Clinical Research Directory

Evaluation of the ADD'Pro Vocational Reintegration Program (ADD-PRO-EVAL)

The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital. The main question it aims to answer is: \- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services? Researchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity. Participants will: * Be randomly assigned to either the ADD'Pro program or standard employment services * If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date * If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months * Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months * A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months

The Trans-Led Care Study

This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.

Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania

This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support. The study will enroll 200 women who use drugs in Dar es Salaam, Tanzania. These women will be randomly assigned to one of three groups: Motivational Interviewing for PrEP (MI-PrEP) Only - Women in this group will receive two one-hour counseling sessions focused on HIV prevention, PrEP education, and problem-solving to help the women start and continue using PrEP. Common Elements Treatment Approach (CETA) + MI-PrEP - Women in this group will receive the same MI-PrEP counseling sessions plus additional mental health counseling (up to 14 sessions) tailored to the women's individual needs, addressing issues like depression, anxiety, trauma, and substance use. Treatment as Usual (TAU) - Women in this group will receive basic information on PrEP, mental health, and harm reduction, along with optional referrals to PrEP or drug treatment clinics. The study will evaluate feasibility of administering MI-PrEP and CETA+MI-PrEP and how well these interventions help women start and stay on PrEP, as well as the intervention's impact on mental health and drug use. Researchers will also interview participants and counselors to understand the participants and counselors experiences with the program. The goal is to find effective ways to support PrEP use among women who use drugs and to develop a model that could be used in similar settings to reduce HIV risk. This pilot study is approved by ethics committees in the United States and Tanzania, and results will be shared with communities, policymakers, and researchers.

Nen ŨnkUmbi/EdaHiYedo Plus (We Are Here Now Plus): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth

We Are Here Now - Plus (NE+) is a holistic, culturally centered, and multilevel intervention for American Indian youth to improve sexual health, mental health, and substance use outcomes. The goal of this intervention is to learn if NE+ can decrease substance use during sex, decrease sexual activity, increase condom use, increase positive mental health, increase caregiver(parent)-youth communication, increase communication between school personnel and youth, and increase utilization of clinical services. Researchers will compare one intervention arm to one control arm to see if the aforementioned indicators improve among the intervention arm for youth participants. Youth participants (ages 12-18) will participate in a 9-month educational program consisting of 18 modules that discuss healthy relationships, puberty \& physiology (separate girls \& boys), parenting, pregnancy and sexually transmitted infections (STIs) and Human Immunodeficiency Virus (HIV) prevention, sexual avoidant behaviors with a focus on abstinence, substance use prevention with a focus on abstinence and refusal skills, \& positive mental health, resources; skills (high school)- self-efficacy, refusal skills, decision making, communication, abstinence; skills (middle school) - health knowledge, self-efficacy, boundaries, communication, abstinence. Youth will also participate in six teachings offered by local cultural leaders that coincide with educational modules, including: kinship networks \& family; cultural values; 7 sacred roles of tribal members; ceremonies; cultural teachings and responsibilities of women \& men in tribe \& ceremonies; Indigenous worldview; skills - knowledge of traditional ways, language \& cultural people to go to for help; community members roles \& responsibilities in tribe \& ceremonies. Caregiver (parent) participants will participate in three in-person visits/meetings to discuss the following: visit 1 - age specific physical, cognitive, emotional, spiritual development; visit 2: prevention of substance use, promoting positive mental health, promotion of healthy relationships; skills -communication with youth; visit 3 - pregnancy and STIs/HIV prevention and abstinence from sex, parental monitoring, tribal resources. School personnel participants will participate in three workshops during teacher in-service training days, including the following information: Workshop 1 - cultural teachings on kinship \& family networks, cultural values, cultural age \& community roles; Workshop 2 - sexual risk avoidant behaviors, substance use prevention, positive mental health promotion, pregnancy STIs/HIV prevention, tribal resources; Workshop 3 - culturally respectful communication skills by age \& youth (boy/girl) and age \& caregiver (male/female); skills - knowledge of cultural ways, substance use prevention, positive mental health promotion, sexual risk avoidant behaviors, culturally respectful communication.

Research and Evaluation of Link-Up, DCR in Brussels

Link-Up is the second Safer Consumption Room (SCMR) to open in the Brussels-Capital Region. SCMRs are public health facilities designed for people who use drugs mainly in public places. They are hygienically safe spaces where users can safely consume the products they have acquired elsewhere without moral judgment, under the supervision of specially trained professional staff. It is a risk reduction facility. Before Link-Up, two other SCMRs were opened in Belgium, including one, GATE, in the Brussels region. These first two SCMRs are currently undergoing scientific evaluation as part of the REVE-DROOM project (approved by the CEHF (2024/28MAI/276, on 06/18/2024) of the "Drugs" research program funded by BELSPO (Federal Science Policy). The present project aims to replicate the study of the effects associated with the use of SCMRs on users, as implemented in the evaluation system currently underway at GATE in the new SCMR, Link-Up, with a view to also evaluating its effects. The RELINK study is being conducted at the request of Iriscare, the bicommunal social protection OIP (Public Interests Organization) of the Brussels-Capital Region. It is a study based on a natural experiment (i.e., all Link-Up users who agree to participate in the study will be included) and measures various indicators concerning them. The measured indicators primarily concern risky consumption practices (injection, consumption in public spaces, reuse and/or sharing of consumption equipment, and other practices that endanger the health of people who use drugs). As secondary effects, the measures concern the sociodemographic and socioeconomic characteristics of the user population, drug-use profiles, level of social integration, quality of life, level of personal recovery, and care needs. The analysis of these various indicators will make it possible to describe the profile of Link-up SCS users and to compare it with that of GATE users. In addition, the study design allows for an extension to conduct a cohort follow-up and, therefore, to measure changes associated with the use of the SCS service. The current study aims for a sample of at least 250 people recruited within the service. Indicator measurement is carried out using a questionnaire administered with the assistance of the research team and supported by SCS staff. The questionnaire consists of various scales validated in the scientific literature and already used in the REVE-DROOM study. Given the similarity of the proposed Link-Up system with the one implemented at GATE, the results of the two Brussels SCSs will be the subject of a comparative analysis.

Adaptation of the Family Check-Up Online

Latinx people are the largest and fastest growing minority population in the U.S., yet most lack access to community responsive preventative interventions to reduce substance use among youth. Effective implementation of evidence-based interventions that can be delivered online is critical to reduce substance use and problem behaviors among ethnic populations and to scale up for broad dissemination. Adaptation to address community needs has improved parenting practices and youth outcomes beyond the original evidence-based parenting interventions, and adapted parenting programs have the potential to improve cultural socialization, which is associated with improved behavioral outcomes among Latinx youth. However, ongoing tensions in the field highlight the question of whether deep adaptations compared to surface-level adaptations (e.g., translation only) are needed. The FCU is an evidence-based parenting program that has a strong history of reducing substance abuse and externalizing symptoms (e.g., problem behaviors). A community-based participatory approach will be employed to culturally adapt the FCU Online and identify implementation strategies to improve access to and adoption of the intervention, leveraging community and resiliency-promoting assets. Promotores de salud, Spanish-speaking community health workers in an existing community-based research network will deliver the program. To reach the goals of the study, the following aims will guide this research. In Aim 1, a community advisory board of 6 parents and 6 promotores de salud will meet monthly to guide the ecological adaptation of the FCU Online modules and implementation strategies with promotores. In Aim 2, the online version of the intervention will be adapted using iterative Plan-Do-Study-Act cycles to get usability feedback from members of the community advisory board, consistent with best practices designed to adapt interventions in community settings. In Aim 3, using a Hybrid 1, mixed methods design, researchers will assess feasibility, accessibility, adoption, and potential effectiveness of the adapted intervention, FCU-L Online. The team will recruit 108 Latinx families into a 3-arm wait-list randomized control trial: n=36 in the culturally adapted FCU-L Online (e.g., deep adaptation), n=36 in the FCU Online in Spanish without adaptation (e.g., surface level adaptation), and n= 36 in a waitlist control group. Feasibility, accessibility, and adoption will be assessed according to quantitative benchmarks, and qualitative feedback will assess the barriers and facilitators of implementation. Potential effectiveness will be assessed (p \< .15), including improvement of key intervention mechanisms (parenting practices, parenting efficacy, and cultural socialization) as well as child outcomes (substance use, intentions to use, and externalizing behavior). Findings from this study will inform a Hybrid II randomized controlled implementation trial to test effectiveness while scaling up dissemination of the FCU-L Online. This research could ultimately reduce lifetime risk for substance use among Latinx youth by improving parenting practices and supporting cultural socialization.

The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study

The goal of this clinical trial is to develop and test the CROSSROADS intervention. CROSSROADS is designed for people who have recently survived an opioid and/or stimulant-related non-fatal overdose and had contact with staff from a Community Paramedic (CP) program. Participants will be randomly placed into one of two groups: 1\) Standard of care from the CP program, or 2) CROSSROADS, which includes CP care plus a Medical-Legal Partnership (MLP). The MLP helps people with legal problems that can affect their health-- like issues with housing or public benefits. Researchers will test if the CROSSROADS intervention reduces drug use and involvement with the criminal legal system. People in the study will be followed for one year and asked to complete surveys at the beginning, and again at 1 month, 6 months, and 12 months.

VR Mindfulness for People With HIV and Substance Use

The goal of this clinical trial is to explore whether a virtual reality (VR) mindfulness app is acceptable, appropriate, and feasible for supporting people with HIV and substance use problems. Participants will: * Use a VR headset with a mindfulness app at home; * Complete three online surveys over three months; * Take part in an individual interview or focus group to share their experiences.

Options for Navigating Talking About Risk and Adolescent Choices

This study will examine the effectiveness of ON-TRAC (Options for Navigating Talking about Risk and Adolescent Choices), which is an online substance use prevention program that also teaches emotion regulation skills. 200 adolescents, 12-15 years of age, will be randomized to ON-TRAC or a wait list comparison group (who will be offered the intervention at the end of their study participation) to determine impact on substance use, emotion regulation abilities, mental health symptoms, and other risk behavior outcomes.

Understanding Psychological Distress and Therapeutic Environment in the Emergency Department

This research aims to establish the number of patients coming to Emergency Departments (EDs) with issues relating to mental health, alcohol or drugs, or in some form of psychological distress, including those for whom this was not the main reason for attending ED. We will collect anonymous information on age, gender, ethnicity, when and how they came to the ED, where and how they are cared for whilst in the ED, and what happens to them afterwards. With this information we hope to build a better picture of these patients so we can go on to design and test ways to improve their care in the future.