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

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

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Mental Health; Sexual Violence; Treatment Engagement; Sex Trafficking; Substance Use (Drugs, Alcohol)
• Intervention / Treatment: Behavioral: CONNECT

Detailed Description

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/STI, 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/prevention services (e.g., uptake of PrEP, testing for STI), and/or 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Rhode Island Hospital
      • Contact: Lindsay Orchowski, PhD; Phone Number: 401-444-7021; Email: lindsay_orchowski@brown.edu
      • Contact: Prachi Bhuptani, PhD; Email: prachi_bhuptani@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Age 18 years and above at enrollment
2. Woman
3. Screen positive for lifetime sexual trafficking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CONNECT Program: Screening; Screening, intervention, referral, care navigation	Behavioral: CONNECT; CONNECT 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.
No Intervention: Control Group; Wait List Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Measured at baseline and at 2-month follow-up
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Assessed at baseline and 2-month follow-up
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)	Assessed at baseline and 2-month follow-up
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.	Assessed at baseline and 2-month follow-up
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.	Assessed at baseline and 2-month follow-up
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed immediate post program as a descriptive measure (no comparison group)

Collaborators and Investigators

• Sponsor: Lifespan

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; HIV; Substance Use; Treatment Engagement; Sexual Violence; Sex Trafficking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Personal Satisfaction; Substance-Related Disorders; Psychological Well-Being
• Other Study ID Numbers: 1R34DA063037-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will follow data sharing plans as required by NIDA and specified in the data management and sharing plan.
• IPD Sharing Time Frame: Materials will be shared as available at the completion of the study.
• IPD Sharing Access Criteria: Data will be publicly available, and interested parties can contact the PI for support in accessing data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No