INSPIRE Initiative for HIV Prevention

(INSPIRE Trial)

Not yet recruiting at 2 trial locations
SL
JC
Overseen ByJiepin Cao
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to refine and test a new approach to prevent HIV among Chinese immigrant female sex workers (FSWs) working in massage parlors in Queens, NYC. Researchers seek to determine if this new support method is both practical and welcomed by the community. Participants will be divided into two groups: one receiving the intervention (the INSPIRE Initiative) and the other serving as a comparison. Women who are at least 18 years old, identify as Chinese, and have worked in a massage parlor providing sexual services in the past year may be eligible, provided they haven't had an HIV test in the last three months or know they are HIV-positive. The trial will also include interviews and focus groups to gather more insights from participants and community members. As an unphased trial, this study offers participants the opportunity to contribute to innovative community health solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for Chinese immigrant FSWs?

Research has shown that the INSPIRE Initiative is being tested to determine its effectiveness in preventing HIV. Although specific safety data for this initiative is not yet available, the trial remains in its early stages. Researchers are still assessing how well participants tolerate the intervention.

As a pilot trial, the primary focus is on evaluating the intervention's practicality and acceptability. This means that any potential risks are under careful scrutiny. So far, no public data from past studies has indicated serious side effects from similar interventions. Participants can expect researchers to closely monitor safety throughout the study.12345

Why are researchers excited about this trial?

Researchers are excited about the INSPIRE Initiative for HIV Prevention because it targets a specific at-risk group, female sex workers, offering a potentially more tailored approach to HIV prevention. Unlike traditional prevention methods like pre-exposure prophylaxis (PrEP) pills, which require daily adherence, the INSPIRE Initiative may incorporate innovative strategies that fit better with the lifestyles and needs of these women. This initiative is also expected to address the social and environmental factors that increase risk, offering a more comprehensive prevention strategy. By focusing on this unique population and integrating a broader range of protective measures, the initiative holds promise for significantly reducing new HIV infections within this vulnerable group.

What evidence suggests that the INSPIRE Initiative could be effective for HIV prevention?

Research shows that the INSPIRE Initiative focuses on preventing HIV among Chinese immigrant women who work as sex workers in Queens, NYC. Participants in this trial will be randomized into two groups: the Intervention Group, which will receive the INSPIRE Initiative intervention, and the Control Group. Although specific data on its effectiveness for this group is limited, similar programs have aimed to improve health and prevent HIV. The initiative employs both group and one-on-one methods to change behavior, which have been tested in other contexts. For instance, past studies have used these methods with HIV-positive individuals, helping them remain in care and modify their behavior, though results have varied. While specific outcomes of this trial are still being assessed, the approach is based on proven prevention methods.14567

Who Is on the Research Team?

SL

Sahnah Lim, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for Chinese immigrant female sex workers (FSWs) in Queens, NYC. It aims to improve their well-being and HIV prevention strategies by addressing stigma. To participate, individuals must be part of this community and work in massage parlors.

Inclusion Criteria

I am a female Chinese massage parlor worker in Queens, over 18, and have provided sexual services in the last year.
I am over 18 and serve the immigrant Chinese women community.
I am a Chinese woman who has worked as a sex worker and I speak both Mandarin and English.
See 1 more

Exclusion Criteria

I am over 18 and do not speak English or Mandarin.
Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).
I am a CAB member who is either under 18 or does not speak English.
See 1 more

Timeline for a Trial Participant

Development

Community-driven process to refine a preliminary intervention design based on previous research

Intervention

Pilot randomized controlled trial of the multi-level intervention with 70 Chinese immigrant FSWs

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • INSPIRE Initiative
Trial Overview The INSPIRE Initiative is being tested against the standard care given to FSWs. The study involves refining an intervention through community input, then piloting it with participants randomly assigned to either the new initiative or standard care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

INSPIRE Initiative for HIV Prevention · Info for ParticipantsThis trial is for Chinese immigrant female sex workers (FSWs) in Queens, NYC. It aims to improve their well-being and HIV prevention strategies by addressing ...
JAIDS Journal of Acquired Immune Deficiency SyndromesCONCLUSION. The INSPIRE study tested a theory-based group- and individual-level behavioral intervention for HIV-positive IDUs and found no evidence of ...
Project INSPIRE < Infectious Diseases - Yale School of MedicinePrimary outcomes for this study were retention in HIV care, time to relapse to alcohol use, and acceptability of medication assisted therapy.
RePORT ⟩ RePORTERWe're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.
Merck to Initiate Phase 3 Trials for Investigational Once ...The EXPrESSIVE-11 (MK-8527-011, NCT 07044297) trial will evaluate the safety and efficacy of MK-8527 among people with greater likelihood of HIV ...
Project DetailsThis project will measure both the risks and benefits of using this technology for HIV prevention research and then gauge the acceptability of these approaches ...
INSPIRE Intervention Model | Download Scientific DiagramThe HIV prevention cascade is understudied among sex workers in Jamaica, where sex work and same sex practices are criminalized. We implemented a cross- ...
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