Clinical Research Directory

STI Screening for Women With Disabilities in Zambia

The goal of this observational study is to assess the prevalence of sexually transmitted infections (STIs), mental health disorders, and substance abuse among women with physical and psychosocial disabilities in Lusaka, Zambia, while exploring the intersectional factors that influence their access to healthcare services and health-seeking behaviors. The study targets women aged 18-49 years living with disabilities, a population historically excluded from STI surveillance and care despite facing heightened vulnerabilities. With approximately 376 million new curable STI cases occurring globally annually, women with disabilities face disproportionately higher risks due to biological vulnerabilities, socioeconomic disadvantages, and structural barriers. In sub-Saharan Africa, STI prevalence among women ranges from 8.5% to 32.7%, with evidence suggesting even higher rates among women with disabilities. In Zambia, disability prevalence is estimated at 29.9%, and women with disabilities have a 2.21-fold higher likelihood of HIV infection during antenatal care compared to the general population. Despite these statistics, a critical data gap exists regarding STI burden among Zambian women with disabilities. Existing research focuses on HIV in the general population, neglecting CT/NG, syphilis, and cervical cancer in disabled women. Women with disabilities encounter numerous barriers including physical inaccessibility, provider biases, 50% less sexual health education, higher rates of risky sexual behavior, stigma, and 3-4 times higher likelihood of sexual violence. Most health facilities lack disability-inclusive amenities, discouraging service access and leaving infection burden unknown. Target population includes women aged 18-49 years with physical and psychosocial disabilities residing in Lusaka district. Purposive sampling will recruit participants. Inclusion criteria: women aged 18+ with confirmed disability (WHO Assessment Schedule), willing to provide informed consent, sexually active within the past 12 months. Exclusion criteria: women without disabilities, cognitive disabilities, unable to provide consent, severely ill/hospitalized. Minimum sample size of 150 participants calculated at 95% CI with 5% margin of error, adjusted by 10% for nonresponse (target \~165 participants). At the end of the study, STI prevalence will be documented , providing comprehensive data on infection burden; quantification of anxiety, depression, and substance abuse prevalence with associations to STI status. Research Assistants and sign-language interpreters conduct health education at the recruitment site and assess eligibility. Women expressing interest are consented, after which the Research Assistants administer the WHODAS questionnaire collecting sociodemographic and disability-related data. Additionally, they will collect data on quality of life (EQ-5D-5L) and mental health status - anxiety, depression (PHQ-5), post traumatic stress disorders (PC-PTSD-5), and substance abuse (ASSIST). Women will then be transported to a health facility for Chlamydia and Gonorrhoea screening by collecting a vaginal swab for testing on GeneXpert™. At the same time, women will be screened for Cervical Cancer using Visual Inspection with Acetic Acid (VIA). Positive lesions may prompt same-day LEEP or cryotherapy. Women will also be tested for HIV/Syphilis using the Rapid point-of-care test (Bioquick™ HIV/Syphilis Duo) using venous blood, results in 10-20 minutes. Positive STI results will prompt same day treatment and partner referral. Women identified with severe mental health conditions will be referred for further management. Data will be collected on a tablet and submitted to a database created in RedCap with automated range/consistency checks. Data reviews will be conducted daily. Analysis includes descriptive statistics, prevalence with 95% exact confidence intervals, unadjusted prevalence ratios, and multivariable logistic regression using backward selection (significance set at 0.05). Ethical approval will be obtained from UNZABREC and NHRA. Informed consent will be provided in private settings. Participants may withdraw consent at any time. Risks are minimal (speculum discomfort, mild cramping, possible bleeding) and managed with standard protocols. Privacy will be protected through anonymization, study ID assignment, locked cabinets, and restricted access. Participants receive counseling on the importance of partner notification. Adverse events and protocol deviations will be reported per UNZABREC requirements.

Cognitive-Function Informed Outpatient Child and Youth Mental Healthcare

Cognitive Function Informed Care (CFIC) is a new, add-on type of care for mental health outpatients. To receive this type of care, a child/youth does something called a neuropsychological assessment, which are tests given by a special type of psychologist, called a neuropsychologist. These tests give the neuropsychologist information about how that child/youth's brain works, in a way that is unique to them. This information is called cognitive function, and it is shared with the patient and their family. This information is also shared with their mental health provider, who will work with the neuropsychologist to make sure that their treatment makes sense for their brain. One main purpose of this research is to see if it is better to receive information about cognitive function to help make treatment decisions (CFIC), or better to receive standard care without this information. To do this, participants will be randomly assigned to either receive CFIC or proceed with standard care. Between groups, we will be comparing any improvement(s) in overall function and symptoms. The other main purpose of this research is to evaluate how CFIC influences the outpatient mental health service (i.e., implementation). We will be monitoring how the service is delivered, documenting changes as needed, asking patients about their experience(s), surveying staff members and evaluating cost.

Implementation of the ASCEND Training for Supervisors in Dutch Small and Medium-sized Enterprises (SMEs)

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of the Dutch adaptation of an in-person group intervention for workplace supervisors - Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) - in Dutch Small and Medium-sized Enterprises (SMEs). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work. The primary objectives of this project are to: * Assess to what extent the Dutch adaptation of the WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and self-care practices, and in reducing supervisor stigma towards mental health conditions within Dutch SMEs. * Evaluate the impact of the ASCEND intervention on employee outcomes, including mental health and work-related outcomes among supervisees (i.e., subordinates), as well as overall organizational absenteeism rates. * Identify barriers, facilitators, and key implementation and adoption indicators to support future opportunities for scaling up the ASCEND intervention. Researchers will compare two groups to evaluate the effectiveness of the ASCEND intervention. One group will receive the training (the intervention group), while the other group will receive the training after the final follow-up period (the control group). Data will be collected from both supervisors and their supervisees (i.e., subordinates) via online questionnaires at various time points. In addition, general organizational information, including absenteeism rates, will be gathered through a representative from each participating organization. To further explore the feasibility of scaling up the ASCEND intervention within the Netherlands, qualitative data will be collected through interviews and/or focus group discussions.

A Toolkit to Improve Mental Health Treatment for Autistic Individuals

This pilot study is funded by the Organization for Autism Research (OAR). We are conducting a pilot study to improve mental health treatment for autistic individuals. First, we will conduct remote focus groups to identify barriers to mental health treatment and methods to improve treatment. Based on results, we will develop a prototype of a resource for therapists. This resource will be pilot tested in a community clinic.

Developing and Testing a Digital Health Tool for INterseCtional Stigma Assessment and Reduction at Multiple Levels and mUltiple DimEnsions (INCLUDE) to Improve HIV Care in ART Centers in Nepal

People living with HIV (PLWH) have poor clinical outcomes when they are excluded from care due to intersectional stigma related to HIV, mental health (MH), and other dimensions. Recent studies and reviews have highlighted three major challenges in identifying and addressing intersectional stigma: a lack of stigma assessment strategies that are multi-dimensional and can be incorporated into routine clinical care, a lack of tailored stigma-reduction activities, and a lack of implementation of multi-level interventions. These gaps make it difficult to recognize and address intersectional stigma, leading to poor HIV care outcomes globally. Digital health tools, co-designed with PLWH and healthcare workers (HCWs), have the potential to assist ART centers in addressing these challenges. Guided by the principles of human-centered design, our team has developed a digital tool with three components that can address the challenges in assessing, prioritizing, and addressing intersectional stigma in ART centers. The components include: 1) a dynamic assessment strategy that can be used during a clinic visit to collect both quantitative (i.e., ratings) and qualitative data (i.e., free text of client's perspectives) on stigma reported by PLWH; 2) a dashboard that incorporates this stigma assessment data alongside routine clinical data (i.e., existing registry of clients in the ART center) so that ART centers can directly link stigma with care engagement, and also identify relevant stigma-reduction activities; and 3) a repository of evidence-based, culturally appropriate activities that can reduce stigma at the intrapersonal-, interpersonal-, and clinic-levels. The three components of the digital intervention are theoretically grounded and are based on prior studies and consultations with local partners. The study aims to assess the acceptability and feasibility of INCLUDE among clients, HCWs, and ART center leads in four ART centers. For this aim, we will conduct a pilot trial at four ART centers to assess the acceptability and feasibility of INCLUDE. If successful, this study will provide an intervention that can be incorporated into routine clinical practice to systematically identify and address intersectional stigma to improve HIV care, and can be tested in a cluster randomized trial with ART centers in Nepal and other regions that face similar challenges.

Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities

Roughly 40% of those with intellectual and developmental disabilities (IDD) have mental health needs, which is twice the national average. Nevertheless, there is dearth of evidenced-based mental health treatment for youth and young adults with IDD. The disparity in access to mental health care places those with IDD at greater risk of crisis service use. While telemental health studies demonstrate potential to enhance access to care, little of this research includes those with IDD, or crisis prevention and intervention. This project will refine and evaluate telemental health services for youth and young adults with IDD delivered within START (Systemic, Therapeutic, Assessment, Resources, and Treatment), a national, evidence-based model of crisis prevention and intervention for people with IDD. The study will begin with stakeholder feedback (service recipients, families, and providers) regarding telemental health services (Aim 1). Results will be used to refine the intervention. Our team will then compare telemental health versus in-person START services in a randomized control trial (Aim 2). To our knowledge, this will be the first trial of a telemental health crisis program for the IDD population. The final goal is to understand if outcomes vary across subpopulations (Aim 3) and to identify potential disparities. If found, the investigators will work with service users, families and providers to develop a strategy to address identified disparities in outcomes. The study will be executed by an interdisciplinary team of experts engaged with stakeholder partners. Understanding the benefits of specific telemental health methods has important implications to the design of interventions, within and outside of START. This telemental health study offers promise to address disparities in access to mental health care for people with IDD.

Effect of Sun Tai Chi on the Cardiopulmonary System and Mental Health in University Students

Currently, university students face physical and mental health issues, which are reflected in low levels of physical activity, a decline in healthy eating behaviors, and a high prevalence of mental health symptoms such as stress, anxiety, and depression. Therefore, it is necessary to develop safe, effective, and sustainable interventions that support comprehensive health and provide formative experiences that reinforce the importance of developing healthy lifestyle habits and self-care. In this regard, Tai Chi has been shown to offer physical and mental health benefits. Tai Chi is a low- to moderate-intensity exercise with low joint impact, which facilitates the transition from a sedentary to an active lifestyle. Considering the health problems experienced by university students, it is proposed that a Tai Chi intervention could help produce beneficial effects on both physical and mental health. In this context, the present study aims to implement Tai Chi classes with the objective of determining their effect on the cardiac autonomic system, mental health, and the perception of benefits, facilitators, and barriers among participating university students compared to a control group.

Impact of Dog Adoption and Training in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions

The goal of this single-arm study is to learn if a dog adoption and training program can treat, prevent in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main questions it aims to answer are: * Does the dog adoption and training program decrease posttraumatic stress symptoms in veterans with self-reported posttraumatic stress symptoms? * Does the dog adoption and training program decrease stress and improve psychosocial health in veterans with self-reported posttraumatic stress symptoms? * Does the dog adoption and training program decrease inflammation, increase oxytocin, and change the structure and resting-state function of specific brain regions in veterans with self-reported posttraumatic stress symptoms? Participants will: * Attend eight one-hour professional dog training sessions within a 10-week period. * Visit the clinical research unit four times during the study for data collection.

Prospective Cohort Study of Protected Children

A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health. In France, 308,000 minors are benefiting from at least one child protective service or measure. There are few data on the health status of this population, and how it is evolving. Against this backdrop, interventions are needed to address the many needs of these children early and comprehensively, both in the short and long term. The PEGASE program, funded by the French government under Article 51, aims to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children under CPS's care. This requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program, the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children followed by the CPS at the time of their placement and its evolution over time, data which are rare in France. The main objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up.

Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes.

Community Emotional Intelligence Network to Address Mental Health Among Coastal Bangladeshis

The goal of this clinical trial is to learn if the community emotional intelligence network can improve mental health outcomes in coastal Bangladeshis affected by climate change and frequent natural disasters. The main questions it aims to answer are: * Can enhancing emotional intelligence (e.g., self-awareness, empathy, emotional regulation, etc) improve the mental health of coastal Bangladeshis? * Does the community emotional intelligence network increase resilience and coping strategies during climate-induced mental health crises? If there is a comparison group: NA Participants will: * Complete a pretested questionnaire focusing on socio-demographic characteristics, mental health impacts, and climate-change related stressors and perceptions * Attend emotional intelligence training sessions focusing on self-awareness, self-regulation, empathy, and interpersonal skills * Participate in follow-up assessments to evaluate mental health changes, emotional intelligence growth, and overall resilience * Engage with a mobile app to facilitate communication, learning resources, and connection with other community members.