Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-10-10
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tele-Harm Reduction (THR)
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.
Tele-Harm Reduction
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.
off-site linkage to HIV care
introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic
off-site linkage
standard of care linkage to a Ryan White clinic
Interventions
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Tele-Harm Reduction
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.
off-site linkage
standard of care linkage to a Ryan White clinic
Eligibility Criteria
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Inclusion Criteria
* able to speak English
* enrolled in IDEA Miami or IDEA Tampa SSPs
* injection drug use in past 12 months by self-report
* willing and able to sign informed consent, provide locator information and medical records release
* testing reactive for HIV by rapid test
* HIV RNA\>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date)
Exclusion Criteria
* receipt of THR intervention in the past 6 months
* inability to provide informed consent
* planning to leave the area within 12 months
* Principal or site investigator discretion
* currently in prison or jail
* Enrollment in Clinical Trials Network 121
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Miami
OTHER
Responsible Party
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Hansel Tookes
Associate Professor
Principal Investigators
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Hansel Tookes, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Care Resource The SPOT
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Countries
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References
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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.
Other Identifiers
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20201516
Identifier Type: -
Identifier Source: org_study_id
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