Trials Today

Tele-Harm Reduction

Purpose

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.

Conditions

IV Drug Usage
HIV Infections
Hepatitis C

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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.	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.
Active Comparator 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	Other: off-site linkage standard of care linkage to a Ryan White clinic

Recruiting Locations

More Details

NCT ID: NCT05208697
Status: Active, not recruiting
Sponsor: University of Miami

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.