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| ID | Type | Description | Link |
|---|---|---|---|
| DP2DA053720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-Harm Reduction (THR) | Experimental | THR utilizes 2 components. Component 1: telehealth technology facilitated by a peer harm reduction counselor to connect the participant with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program (ADAP). Component 2: utilizes the syringe services program (SSP)-based peer harm reduction counselor to work with participants in identifying individual-specific barriers and facilitators to medication adherence. |
|
| off-site linkage to HIV care | Active Comparator | introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Harm Reduction | Behavioral | THR is telehealth-enhanced, on-demand services including low-barrier access to antiretrovirals, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an SSP, integrated with the provision of evidence-based naloxone and injection equipment. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral suppression | HIV viral load <200 copies/ml time-averaged | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of medications for opioid use disorder | Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed. | up to 12 months |
| HCV cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hansel Tookes, MD, MPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Resource The SPOT | Fort Lauderdale | Florida | 33311 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36750867 | Derived | Tookes HE, Oxner A, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, McCollister K, Rodriguez A, Kolber MA, Chueng TA, Zayas S, McCoy B, Sutherland K, Archer C, Bartholomew TS. Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs. Trials. 2023 Feb 7;24(1):96. doi: 10.1186/s13063-023-07074-w. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2026 | Jun 26, 2026 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| off-site linkage | Other | standard of care linkage to a Ryan White clinic |
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HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion
| up to 12 months |
| Miami |
| Florida |
| 33136 |
| United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |