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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

T-SHARP Trial 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.Check my eligibility

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.See study design

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.

T-SHARP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

T-SHARP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Viral suppression

Secondary outcome measures

HCV cure

Initiation of medications for opioid use disorder

T-SHARP 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

900 Previous Clinical Trials

409,692 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,108 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enroll in this research endeavor at the present time?

"Affirmative. Clinicaltrials.gov shows that this clinical study is still looking for participants, which was initially posted on October 7th 2022 and most recently amended the same day. This investigation requires 240 individuals to be recruited from 2 medical centres."

Answered by AI

To what extent is participation being observed in this experiment?

"Affirmative. The research study is currently in the process of recruiting patients, with an initial posting date on October 7th 2022 and a recent update on that same day. 240 individuals must be enrolled from two distinct medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tele-Harm Reduction

Hansel Tookes 2022. "Tele-Harm Reduction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208697.

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