Tele-Harm Reduction

HIV Infections Clinical Trial

— T-SHARP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208697
• Other study ID #: 20201516
• Secondary ID: DP2DA053720
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: Hansel Tookes, MD, MPH
• Phone: 3056897030
• Email: hetookes[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infections
• IV Drug Usage

Intervention

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.

Other:
• off-site linkage
standard of care linkage to a Ryan White clinic

Locations

Country	Name	City	State
United States	Care Resource The SPOT	Fort Lauderdale	Florida
United States	University of Miami	Miami	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	HIV viral load <200 copies/ml time-averaged	up to 12 months
Secondary	Initiation of medications for opioid use disorder	Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed.	up to 12 months
Secondary	HCV cure	HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion	up to 12 months