Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sex Trafficking

NCT07699484 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 1R34DA063037-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sex Trafficking; HIV; Substance Use (Drugs, Alcohol); Mental Health; Sexual Violence; Treatment Engagement

Keywords

Sex Trafficking; HIV; Substance Use; Mental Health; Sexual Violence; Treatment Engagement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Alcohol Use

  Assessed at baseline and 2-month follow-up

• Drug Use

  Assessed at baseline and 2-month follow-up

• HIV Risk Behavior

  Assessed at baseline and 2-month follow-up

• PTSD Symptoms

  Assessed at baseline and 2-month follow-up

• Overall Health Symptoms (Depression)

  Assessed at baseline and 2-month follow-up

Other Outcomes (1)

• Satisfaction with Program

  Assessed immediate post program as a descriptive measure (no comparison group)

Study Arms (2)

CONNECT Program: Screening

EXPERIMENTAL

Screening, intervention, referral, care navigation

Behavioral: CONNECT

Control Group

NO INTERVENTION

Wait List Control

Interventions

CONNECT BEHAVIORAL

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.

CONNECT Program: Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Materials will be shared as available at the completion of the study.
• Access Criteria: Data will be publicly available, and interested parties can contact the PI for support in accessing data.

Locations

US (1)