Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sex Trafficking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CONNECT.
- Who it may be relevant to
- Registry conditions: Sex Trafficking, HIV, Substance Use (Drugs, Alcohol), Mental Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sexual Trafficking
Overview
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
Detailed description
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.
Interventions
- Behavioral CONNECT
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.
Primary outcome measures
- Treatment engagement [Time frame: Measured at baseline and at 2-month follow-up]
- Treatment Utilization [Time frame: Total session attendance measured at baseline and at 2-month follow-up]
Secondary outcome measures (6)
- Alcohol Use [Time frame: Assessed at baseline and 2-month follow-up]
- Drug Use [Time frame: Assessed at baseline and 2-month follow-up]
- HIV Risk Behavior [Time frame: Assessed at baseline and 2-month follow-up]
- PTSD Symptoms [Time frame: Assessed at baseline and 2-month follow-up]
- Overall Health Symptoms (Depression) [Time frame: Assessed at baseline and 2-month follow-up]
- Anxiety Symptoms [Time frame: Assessed as change from baseline to 2-months]
Eligibility criteria
- Age 18 years and above at enrollment
- Woman
- Screen positive for lifetime sexual trafficking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Screening
Study locations
United States · 1 center
- Rhode Island Hospital — Providence
Identifiers
NCT: NCT07699484 · 1R34DA063037-01