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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH136914-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Female Sex Workers (FSWs) randomized to receive the intervention. |
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| Control Group | Active Comparator | Female Sex Workers (FSWs) randomized to the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Completed HIV Testing | Assessed via self-report. | Follow-Up Visit 1 (Approximately Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with PrEP Uptake | Assessed via self-report; percentage of participants who begin PrEP treatment. | Follow-Up Visit 1 (Approximately Week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sahnah Lim, PhD | Contact | 917-214-9070 | Sahnah.lim@nyulangone.org | |
| Jiepin Cao | Contact | 919-717-7093 | Jiepin.cao@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Sahnah Lim, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
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.
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.
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| Standard of Care | Behavioral | Standard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates. |
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| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| CUNY-Hunter College | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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