HIV PreventionINSPIRENCT07103525
Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma
A study testing INSPIRE Initiative in people with HIV Prevention and Wellbeing, run by NYU Langone Health at 3 sites in United States.
Trial summary
During the development phase (Aim 1), investigators will use a community-driven process to further refine a preliminary intervention design that was developed based on previous research. For the intervention phase (Aim 2), investigators will conduct a pilot randomized controlled trial of the multi-level intervention. 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 Prevention, Wellbeing
- What is being tested?
- INSPIRE Initiative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2026to Jan 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
- Female Sex Workers: A person who identifies as a woman, Chinese, a massage parlor (MP) worker in Queens, who is at least 18 years old, and has provided sexual services in the past 12 months, will be eligible.
- Community advisory board (CAB) members: self identifies as a community member providing services to immigrant Chinese women and is at least 18 years old.
- Peer Advocates: self identifies as current or previous sex worker, is a Chinese adult woman, and speaks both Mandarin and English.
- Medical Providers: self identifies as a current medical provider who works with Chinese immigrant adults and speaks English.
Who cannot join
- Female Sex Workers: Because completion of HIV testing is our primary study outcome, women who received an HIV test in the previous 3 months or who know they are HIV-positive will be excluded from the study.
- Community advisory board (CAB) members: Does not speak English or is under the age of 18.
- Peer Advocates: Does not speak English/Mandarin or is under the age of 18.
- Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
NYU Langone Health
New York, New York, 10016
Sahnah Lim, PhD
Columbia University Irving Medical Center
New York, New York, 10032
Chiaying Wei, PhD
CUNY-Hunter College
New York, New York, 10065
John Chin, PhD
About this study
Official title: INSPIRE: Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma
During the development phase (Aim 1), investigators will use a community-driven process to further refine a preliminary intervention design that was developed based on previous research.
For the intervention phase (Aim 2), investigators will conduct a pilot randomized controlled trial of the multi-level intervention. For the individual-level component of the intervention, investigators will recruit 70 Chinese immigrant FSWs who work in MPs in Queens, NYC (n=35 intervention participants and n=35 control participants).
To assess the feasibility and acceptability of intervention implementation (Aim 3), investigators will conduct in-depth qualitative interviews with 12 FSW study participants and the 2 peer advocates and focus groups with 4-5 staff from each of the 3 organizations (3 focus groups total and 12-15 focus group participants in total).
- Conditions
- HIV Prevention, Wellbeing
- Being tested
- INSPIRE Initiative, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIRE InitiativeBehavioural
Culturally relevant, multi-level intervention designed to increase HIV testing through reducing intersectional stigma. Intervention includes series of four one-on-one conversations (45 minutes each over a six-week period) via mobile phone between the Hunter peer advocates and FSWs, which are reinforced through weekly text messages from the peer advocates and through role-model stories shared online.
Standard of CareBehavioural
Standard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Female Sex Workers (FSWs) randomized to receive the intervention. Receives: Behavioral: INSPIRE Initiative |
| Control Group | Active comparator | Female Sex Workers (FSWs) randomized to the control group. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Completed HIV Testing
Assessed via self-report.
Measured: Follow-Up Visit 1 (Approximately Week 6)
Secondary outcomes (1)
Percentage of Participants with PrEP Uptake
Assessed via self-report; percentage of participants who begin PrEP treatment.
Measured: Follow-Up Visit 1 (Approximately Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startJun 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sahnah Lim, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103525
- Sponsor's protocol ID
- 24-01572
- Other IDs
- R34MH136914-01A1
- Acronym
- INSPIRE
- Status last verified
- May 2026
- First submitted
- 29 Jul 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, will be shared. The study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be shared. All data will be deposited to the NIMH Data Archive (NDA) starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates. Anyone who wishes to access the data for any purpose will be granted access. The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. Investigators will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRE: Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma
- ClinicalTrials.gov ID
- NCT07103525
- Acronym / sponsor ID
- INSPIRE / 24-01572
- Conditions
- HIV Prevention, Wellbeing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Aug 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.
During the development phase (Aim 1), investigators will use a community-driven process to further refine a preliminary intervention design that was developed based on previous research.
For the intervention phase (Aim 2), investigators will conduct a pilot randomized controlled trial of the multi-level intervention. For the individual-level component of the intervention, investigators will recruit 70 Chinese immigrant FSWs who work in MPs in Queens, NYC (n=35 intervention participants and n=35 control participants).
To assess the feasibility and acceptability of intervention implementation (Aim 3), investigators will conduct in-depth qualitative interviews with 12 FSW study participants and the 2 peer advocates and focus groups with 4-5 staff from each of the 3 organizations (3 focus groups total and 12-15 focus group participants in total).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: INSPIRE InitiativeFemale Sex Workers (FSWs) randomized to receive the intervention. |
| Control Group | Active comparator | Behavioral: Standard of CareFemale Sex Workers (FSWs) randomized to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Sex Workers: A person who identifies as a woman, Chinese, a massage parlor (MP) worker in Queens, who is at least 18 years old, and has provided sexual services in the past 12 months, will be eligible.
- Community advisory board (CAB) members: self identifies as a community member providing services to immigrant Chinese women and is at least 18 years old.
- Peer Advocates: self identifies as current or previous sex worker, is a Chinese adult woman, and speaks both Mandarin and English.
- Medical Providers: self identifies as a current medical provider who works with Chinese immigrant adults and speaks English.
Key exclusion criteria (4 listed)
- Female Sex Workers: Because completion of HIV testing is our primary study outcome, women who received an HIV test in the previous 3 months or who know they are HIV-positive will be excluded from the study.
- Community advisory board (CAB) members: Does not speak English or is under the age of 18.
- Peer Advocates: Does not speak English/Mandarin or is under the age of 18.
- Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).
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 |
|---|---|---|
| INSPIRE InitiativeCulturally relevant, multi-level intervention designed to increase HIV testing through reducing intersectional stigma. Intervention includes series of four one-on-one conversations (45 minutes each over a six-week period) via mobile phone between the Hunter peer advocates and FSWs, which are reinforced through weekly text messages from the peer advocates and through role-model stories shared online. | Behavioural | Intervention Group |
| Standard of CareStandard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates. | Behavioural | Control Group |
Primary outcome
Percentage of Participants who Completed HIV Testing
Time frame: Follow-Up Visit 1 (Approximately Week 6)
Assessed via self-report.
1 secondary outcome
Percentage of Participants with PrEP Uptake
Time frame: Follow-Up Visit 1 (Approximately Week 6)
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 29 May 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be shared. The study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be shared. All data will be deposited to the NIMH Data Archive (NDA) starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates. Anyone who wishes to access the data for any purpose will be granted access. The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. Investigators will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
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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.
Sahnah Lim, PhD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSPIRE Initiative in people with HIV Prevention and Wellbeing, run by NYU Langone Health at 3 sites 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 4 inclusion and 4 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Sahnah Lim, PhD (917-214-9070, Sahnah.lim@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Completed HIV Testing (time frame: Follow-Up Visit 1 (Approximately Week 6)). 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 29 May 2026.