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临床试验/NCT07699484
NCT07699484尚未招募早期 1 期

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

Lifespan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年10月5日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
发起方
Lifespan
入组人数
60
试验地点
1
主要终点
Treatment engagement

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years and above at enrollment
  • Screen positive for lifetime sexual trafficking

排除标准

  • 未提供

研究组 & 干预措施

CONNECT Program: Screening

Experimental

Screening, intervention, referral, care navigation

干预措施: CONNECT (Behavioral)

Control Group

No Intervention

Wait List Control

结局指标

主要结局

Treatment engagement

时间窗: 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)

Treatment Utilization

时间窗: 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.

次要结局

  • Alcohol Use(Assessed at baseline and 2-month follow-up)
  • Drug Use(Assessed at baseline and 2-month follow-up)
  • HIV Risk Behavior(Assessed at baseline and 2-month follow-up)
  • PTSD Symptoms(Assessed at baseline and 2-month follow-up)
  • Overall Health Symptoms (Depression)(Assessed at baseline and 2-month follow-up)
  • Anxiety Symptoms(Assessed as change from baseline to 2-months)

研究者

发起方
Lifespan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsay Orchowski Ph.D.

Professor

Rhode Island Hospital

研究点 (1)

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