[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07699484":3,"trial-entities:NCT07699484":105,"trial-summary:NCT07699484":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":50,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":79,"locations":82,"central_contacts":101,"overall_officials":102,"references":103,"see_also_links":104},"NCT07699484","1R34DA063037-01","Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sex Trafficking","Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sexual Trafficking","NOT_YET_RECRUITING","2028-06-30","2026-07","2026-07-13","2026-10-05","Lifespan","OTHER",true,"The goal of this clinical trial is to learn if the CONNECT program helps women with a history of sex trafficking get connected to substance use, HIV\u002FSTI, and mental health services. It will also learn whether the program is practical to deliver and acceptable to participants. The main questions it aims to answer are:\n\nDoes CONNECT increase participants' engagement in substance use treatment (such as starting medication for opioid use disorder or therapy for alcohol use), HIV and STI prevention and treatment services (such as starting PrEP or getting tested for STIs), and mental health treatment (such as treatment for PTSD)? Is CONNECT feasible and acceptable for women with a history of sex trafficking?\n\nResearchers will compare CONNECT to usual care to see if CONNECT increases engagement in these health services. The program will be delivered in partnership with a Street Medicine team that provides care directly to unhoused women, with support from a trained care navigator.\n\nParticipants will:\n\nComplete the CONNECT program or receive usual care Work 1:1 with a care navigator who helps with referrals to substance use, HIV\u002FSTI, and mental health services (CONNECT group) Complete assessments at the start of the study and at a 2-month follow-up Answer questions about their substance use, health behaviors, mental health, and use of health services","Consistent with the goals of RFA-DA-25-018 Engaging Survivors of Sexual Violence and Trafficking in HIV and Substance Use Disorder Services, the objective of this R34 application is to develop and evaluate the CONNECT program for use in a sample of women with a history of sex trafficking to evaluate its feasibility, acceptability, and preliminary efficacy. CONNECT will be delivered in collaboration with the Street Medicine team, which provides health and social services directly to unhoused women in their own environment; who are at high risk for sex trafficking. CONNECT will also be administered with the support of a trained care navigator to provide 1:1 assistance in completing CONNECT and navigating referrals to substance use, HIV\u002FSTI, and mental health care. Following (ADAPT-ITT) framework and informed by a Community-Based Participatory Research approach, information from informant interviews (N = 9), focus groups (N = 30), stakeholder interviews (N = 6), and the Community Advisory Board will be leveraged to adapt the intervention. An open trial (N = 12) with a 2-month follow-up will be conducted to demonstrate program feasibility, acceptability, satisfaction, and utility of CONNECT. A randomized pilot trial (N = 60) with a 2-month follow-up will be conducted to examine whether women randomized to CONNECT, relative to control, show change in: treatment engagement outcomes for substance use (e.g., MOUD initiation, therapy for alcohol use), HIV and STI treatment\u002Fprevention services (e.g., uptake of PrEP, testing for STI), and\u002For mental health treatment (e.g., treatment for PTSD). Secondary outcomes of domains relating to motivation to seek treatment aligned with the theory of planned behavior (i.e., attitudes, intentions, self-efficacy, subjective norms, and stigma will be explored. Behavioral outcomes of changes in substance use outcomes (e.g., reduced substance use), HIV and STI risk behaviors, and mental health outcomes (e.g., improvements in PTSD) will also be examined. Mediators (i.e., readiness to change) and moderators (i.e., trauma history) will be examined (exploratory). To prepare for Hybrid Type I efficacy trial, exit interviews will be conducted with participants (N = 20), and practitioners (N = 9) to describe contextual factors that might influence subsequent implementation.",[19,20,21,22,23,24],"Sex Trafficking","HIV","Substance Use (Drugs, Alcohol)","Mental Health","Sexual Violence","Treatment Engagement",[19,20,26,22,23,24],"Substance Use","INTERVENTIONAL","SCREENING",[30],"EARLY_PHASE1",{"count":32,"type":33},60,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","CONNECT","CONNECT intervention provides screening for sex trafficking with the goal of increasing treatment engagement for substance use, HIV\u002FSTI, and psychological distress among victims of sex trafficking.",[40],"CONNECT Program: Screening",[42,46],{"measure":43,"description":44,"timeFrame":45},"Treatment engagement","Number of Participants Who Initiate Substance Use or Mental Health Treatment Description: Treatment initiation, defined as attending at least one treatment appointment, verified by \\[self-report \u002F record review\\]. This is a binary variable (yes\u002Fno), with the positive outcome being \"yes\" (treatment initiated)","Measured at baseline and at 2-month follow-up",{"measure":47,"description":48,"timeFrame":49},"Treatment Utilization","Number of Treatment Sessions Attended (Treatment Utilization) \\[self-report and record review). This is a count variable, with the positive outcome being a greater number of sessions attended.","Total session attendance measured at baseline and at 2-month follow-up",[51,55,58,61,64,67],{"measure":52,"description":53,"timeFrame":54},"Alcohol Use","Change From Baseline in Alcohol Use Disorders Identification Test (AUDIT) Score at 2 Months. Scores range from 0 to 40; higher scores indicate more hazardous alcohol use.","Assessed at baseline and 2-month follow-up",{"measure":56,"description":57,"timeFrame":54},"Drug Use","Change From Baseline in Drug Use Disorders Identification Test (DUDIT) Score at 2 Months. Scores range from 0 to 44; higher scores indicate more problematic drug use.",{"measure":59,"description":60,"timeFrame":54},"HIV Risk Behavior","Change From Baseline in HIV Risk Behavior Scale Score at 2 Months (Darke et al., 1990; HIV Risk-taking Behavior Scale ranges 0-55; higher scores indicate greater HIV risk behavior)",{"measure":62,"description":63,"timeFrame":54},"PTSD Symptoms","Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score at 2 Months; Scores range from 17 to 85; higher scores indicate greater PTSD symptom severity.",{"measure":65,"description":66,"timeFrame":54},"Overall Health Symptoms (Depression)","Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) to score at 2 Months, scores range from 0 to 27; higher scores indicate more severe depressive symptoms.",{"measure":68,"description":69,"timeFrame":70},"Anxiety Symptoms","Change From Baseline to 2-months in Generalized Anxiety Disorder-7 (GAD-7), Scores range from 0 to 21; higher scores indicate more severe anxiety symptoms.","Assessed as change from baseline to 2-months","FEMALE","18 Years",null,false,{"inclusion":76,"exclusion":77,"raw_text":78},[],[],"1. Age 18 years and above at enrollment\n2. Woman\n3. Screen positive for lifetime sexual trafficking",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"Rhode Island Hospital","Providence","Rhode Island","02904","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Lindsay Orchowski, PhD","CONTACT","401-444-7021","lindsay_orchowski@brown.edu",{"name":96,"role":92,"email":97},"Prachi Bhuptani, PhD","prachi_bhuptani@brown.edu",{"lat":99,"lon":100},41.82399,-71.41283,[],[],[],[],{"nct_id":4,"conditions":106,"biomarkers":110},[107,108,19,23,109],"HIV Infection","Psychiatric Disorder","Substance use disorder",[],{"nct_id":4,"found":15,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study, meaning participants will receive the CONNECT program. It plans to enroll 60 women.","completed","CONNECT Program for Survivors of Sex Trafficking","This study is testing a program called CONNECT to see if it helps women who have experienced sex trafficking get connected to important health services. These services include treatment for substance use (like drugs or alcohol), HIV\u002FSTI (sexually transmitted infection) prevention and treatment, and mental health support. Researchers want to know if CONNECT helps you engage in these treatments, such as starting medication for opioid use disorder or therapy for PTSD (Post-Traumatic Stress Disorder). They also want to see if the program is practical to deliver and if participants find it helpful. The study is looking for women aged 18 and older who have a history of sex trafficking. The goal is to see if CONNECT increases your involvement in these care options, with outcomes measured at the start and after two months.","Participants will be followed for two months after starting the program to measure treatment engagement and utilization.",133,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]