are evaluating the effectiveness of a new program called Brief Violence Intervention-Virtual Reality (BVI-VR) to reduce firearm-related violence, re-injury, and death among adults who have been injured by violence. This program is being tested in a randomized control trial with adults aged 18 and older who were treated at VCU Health. The study also aims to understand how BVI-VR affects psychological and social factors that might reduce violent behavior, and it will assess the cost-effectiveness of this intervention. BVI-VR is a hospital-based, brief 30-minute intervention that combines positive psychology, motivational goal setting through gameplay, psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy. It focuses on empowering patients to make positive choices and find opportunities to improve their well-being within their communities. Participants are randomly assigned to either the BVI-VR group or a treatment-as-usual group that receives a community resource brochure with local service contacts. During the study, participants will complete self-report surveys, clinical assessments, and neurocognitive tests at baseline and at 3 and 6 months after randomization. Researchers will collect data on firearm-related violence, arrests, re-injuries, and mortality from multiple sources including hospital records and criminal background checks. They will also evaluate engagement with the intervention and track psychosocial changes. The total follow-up period for each participant is 6 months.

Age: 18Years +All GendersPhase Not Applicable
1 location

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