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 245 Actively Recruiting clinical trials
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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 programs 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 interventions 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.
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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.
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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 interventions impact over time.
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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.
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Firearm violence is a serious public health issue in the United States, especially among youth aged 13 to 17. This research aims to evaluate an innovative hospital-based intervention called Elevate Virtual Reality VR designed to prevent firearm-related violence, injury, and death among young people. The study is conducted in Virginia, where firearm-related fatalities and hospitalizations have significantly increased, creating an urgent need for effective prevention strategies. The Elevate VR program is a brief 40-minute intervention combining positive psychology, motivational goal setting through gameplay, psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy. Participants include youth aged 13 to 17 who were treated for intentional or unintentional injuries, as well as youth recruited from community partners and caregivers aged 18 and older. Questionnaires assessing firearm-related violence, violent crime, attitudes, risky behaviors, personality traits, and future aspirations are completed at the start and at 1 and 3 months after baseline. Participants will complete the Elevate VR intervention and various assessments during the study period, with follow-ups at 1 and 3 months to evaluate changes in firearm-related violence and related outcomes. The study measures include firearm violence assessments, violent crime evaluations, and attitudes toward firearms. This study is sponsored by Virginia Commonwealth University and aims to inform future efforts to reduce firearm-related harm among youth.
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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.
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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.
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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.
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Researchers are evaluating the safety, effectiveness, and how the body processes different single rising doses of CS-1103 when given by intravenous infusion to otherwise healthy adults with methamphetamine use disorder who are not seeking treatment. Participants receive a clinically relevant dose of methamphetamine hydrochloride 30 mg IV alongside the study drug or placebo. This phase 2 trial focuses on methamphetamine intoxication and related disorders in adults aged 18 to 55 years. Participants are randomly assigned to receive methamphetamine HCl 30 mg followed either by a placebo saline or one of four escalating doses of CS-1103 via intravenous infusion. The study uses a sequential model to assess each doses safety and pharmacokinetics. The treatment involves a single administration of methamphetamine followed closely by the study drug or placebo. During the study, participants are monitored for adverse events related to CS-1103 through physical exams, electrocardiograms, vital signs, and laboratory tests over three days plus a follow-up on Day 10. Urine samples are collected for 48 hours to measure methamphetamine excretion, and blood and urine samples are taken to track CS-1103 levels over 48 hours. The total participation time includes initial dosing and monitoring through Day 10.
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Researchers are evaluating the Brief Violence Intervention-Virtual Reality BVI-VR program to reduce firearm-related violence, re-injury, and death among violently injured adults aged 18 and older. This study will use data from criminal background checks, hospital records, state data, clinical assessments, and self-reports to measure firearm-related violence and its psychosocial mediators. The study also aims to assess the economic efficiency of BVI-VR as an intervention. The BVI-VR is a hospital-based, 30-minute intervention that incorporates positive psychology, motivational goal setting through gameplay, psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy. Participants receiving BVI-VR will engage in five steps designed to address psychosocial risks and enhance protective factors for violence. The comparison group will receive a community resource brochure listing local support services. The study uses a randomized controlled trial design. Participants will be adults treated at VCUs Level 1 Trauma Center for violent injuries. They will complete self-report surveys, neurocognitive and clinical assessments at baseline and follow-ups at 3 and 6 months. Researchers will track firearm-related violence, re-injury, mortality, and psychosocial changes. Engagement with the intervention and treatment fidelity will also be monitored. The total participation period extends to at least 6 months post-randomization.
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