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Violence, Domestic clinical trials

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NCT ID: NCT06350383 Not yet recruiting - Clinical trials for Psychological Distress

Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic.

NCT ID: NCT06330753 Not yet recruiting - Violence, Domestic Clinical Trials

Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan

TICP
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are: Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient. Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters.

NCT ID: NCT06284148 Completed - Violence, Domestic Clinical Trials

Confidential IPV Screening Tool

Start date: October 6, 2010
Phase: N/A
Study type: Interventional

Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care.

NCT ID: NCT06124950 Not yet recruiting - Infertility, Female Clinical Trials

A Couple-based Gender-transformative Intervention on IPV Against Infertile Women

Start date: May 2024
Phase: N/A
Study type: Interventional

This multicenter, two-arm, open-label, cluster-randomized controlled trial will be conducted in two hospitals in China, focusing on couples with primary female-factor infertility who are undergoing their 1st or 2nd In Vitro Fertilization and Embryo Transfer (IVF-ET) treatments. Evidence suggests that infertile women have a higher risk of experiencing Intimate Partner Violence (IPV). The trial aims to develop and evaluate a couple-based Gender-Transformative Intervention (GTI) for infertile couples to reduce IPV prevalence. Approximately 240 couples (120 per group) will be enrolled. Clusters (6 couples/cluster) will be allocated to two groups at a ratio of 1:1- GTI group and standard care group. All clusters will be randomized through stratified block randomization according to the study sites. The intervention involves educating couples about reproductive health and intimate relationships, fostering gender equality awareness, and promoting mutual understanding and support. Researchers will compare the intervention group to a control group to see if the GTI intervention results in a reduced prevalence rate of IPV and improvements in the secondary outcomes including the attitude towards male gender roles, marital quality and satisfaction, clinical pregnancy rate, and ongoing pregnancy rate.

NCT ID: NCT06100679 Recruiting - Child Development Clinical Trials

Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation

Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The goal of this stepped-wedge cluster randomized control trial is to assess whether a Ugandan community-based intervention for young fathers (ages 18-25 years) of children ages 0-3 years impacts fathers' knowledge, attitudes, and behaviors surrounding positive parenting practices, father-child interaction, harsh physical punishment of children, and intimate partner violence.

NCT ID: NCT06001307 Recruiting - HIV Clinical Trials

Supporting Trans Affirmation, Relationships, and Sex, Phase 3

STARS
Start date: June 20, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial. There are several components to this research study: - First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test. - If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys. - Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being. - Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program. - This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours. The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.

NCT ID: NCT05803265 Completed - Clinical trials for Intimate Partner Violence

Children Witnessed Violence Evaluated in a Pediatric ED

Start date: February 1, 2020
Phase:
Study type: Observational

Witnessed violence is a form of child abuse with detrimental effects on child wellbeing and development, whose recognition relies on the assessment of their mother exposure to intimate partner violence (IPV). The aim of this cross-sectional study is to assess the frequency of witnessed violence in a population of children attending a pediatric emergency department (ED) in Italy, by searching for IPV in their mother, and to define the characteristics of the mother-child dyads.

NCT ID: NCT05768217 Recruiting - Violence, Domestic Clinical Trials

Community Resiliency Collective Efficacy Intervention

Start date: June 11, 2024
Phase: N/A
Study type: Interventional

This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence.

NCT ID: NCT05609786 Recruiting - Violence, Domestic Clinical Trials

Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya

myPlanKenya
Start date: June 22, 2022
Phase: N/A
Study type: Interventional

This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors. This clinical trial portion of the study enrolls women at risk for intimate partner violence (IPV) who are referred to myPlanKenya by disseminators (i.e. "end-users"). This trial aims to evaluate the effectiveness of myPlanKenya referral on resilience, health and safety among a cohort of women referred to myPlanKenya based on disclosure of IPV or assessed to have IPV related risks.

NCT ID: NCT05608421 Recruiting - HIV Clinical Trials

1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (LWH) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV. Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits). Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.