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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

No Placebo-Only Group

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a total hip replacement in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met