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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study includes finalization of the LINKED social network intervention to improve PrEP and MOUD uptake among people who inject drugs (PWID) in collaboration with an Expert Advisory Board and staff (N=16) at The Sidewalk Project (TSP), followed by a Hybrid Type II cluster randomized trial of the LINKED intervention (versus an equal-attention control) among N=372 people who inject drugs, with 6- and 12-month follow-up assessment of PrEP and MOUD uptake. The investigators will also evaluate implementation outcomes to inform future sustainable implementation of LINKED in harm reduction organizations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LINKED Intervention | Experimental | Participants randomized to the LINKED arm will receive a peer change agent intervention consisting of a 3-hour workshop divided into four learning and practice modules. |
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| Equal-Attention Control | Active Comparator | Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINKED | Behavioral | LINKED is a theory-driven social network intervention (SNI) that leverages peer influence within the social networks of people who inject drugs (PWID) to disseminate information, encourage communication, and increase pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD) uptake and persistence in harm reduction organization (HRO) settings. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with PrEP Uptake | Measured via filled PrEP prescription. | Month 6 |
| Percentage of Participants with PrEP Uptake | Measured via filled PrEP prescription. | Month 12 |
| Percentage of Participants with MOUD Uptake | Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment. | Month 6 |
| Percentage of Participants with MOUD Uptake | Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment. | Month 12 |
| Percentage of Participants with PrEP Adherence | Measured via urine immunoassays to test for oral PrEP. | Month 6 |
| Percentage of Participants with PrEP Adherence | Measured via urine immunoassays to test for oral PrEP. | Month 12 |
| Percentage of Participants with MOUD Adherence | Measured via urinalysis to test for metabolites for MOUD. | Month 6 |
| Percentage of Participants with MOUD Adherence | Measured via urinalysis to test for metabolites for MOUD. |
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Inclusion Criteria:
Aim 1 - Virtual Focus Group
Aim 2 - Intervention
Aim 3 - Virtual Focus Group/Surveys
Exclusion Criteria:
Aims 1 and 3:
• Individuals who are not current TSP staff members will be excluded from participation.
Aim 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzan Walters, PhD | Contact | 951-443-6351 | Suzan.Walters@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Suzan Walters, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Suzan.Walters@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Suzan.Walters@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Group Intervention | Behavioral | Group intervention facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose. |
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| Month 12 |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| NYU Langone Health | New York | New York | 10016 | United States |
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