About this trial
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/STI, 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:
Does 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?
Researchers 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.
Participants will:
Complete the CONNECT program or receive usual care Work 1:1 with a care navigator who helps with referrals to substance use, HIV/STI, 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and above at enrollment
Woman
Screen positive for lifetime sexual trafficking
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
CONNECT
BehavioralCONNECT intervention provides screening for sex trafficking with the goal of increasing treatment engagement for substance use, HIV/STI, and psychological distress among victims of sex trafficking.
Treatment groups
Trial outcomes
Primary outcomes
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 \[self-report / record review\]. This is a binary variable (yes/no), with the positive outcome being "yes" (treatment initiated)
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.
Secondary outcomes
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.
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.
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)
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.
Other outcomes
Satisfaction with Program
Client Satisfaction Questionnaire - 8 will assess overall satisfaction with the intervention, scored from 8 to 32, with higher scores indicating greater satisfaction. Assessed after each session.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lifespan
Lead sponsor
Rhode Island Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: