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
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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Rhode Island
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Providence、Rhode Island、美国、02904
- Rhode Island Hospital
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接触:
- Lindsay Orchowski, PhD
- 电话号码:401-444-7021
- 邮箱:lindsay_orchowski@brown.edu
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接触:
- Prachi Bhuptani, PhD
- 邮箱:prachi_bhuptani@brown.edu
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
- Age 18 years and above at enrollment
- Woman
- Screen positive for lifetime sexual trafficking
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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无干预:Control Group
Wait List Control
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment engagement
大体时间:Measured at baseline and at 2-month follow-up
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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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Alcohol Use
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction with Program
大体时间: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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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1R34DA063037-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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