Tele-Harm Reduction

Not Applicable

Active, not recruiting

• Conditions: IV Drug Usage; Hepatitis C; HIV Infections
• Interventions: Behavioral: Tele-Harm Reduction; Other: off-site linkage

• Registration Number: NCT05208697
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-10-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-Harm Reduction (THR)	Tele-Harm Reduction	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	off-site linkage	introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic

Primary Outcome Measures

Name	Time	Method
Viral suppression	up to 12 months	HIV viral load \<200 copies/ml time-averaged

Secondary Outcome Measures

Name	Time	Method
HCV cure	up to 12 months	HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion
Initiation of medications for opioid use disorder	up to 12 months	Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed.

Trial Locations

Locations (6)

Care Resource The SPOT; 🇺🇸 Fort Lauderdale, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Care Resource The SPOT; 🇺🇸 Fort Lauderdale, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States