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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLifespan

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 volunteers

Qualifiers

Age 18 years and above at enrollment

Woman

Screen positive for lifetime sexual trafficking

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CONNECT Program: ScreeningExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Measured at baseline and at 2-month follow-up
2

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.

Time frame
Total session attendance measured at baseline and at 2-month follow-up

Secondary outcomes

1

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.

Time frame
Assessed at baseline and 2-month follow-up
2

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.

Time frame
Assessed at baseline and 2-month follow-up
3

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)

Time frame
Assessed at baseline and 2-month follow-up
4

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.

Time frame
Assessed at baseline and 2-month follow-up

Other outcomes

1

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.

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

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: