← Back to Search

NA

Tele-Harm Reduction for Intravenous Drug Use (T-SHARP Trial)

N/A
Recruiting
Led By Hansel Tookes, MD, MPH
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Be older than 18 years old
Must not have
Receipt of THR intervention in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This trial will test two ways of offering HIV, HCV, and addiction medications to people who inject drugs.

Who is the study for?
This trial is for adults over 18 who use intravenous drugs and are enrolled in specific Substance Use Support Programs in Miami or Tampa. Participants must have HIV with a certain viral load, may also have Hepatitis C, be willing to consent to the study, and not plan to move away within a year. Those already receiving similar interventions or unable to consent are excluded.
What is being tested?
The study compares two methods of delivering treatments for HIV, potentially curing Hepatitis C, and addressing substance use disorder among drug users. One method involves 'Tele-Harm Reduction' while the other uses 'off-site linkage' to connect participants with care services.
What are the potential side effects?
While specific side effects aren't listed here as it depends on individual treatments for HIV, Hepatitis C, and substance use disorders; these can range from medication reactions like nausea or rash to more serious issues related to liver health or infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a total hip replacement in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Viral suppression
Secondary study objectives
HCV cure
Initiation of medications for opioid use disorder

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tele-Harm Reduction (THR)Experimental Treatment1 Intervention
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.
Group II: off-site linkage to HIV careActive Control1 Intervention
introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
935 Previous Clinical Trials
421,977 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,136 Total Patients Enrolled
Hansel Tookes, MD, MPHPrincipal InvestigatorUniversity of Miami

Media Library

Tele-Harm Reduction (NA) Clinical Trial Eligibility Overview. Trial Name: NCT05208697 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: Tele-Harm Reduction (THR), off-site linkage to HIV care
Human Immunodeficiency Virus Infection Clinical Trial 2023: Tele-Harm Reduction Highlights & Side Effects. Trial Name: NCT05208697 — N/A
Tele-Harm Reduction (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05208697 — N/A
~56 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top