Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Tele-Harm Reduction
- Conditions
- IV Drug Usage
- Sponsor
- University of Miami
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Viral suppression
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Investigators
Hansel Tookes
Associate Professor
University of Miami
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Tele-Harm Reduction
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
Intervention: off-site linkage
Outcomes
Primary Outcomes
Viral suppression
Time Frame: up to 12 months
HIV viral load \<200 copies/ml time-averaged
Secondary Outcomes
- HCV cure(up to 12 months)
- Initiation of medications for opioid use disorder(up to 12 months)