Tele-Harm Reduction

Study Overview
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Brief Summary
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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.

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

Conditions
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IV Drug Usage, HIV Infections, Hepatitis C

Intervention / Treatment
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* Behavioral: Tele-Harm Reduction
* Other: off-site linkage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heroin, needle exchange, syringe services program