HIV TestingNCT07264582
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
A study testing Sex Trafficking Survivor-Developed Digital Crowdsourced Intervention in people with HIV Testing and STI, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Testing, STI, HCV
- What is being tested?
- Sex Trafficking Survivor-Developed Digital Crowdsourced Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Who cannot join
- Not willing to provide consent or not able to understand study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University
New York, New York, 10027
Alissa Davis, PhD, 212-851-2224, ad3324@columbia.edu
About this study
Official title: 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
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.
Read the 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.
- Conditions
- HIV Testing, STI, HCV, Overdose, Drug
- Being tested
- Sex Trafficking Survivor-Developed Digital Crowdsourced Intervention
- Keywords
- HIV, STI, HCV, overdose prevention, crowdsourcing, citizen science
- Medical subject headings
- Sexually Transmitted Diseases, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sex Trafficking Survivor-Developed Digital Crowdsourced InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Crowdsourced Messaging Intervention | Experimental | The digital crowdsourced intervention will be presented to participants in the intervention arm. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From baseline to the 6 month follow-up
Secondary outcomes (4)
Linkage to HIV/STI/HCV care
The number of participants who test positive for HIV/STI/HCV and who access care. It is a dichotomous outcome (yes/no).
Measured: From baseline to the 6-month follow-up
Linkage to substance use services
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).
Measured: From baseline to the 6 month follow-up
HIV/STI stigma
Mean score change in stigma from baseline to 3 months follow-up and 6 months follow-up. Higher scores correspond to higher stigma levels.
Measured: Baseline, 3 months, and 6 months
Substance use stigma
Mean score change in stigma from baseline to 3 months follow-up and 6-months follow-up. Higher scores correspond to higher stigma levels.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV TestingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alissa Davis, Columbia University
- Investigators
- Alissa Davis, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264582
- Sponsor's protocol ID
- AAAV8351
- Other IDs
- 1R34DA063049
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Survey data from baseline and follow-up assessments will be preserved and deposited in the National Addiction and HIV Data Archive Program (NAHDAP) repository.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07264582
- Acronym / sponsor ID
- AAAV8351
- Conditions
- HIV Testing, STI, HCV, Overdose, Drug
- Keywords
- HIV, STI, HCV, overdose prevention, crowdsourcing, citizen science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Crowdsourced Messaging Intervention | Experimental | Behavioral: Sex Trafficking Survivor-Developed Digital Crowdsourced InterventionThe digital crowdsourced intervention will be presented to participants in the intervention arm. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to provide consent or not able to understand study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sex Trafficking Survivor-Developed Digital Crowdsourced InterventionSurvivors 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. | Behavioural | Crowdsourced Messaging Intervention |
Primary outcome
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).
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).
4 secondary outcomes
Linkage to HIV/STI/HCV care
Time frame: From baseline to the 6-month follow-up
Linkage to substance use services
Time frame: From baseline to the 6 month follow-up
HIV/STI stigma
Time frame: Baseline, 3 months, and 6 months
Substance use stigma
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. Survey data from baseline and follow-up assessments will be preserved and deposited in the National Addiction and HIV Data Archive Program (NAHDAP) repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alissa Davis, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sex Trafficking Survivor-Developed Digital Crowdsourced Intervention in people with HIV Testing and STI, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alissa Davis, PhD (212-851-2224, ad3324@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV/STI/HCV testing uptake (time frame: From baseline to the 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.