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OpenTrials
Completed

NCT Number: NCT05208697

Tele-Harm Reduction

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.

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Key information

Conditions

IV Drug Usage Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Care Resource The SPOT, Fort Lauderdale, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-Harm Reduction

Behavioral

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.

off-site linkage

Other

standard of care linkage to a Ryan White clinic

Primary outcomes

  1. Viral suppression

    Time frame: up to 12 months

    HIV viral load <200 copies/ml time-averaged

Secondary outcomes

  1. 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.

  2. HCV cure

    Time frame: up to 12 months

    HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: T-SHARP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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