- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264582
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
A Citizen Science Approach to Increase HIV/STI/HCV Testing and Substance Use Service Utilization Among Survivors of Sex Trafficking Living in New York City
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators propose to develop and assess whether a digital survivor-crowdsourced (i.e., engaging individuals to address public health challenges and share solutions) intervention can increase testing for HIV, sexually transmitted infections (STIs), and hepatitis C virus (HCV) and the utilization of life-saving overdose prevention practices and services among survivors of sex trafficking (ST) in New York City (NYC). ST survivors have higher risk substance use (e.g., injection drug use, fentanyl) than women who are not trafficked -- >84% have used substances, with ~33% experiencing forced substance use, and ~70% a drug overdose. ST survivors have higher HIV/STI prevalence rates (up to 70%) than even non-trafficked women in sex work. Nearly 50% of survivors have branding tattoos, increasing their risk for HCV. Despite their elevated rates of HIV/STIs/HCV and substance use disorder (SUD), there is a lack of public health messaging tailored specifically for ST survivors, and much of the existing messaging is denigrating toward this population. Survivors also face substantial barriers to care, including lack of information about care access and logistical constraints. In the absence of innovative interventions tailored for this population, health problems among ST survivors will persist.
The Study's Specific Aims are:
Aim 1: Develop crowdsourced digital messages to promote HIV/STI/HCV testing uptake and utilization of overdose prevention services for substance use among female ST survivors. To achieve this aim, in partnership with our Citizen Collaborative Research Board (CCRB), the investigators will use in-depth interviews and conduct a series of designathons, launched via a national crowdsourcing open call, in which survivors ideate, prototype and present multimedia content to promote HIV/STI/HCV testing uptake and utilization of overdose prevention services among peers.
Aim 2: In a randomized controlled trial, to compare the survivor-crowdsourced HIV and substance use intervention to existing public health messaging among ST survivors (n=368) in New York City.
Hypothesis: The crowdsourced intervention will increase HIV/STI/HCV testing uptake and utilization of overdose prevention services among survivors compared to control content. The primary outcome will be online HIV/STI/HCV tests completed and online ordering of overdose prevention kits. Secondary outcomes will be linkage to HIV/STI/HCV care, PrEP, and substance use disorder (SUD) services.
Aim 3: Assess the contribution of multi-level factors on reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) outcomes. The investigators will use the PRISM framework and a mixed methods approach to assess RE-AIM outcomes via qualitative interviews, surveys, and HIV/STI/HCV testing and overdose prevention kit referral vouchers.
Hypothesis: HIV/STI/HCV testing and overdose prevention kit referral and uptake will be significantly greater among the crowdsourced intervention arm than among the control arm.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alissa Davis, PhD
- Phone Number: 212-851-2224
- Email: ad3324@columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Columbia University
-
Contact:
- Alissa Davis, PhD
- Phone Number: 212-851-2224
- Email: ad3324@columbia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older
- Born biologically female or identify as a woman
- Living in New York City
- Used illicit substances within the past 12 months or has a history of substance use dependency
- Would feel safe participating in the study
- Is a survivor of sex trafficking as defined by the following criteria: 1) Has the individual ever had sex for things of value? If 'Yes', then the individual must also answer 'Yes' to the following question, 2) Was the individual pressured or forced by another person to do this?
Exclusion Criteria:
- Not willing to provide consent or not able to understand study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Crowdsourced Messaging Intervention
The digital crowdsourced intervention will be presented to participants in the intervention arm.
|
Survivors of sex trafficking will participate in crowdsourcing contests to create digital materials to promote HIV/STI/HCV testing and use of overdose prevention kits.
Entries will be judged by community and expert judges.
Top entries will be selected for the digital intervention and presented to participants in the intervention arm.
|
|
No Intervention: Standard of Care
Standard informational materials about HIV/STI/HCV testing and overdose prevention currently used by Departments of Health and other health organizations will be presented to participants in the control arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV/STI/HCV testing uptake
Time Frame: From baseline to the 6 month follow-up
|
The number of participants who ordered and returned a HIV/STI/HCV test kit from baseline to the 6-month follow-up.
It is a dichotomous outcome (yes/no).
|
From baseline to the 6 month follow-up
|
|
Overdose Prevention Kit Uptake
Time Frame: From baseline to the 6 month follow-up
|
The number of participants who ordered an overdose prevention kit from baseline to the 6-month follow-up.
It is a dichotomous outcome (yes/no).
|
From baseline to the 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Linkage to HIV/STI/HCV care
Time Frame: From baseline to the 6-month follow-up
|
The number of participants who test positive for HIV/STI/HCV and who access care.
It is a dichotomous outcome (yes/no).
|
From baseline to the 6-month follow-up
|
|
Linkage to substance use services
Time Frame: From baseline to the 6 month follow-up
|
The number of participants who use substances who accessed substance use services from baseline to the 6-month follow-up.
It is a dichotomous outcome (yes/no).
|
From baseline to the 6 month follow-up
|
|
HIV/STI stigma
Time Frame: Baseline, 3 months, and 6 months
|
Mean score change in stigma from baseline to 3 months follow-up and 6 months follow-up.
Higher scores correspond to higher stigma levels.
|
Baseline, 3 months, and 6 months
|
|
Substance use stigma
Time Frame: Baseline, 3 months, and 6 months
|
Mean score change in stigma from baseline to 3 months follow-up and 6-months follow-up.
Higher scores correspond to higher stigma levels.
|
Baseline, 3 months, and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alissa Davis, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Drug Misuse
- Mental Disorders
- Pathologic Processes
- Disease Attributes
- Infections
- Communicable Diseases
- Substance-Related Disorders
- Chemically-Induced Disorders
- Prescription Drug Misuse
- Pathological Conditions, Signs and Symptoms
- Sexually Transmitted Diseases
- Drug Overdose
Other Study ID Numbers
- AAAV8351
- 1R34DA063049 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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