HIV, Mental Health, Sex Trafficking, Sexual Violence, Substance Use (Drugs, Alcohol), Treatment Engagement
Conditions
Keywords
Sex Trafficking, HIV, Substance Use, Mental Health, Sexual Violence, Treatment Engagement
Brief summary
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
BEHAVIORALCONNECT
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.
Sponsors
Lifespan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and above at enrollment 2. Woman 3. Screen positive for lifetime sexual trafficking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment engagement | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | 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. |
| Drug Use | 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. |
| HIV Risk Behavior | Assessed at baseline and 2-month follow-up | 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) |
| PTSD Symptoms | Assessed at baseline and 2-month follow-up | 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. |
| Overall Health Symptoms (Depression) | 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. |
| Anxiety Symptoms | Assessed as change from baseline to 2-months | 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. |
Countries
United States
Outcome results
None listed