Tele-Harm Reduction

N/AActive Not RecruitingNCT05208697

University of Miami100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

IV Drug Usage HIV Infections Hepatitis C

Interventions

Tele-Harm ReductionBEHAVIORAL

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 linkageOTHER

standard of care linkage to a Ryan White clinic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Care Resource The SPOT

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

Viral suppression

HIV viral load \<200 copies/ml time-averaged

Time frame: up to 12 months

Secondary Outcomes

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.

Time frame: up to 12 months

HCV cure

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

Time frame: up to 12 months

Data from ClinicalTrials.gov

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