- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07699484
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02904
- Rhode Island Hospital
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Kontakt:
- Lindsay Orchowski, PhD
- Telefonnummer: 401-444-7021
- E-mail: lindsay_orchowski@brown.edu
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Kontakt:
- Prachi Bhuptani, PhD
- E-mail: prachi_bhuptani@brown.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
- Age 18 years and above at enrollment
- Woman
- Screen positive for lifetime sexual trafficking
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: CONNECT Program: Screening
Screening, intervention, referral, care navigation
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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.
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Ingen indgriben: Control Group
Wait List Control
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment engagement
Tidsramme: Measured at baseline and at 2-month follow-up
|
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)
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Measured at baseline and at 2-month follow-up
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Treatment Utilization
Tidsramme: Total session attendance measured at baseline and at 2-month follow-up
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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.
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Total session attendance measured at baseline and at 2-month follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcohol Use
Tidsramme: Assessed at baseline and 2-month follow-up
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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.
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Assessed at baseline and 2-month follow-up
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Drug Use
Tidsramme: Assessed at baseline and 2-month follow-up
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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.
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Assessed at baseline and 2-month follow-up
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|
HIV Risk Behavior
Tidsramme: Assessed at baseline and 2-month follow-up
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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)
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Assessed at baseline and 2-month follow-up
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PTSD Symptoms
Tidsramme: Assessed at baseline and 2-month follow-up
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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.
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Assessed at baseline and 2-month follow-up
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Overall Health Symptoms (Depression)
Tidsramme: Assessed at baseline and 2-month follow-up
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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.
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Assessed at baseline and 2-month follow-up
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Anxiety Symptoms
Tidsramme: Assessed as change from baseline to 2-months
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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.
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Assessed as change from baseline to 2-months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Satisfaction with Program
Tidsramme: Assessed immediate post program as a descriptive measure (no comparison group)
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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.
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Assessed immediate post program as a descriptive measure (no comparison group)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R34DA063037-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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