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Not yet recruiting NCT07103525

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

No phase Interventional HIV Prevention Wellbeing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INSPIRE Initiative, Standard of Care.
Who it may be relevant to
Registry conditions: HIV Prevention, Wellbeing. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Behavioral INSPIRE Initiative
    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.
  • Behavioral Standard of Care
    Standard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates.

Primary outcome measures

  • Percentage of Participants who Completed HIV Testing [Time frame: Follow-Up Visit 1 (Approximately Week 6)]
Secondary outcome measures (1)
  • Percentage of Participants with PrEP Uptake [Time frame: Follow-Up Visit 1 (Approximately Week 6)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • NYU Langone Health — New York
  • Columbia University Irving Medical Center — New York
  • CUNY-Hunter College — New York

Identifiers

NCT: NCT07103525 · 24-01572 · R34MH136914-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗