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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA058352 | 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 ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Tele-harm Reduction | Experimental | Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months. |
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| Off-site Linkage to HIV prevention | Active Comparator | Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Tele-harm Reduction | Behavioral | Comprehensive Tele-Harm Reduction is on-demand services including low-barrier access to PrEP, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, peer harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an syringe services program. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV prevention via pre-exposure prophylaxis (PrEP) | Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction | up to 12 months |
| HIV prevention via medications for opioid use disorder | Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| syringe coverage | Number of syringes distributed/(number of injections per day x days between exchanges) | up to 12 months |
| PrEP Adherence | TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hansel Tookes, MD | Contact | 3052431615 | hetookes@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hansel Tookes, MD | University of Miami | Principal Investigator |
| Tyler Bartholomew, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDEA Miami | Recruiting | Miami | Florida | 33136 | United States | |
| IDEA Syringe Services Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38528570 | Derived | Bartholomew TS, Plesons M, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, Chueng TA, Ciraldo K, Brooks J, Smith JD, Barocas JA, Tookes HE. Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services. Addict Sci Clin Pract. 2024 Mar 25;19(1):21. doi: 10.1186/s13722-024-00447-9. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Off-site Linkage to HIV Prevention | Behavioral | The community engagement team is comprised of peers and social workers and provides the wraparound support needed.The team will assist participants in scheduling appointments at community health clinics. The community engagement team provides active clinic referral- that is, a member of the team will accompany patients to the first clinic visit. |
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| up to 12 months |
| Engagement in HCV treatment | Direct acting antiviral prescription confirmed on electronic health record abstraction | Up to 12 months |
| HCV cure | Negative HCV RNA viral load at least 12 weeks post treatment completion | up to 12 months |
| treatment of sexually transmitted infections | Medical records show prescription of appropriate antibiotics | up to 12 months |
| time to harm | Time to: (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose | up to 12 months |
| number of harms | Count of (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose | up to 12 months |
| Not yet recruiting |
| Miami |
| Florida |
| 33136 |
| United States |
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| 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 |