Tele-Harm Reduction (T-SHARP)

May 18, 2026 updated by: Hansel Tookes, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • Care Resource The SPOT
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33612
        • University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tele-Harm Reduction (THR)
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.
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.
Active Comparator: off-site linkage to HIV care
introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic
Other: off-site linkage
standard of care linkage to a Ryan White clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral suppression
Time Frame: up to 12 months
HIV viral load <200 copies/ml time-averaged
up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Hansel Tookes, MD, MPH, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Actual)

January 16, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201516
  • DP2DA053720 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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