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
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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Rhode Island
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Providence、Rhode Island、アメリカ、02904
- Rhode Island Hospital
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コンタクト:
- Lindsay Orchowski, PhD
- 電話番号:401-444-7021
- メール:lindsay_orchowski@brown.edu
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コンタクト:
- Prachi Bhuptani, PhD
- メール:prachi_bhuptani@brown.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
- Age 18 years and above at enrollment
- Woman
- Screen positive for lifetime sexual trafficking
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ふるい分け
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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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介入なし:Control Group
Wait List Control
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment engagement
時間枠: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
時間枠:Total session attendance measured at baseline and at 2-month follow-up
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Alcohol Use
時間枠: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
時間枠:Assessed at baseline and 2-month follow-up
|
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
時間枠: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
時間枠: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)
時間枠:Assessed at baseline and 2-month follow-up
|
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
時間枠: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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Satisfaction with Program
時間枠: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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1R34DA063037-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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