Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma

NCT07103525 | Not Yet Recruiting DMC

• 2 other identifiers: 24-01572R34MH136914-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Completed HIV Testing

  Assessed via self-report.

  Follow-Up Visit 1 (Approximately Week 6)

Secondary Outcomes (1)

• Percentage of Participants with PrEP Uptake

  Follow-Up Visit 1 (Approximately Week 6)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Female Sex Workers (FSWs) randomized to receive the intervention.

Behavioral: INSPIRE Initiative

Control Group

ACTIVE COMPARATOR

Female Sex Workers (FSWs) randomized to the control group.

Behavioral: Standard of Care

Interventions

INSPIRE Initiative BEHAVIORAL

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.

Intervention Group

Standard of Care BEHAVIORAL

Standard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

CUNY-Hunter College

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sahnah Lim, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahnah Lim, PhD

CONTACT

917-214-9070; Sahnah.lim@nyulangone.org

Jiepin Cao

CONTACT

919-717-7093; Jiepin.cao@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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. We 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.

Locations

US (3)