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

NYU Langone Health

Status: Not yet enrolling

Conditions: Wellbeing; HIV Prevention

Treatments: Behavioral: INSPIRE Initiative; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07103525

R34MH136914-01A1 (U.S. NIH Grant/Contract)

24-01572

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: INSPIRE Initiative

Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard of Care