HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking

NCT07264582 | Not Yet Recruiting

• 2 other identifiers: AAAV83511R34DA063049
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

This project will assess whether a digital survivor crowdsourced intervention can increase HIV/STI/HCV testing and overdose prevention kit utilization among survivors of sex trafficking living in New York City. Survivors of sex trafficking have among the highest rates of HIV/STIs/HCV and substance use disorder (SUD), yet they face substantial barriers to care, including lack of information about care and financial and logistical constraints. In addition, there is a lack of public health messaging tailored specifically for survivors of sex trafficking to meet their needs. Citizen science approaches, such as crowdsourcing (i.e., engaging groups of individuals to address public health challenges and share solutions), are scalable, cost-effective tools that can increase HIV/SUD prevention and treatment utilization. Crowdsourcing can be used to engage survivors in developing tailored messaging to promote HIV/STI/HCV testing, overdose prevention, and treatment utilization. Complementing crowdsourcing, specimen self-collection with remote HIV/STI/HCV testing and online delivery of overdose prevention kits to survivors may also increase use of needed healthcare services. Study aims are: 1) develop crowdsourced digital messages to promote HIV/STI/HCV testing uptake and utilization of overdose prevention services for substance use among sex trafficking survivors; 2) in a randomized controlled trial, to compare the survivor-crowdsourced HIV and substance use intervention to existing public health messaging among sex trafficking survivors (n=368) in New York City; and 3) assess the contribution of multi-level factors on reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) outcomes. This work will result in a digital crowdsourced intervention to increase HIV/STI/HCV testing uptake, overdose prevention kit utilization, and linkage to care among survivors of sex trafficking. This project will also result in a crowdsourcing and messaging toolkit that can be broadly distributed to public health and other agencies across the country for their use in designing messaging campaigns for survivors. Findings from this project will lay the groundwork for citizen science-developed HIV and SUD interventions for sex trafficking survivors across the US.

Conditions

STI; HCV; Overdose, Drug; HIV Testing

Keywords

HIV; STI; HCV; overdose prevention; crowdsourcing; citizen science

Outcome Measures

Primary Outcomes (2)

• HIV/STI/HCV testing uptake

  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

  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 Outcomes (4)

• Linkage to HIV/STI/HCV care

  From baseline to the 6-month follow-up

• Linkage to substance use services

  From baseline to the 6 month follow-up

• HIV/STI stigma

  Baseline, 3 months, and 6 months

• Substance use stigma

  Baseline, 3 months, and 6 months

Study Arms (2)

Crowdsourced Messaging Intervention

EXPERIMENTAL

The digital crowdsourced intervention will be presented to participants in the intervention arm.

Behavioral: Sex Trafficking Survivor-Developed Digital Crowdsourced Intervention

Standard of Care

NO INTERVENTION

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.

Interventions

Sex Trafficking Survivor-Developed Digital Crowdsourced Intervention BEHAVIORAL

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.

Crowdsourced Messaging Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• Not willing to provide consent or not able to understand study procedures

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Drug Overdose

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Alissa Davis, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alissa Davis, PhD

CONTACT

212-851-2224; ad3324@columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to receive the digital crowdsourced messaging materials or existing HIV/STI/HCV testing and overdose prevention materials. The investigators will examine the effects of the intervention on increasing HIV/STI/HCV testing and increasing utilization of overdose prevention kits.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 4, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Final submission and release of the study data will occur within 12 months following publication of the main outcomes paper and will be available through the National Addiction and HIV Data Archive Program (NAHDAP) repository in perpetuity.
• Access Criteria: Data will be deposited as a restricted use dataset in NAHDAP. Investigators interested in analyzing the data must submit a request to NAHDAP and receive approval before they will be able to access the data.

Locations

US (1)