Tele-Harm Reduction

Purpose

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.

Conditions

  • IV Drug Usage
  • HIV Infections
  • Hepatitis C

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age 18 or older - 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

  • testing HIV negative via rapid test - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: 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.
Active Comparator
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
  • Other: off-site linkage
    standard of care linkage to a Ryan White clinic

Recruiting Locations

More Details

NCT ID
NCT05208697
Status
Active, not recruiting
Sponsor
University of Miami

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center