- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Prima fase 1
Contatti e Sedi
Luoghi di studio
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02904
- Rhode Island Hospital
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Contatto:
- Lindsay Orchowski, PhD
- Numero di telefono: 401-444-7021
- Email: lindsay_orchowski@brown.edu
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Contatto:
- Prachi Bhuptani, PhD
- Email: prachi_bhuptani@brown.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
- Age 18 years and above at enrollment
- Woman
- Screen positive for lifetime sexual trafficking
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Control Group
Wait List Control
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment engagement
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Alcohol Use
Lasso di tempo: Assessed at baseline and 2-month follow-up
|
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
Lasso di tempo: 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
|
|
HIV Risk Behavior
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Satisfaction with Program
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1R34DA063037-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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