Tele-Harm Reduction (T-SHARP)

University of Miami

Status: Active, not recruiting

Conditions: IV Drug Usage; Hepatitis C; HIV Infections

Treatments: Other: off-site linkage; Behavioral: Tele-Harm Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05208697

DP2DA053720 (U.S. NIH Grant/Contract)

20201516

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tele-Harm Reduction (THR)

Experimental group

Description:

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.

Treatment:

Behavioral: Tele-Harm Reduction

off-site linkage to HIV care

Active Comparator group

Description:

introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic

Treatment:

Other: off-site linkage