NCT05208697

Tele-Harm Reduction

Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
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.
OTHER	off-site linkage	standard of care linkage to a Ryan White clinic

Timeline

• Start date: 2022-10-10
• Primary completion: 2026-01-16
• Completion: 2026-04-30
• First posted: 2022-01-26
• Last updated: 2026-02-03

Locations

3 sites across 1 country: United States