AzTrials
AzTrials

Sex TraffickingEarly Phase 1NCT07699484

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

A Early Phase 1 study testing CONNECT in people with Sex Trafficking and HIV, run by Lifespan at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
CONNECT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Oct 2026to 30 Jun 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  1. Age 18 years and above at enrollment
  2. Woman
  3. Screen positive for lifetime sexual trafficking

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Rhode Island Hospital

    Providence, Rhode Island, 02904

    Lindsay Orchowski, PhD, 401-444-7021, lindsay_orchowski@brown.edu

    Prachi Bhuptani, PhD, prachi_bhuptani@brown.edu

Other trials in United States

About this study

Official title: 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?

Read more

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

Read the 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.

Being tested
CONNECT
Keywords
Sex Trafficking, HIV, Substance Use, Mental Health, Sexual Violence, Treatment Engagement
Medical subject headings
Substance-Related Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CONNECTBehavioural

    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.

Study groups in NCT07699484
Study groupRoleWhat they receive
CONNECT Program: ScreeningExperimentalScreening, intervention, referral, care navigation
Receives: Behavioral: CONNECT
Control GroupNo interventionWait List Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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.

    Measured: Total session attendance measured at baseline and at 2-month follow-up

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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)

    Measured: 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.

    Measured: Assessed at baseline and 2-month follow-up

  5. 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.

    Measured: Assessed at baseline and 2-month follow-up

  6. 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.

    Measured: Assessed as change from baseline to 2-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start5 Oct 2026 (estimated)
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699484
Sponsor's protocol ID
1R34DA063037-01
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will follow data sharing plans as required by NIDA and specified in the data management and sharing plan.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CONNECT in people with Sex Trafficking and HIV, run by Lifespan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment engagement (time frame: Measured at baseline and at 2-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07699484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in