Clinical Research Directory

Cultural Adaptation of Drug Treatment for DJJ Youth

This project aims to improve the understanding of the impact of Ethnic and Racial Discrimination (ERD) on adolescent alcohol and other drug use (AOD) within the Black Justice-Involved Youth (JIY) population. Individual interviews with Black JIY and focus groups with parents and guardians of Black JIY and community members who support change and reform in the justice community for Black JIY will be conducted.

Harm Reduction in HIV Primary Care for PLWH Who Use Drugs

People living with HIV (PLWH) who use drugs experience significant health disparities including lower rates of retention in HIV care and higher rates of unsuppressed viral load, resulting in secondary infections and increased mortality. The proposed study will used mixed methods to explore (a) the relationship between healthcare providers' attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational harm reduction; (b) the degree to which relational harm reduction moderates the effect of intersectional stigma experienced in healthcare settings on patients' perceptions of their relationship with providers; (c) the degree to which structural HR moderates the relationship between the patient-provider relationship and clinical outcomes, and (d) whether patient-perceived HR approaches to care are directly associated with HIV clinical outcomes. The study will also use these findings to inform the development and pre-testing of an intervention to operationalize harm reduction in HIV clinical settings, using stakeholder-engaged and human-centered design approaches, presenting a novel path to reducing HIV health inequities for PLWH who use drugs.

Testing and Evaluation of the Returning to the Land Intervention to Address and Prevent Substance Misuse

This study aims to test the Returning to the Land intervention in partnership with a tribal community. The program is designed to address caregiver substance use and child emotional and behavioral development.

CBITS-RTM Pilot Study

This pilot study, conducted in partnership with juvenile detention centers, evaluates an adapted CBITS-RTM intervention delivered in a detention school setting.

Recovery Finance: Financial Health and Mental Health After Incarceration

This proposal will address financial wellbeing, an often overlooked but important factor impacting reentry for justice-involved people with mental health challenges, who are disproportionately Black and Latine. The project will change community level determinants by integrating financial capability support (one-on-one coaching and access to financial tools and services) into existing services and training bank and credit union staff to reduce discrimination. It will also support collaborative community efforts working towards upstream policy and legal reforms to reduce the incidence of those financial challenges.

Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors

The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital. During a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm. Primary Objective: \- Assess the feasibility and acceptability of integrating a standardized substance use screening and brief intervention protocol into routine psychosocial workflows within a survivorship clinic. Secondary Objective: \- Evaluate the fidelity of delivering a brief substance use intervention to reduce substance use behaviors among survivors.

Neuroimaging of Adolescent Cannabis Use Treatment

This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.

Finding Emotional Empowerment and Lifelong Strength

This study will build a partnership with a Community Advisory Board to co-produce, and then pilot test, a theory-guided mental health literacy intervention focused on trauma and substance use. Participants will take part in educational group sessions for 12 weeks and complete assessments at baseline and two follow-up time points (mid-intervention and post-intervention). Intervention participants will be randomly invited to post-study focus groups to gather feedback on their experiences in the program.

Neurobehavioral Signatures of Sign- and Goal-Tracking in Emerging Adults: Translation of a Preclinical Model

This study seeks to understand individual differences in personality, brain function, and behavior. Study hypothesis: \- A stronger sign-tracking bias will be associated with a bottom-up processing style characterized by less adaptive attentional- and impulse-control as well as hyperactive reward processing, whereas a stronger goal-tracking bias will be associated with a top-down processing style characterized by strong attentional- and impulse-control as well as normative reward processing.

Adaptation and Evaluation of Bright Horizons

This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents. Bright Horizons is a culturally adapted intervention developed and tested through a partnership between The White Mountain Apache Tribe and Johns Hopkins University. Bright Horizons is a brief intervention that teaches emotion regulation, coping skills, and problem solving. The intervention also uses goal setting to reduce alcohol and other substance use and to connect to individuals with treatment.

Community Driven Substance Use Recovery for High Opioid Overdose Areas

The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities of color.

The Development and Evaluation of a Culturally Grounded ENDS Intervention for Rural Hawaiian Youth

The purpose of this research proposal is to develop and evaluate a culturally grounded, ENDS prevention intervention for rural Hawaiian youth. This will be accomplished through two specific aims. AIM 1 (Years 1-3) are focused on pre-intervention and intervention development. In Year 1, youth focus groups will be conducted to assess the environmental demands related to ENDS use in rural Hawai'i. In Year 2, specific ENDS-related problem situations (i.e., situations that increase risk for ENDS use) will be extracted from the Year 1 focus groups and prioritized through survey methods with 200-250 predominately Native Hawaiian youth across 16 different middle/intermediate schools on Hawai'i Island. In Year 3, five situations found to be the most frequently experienced and/or difficult to manage by youth surveyed in Year 2 will serve as the foundation for the development of narrative scripts. Three of these scripts will be cast and filmed on location on Hawai'i Island by a professional film director, and will be edited into three short films, 6-8 video clips, and 6-8 professional photos or production stills. Similar to the investigators' prior drug prevention research in rural Hawai'i, classroom-based lessons will be created to support the short films. Additional lessons and videos from an evidence-based, culturally grounded substance abuse prevention curriculum for Hawaiian youth (Ho'ouna Pono) will be used to create a modular classroom curriculum. The video clips and professional photography/production stills will be embedded with prevention messaging, and will be used for a social and print media campaign to reinforce the classroom curriculum. AIM 2 (Years 4-5) is to evaluate the ENDS prevention intervention (classroom curriculum plus social/print media campaign) across all middle/intermediate public or public-charter schools (N = 16) and up to 11 different cultural immersion charter schools on Hawai'i Island using a dynamic wait-listed control group design.

Leveraging Social Networks to Increase COVID-19 Testing Uptake

This two-year project will adapt and conduct a trial examining the ability of two recruitment strategies, chain-referral and credible messenger, to reach those who use opioids and other substances in order to increase their uptake of onsite point of care COVID-19 testing that will be delivered in two community based organizations (CBOs): Alliance for Positive Change and Argus Health Inc. In Phase 1, Adapt two implementation strategies to support COVID-19 testing uptake and sustainability, adapting elements of existing efficacious social network-based interventions via a CBPR approach. In Phase 2, we will examine and compare the efficacy of two sets of implementation strategies on (i) reach, (ii) testing uptake, (iii) service delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for individuals who use opioids and other drugs. In Phase 3, Elucidate and compare the system/organizational-, staff-, and individual-level factors that influence implementation (i.e. fidelity, acceptability, feasibility, sustainability) of the strategies to develop a plan for dissemination and scale-up in other CBOs who serve opioid and other substance using individuals in NYC.

Maternal Brain Imaging in Opioid Use Disorder

This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.

mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System

This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools. The study will: * Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services. * Refine and test the updated program to make sure it works well and is easy to use. * Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services. The overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.

Project REACH: A Comprehensive Telehealth Intervention at Syringe Service Programs to Engage People Who Use Drugs

This trial will assess the feasibility, acceptability, and preliminary effectiveness of Project REACH (Remote Engagement \& Access for Community Health), a telehealth intervention at syringe service programs (SSP) to improve access to HIV-related evidence-based interventions (EBI) for people who use drugs including those who inject them.

The Collaborative Care PrTNER Study

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29 through engagement in SU treatment.

The Hastiin Bidziil (Strong Man) Intervention

The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18 years and older

A Novel Intervention for Patients With Cancer

This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories The names of the study intervention and research activities involved in this study are/is: * Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist) * Questionnaires * Post-study interview Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.

Intervention for Virologic Suppression in Youth

The goal of this randomized clinical trial is to test the effect of a technology-based intervention with an Adaptive Treatment Strategy (ATS) among youth living with HIV (YLWH) (18-29 years old). This piloted and protocolized intervention combines: (1) brief weekly sessions with a counselor via a video-chat platform (video-counseling) to discuss mental health (MH), substance use (SU), HIV care engagement, and other barriers to care; and (2) a mobile health application (app) to address barriers such as ART forgetfulness and social isolation. Individuals who are not virologically suppressed will be randomized to video-counseling+app or standard of care (SOC). Through this study, the investigators will be able to: Aim 1: Test the efficacy of video-counseling+app vs SOC on virologic suppression in YLWH.The investigators will compare HIV virologic suppression of those randomized to the intervention vs control arms at 16 weeks via an RCT. Aim 2: Assess the impact of video-counseling+app vs SOC on MH and SU in YLWH. The investigators will evaluate the MH and SU differences between the intervention vs control arms at 16 weeks via an RCT. Aim 3: Explore an ATS to individualize the intervention by assigning the: 1. virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks, 2. virologic "responders" in the intervention arm to continue only app use for 16 more weeks. Researchers will compare the characteristics of virologic responders and non-responders to the intervention, individualization of the intervention based on these variables, and linkage to MH and SU treatment services among those in need to see if delivery of care is enhanced and impact on virologic suppression.

Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting. This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.

Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa

The purpose of this study is to evaluate a stepped care behavioral intervention for HIV medication adherence and substance use ("Khanya") integrated into an HIV primary care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors with lived substance use experience (i.e., peers), using a task sharing, stepped care model in local primary care clinics. The Khanya stepped care package will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months.

Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)

The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use.

Permanent Supportive Housing Overdose Prevention+ Study

This community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based practices to prevent tenant overdose and improve tenant health.