Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT)

University of Miami

Status: Enrolling

Conditions: HIV Infections

Treatments: Behavioral: Off-site Linkage to HIV Prevention; Behavioral: Comprehensive Tele-harm Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05897099

R01DA058352 (U.S. NIH Grant/Contract)

20230061

Details and patient eligibility

About

The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 or older
• able to speak English or Spanish
• willing and able to sign informed consent, provide locator information and medical records release
• non-reactive result on rapid HIV test
• use of SSP to exchange syringes 2 times in the past 3 months
• planning to stay in the area for 12 months

Exclusion criteria

• reactive HIV test
• currently on medications for opioid use disorder (MOUD) by urine drug screen
• currently on PrEP by self-report
• Principal or site investigator discretion
• currently in prison or jail
• current enrollment in Clinical Trials Network 121
• receipt of tele-harm reduction in previous 3 months
• signs or symptoms of acute HIV infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Comprehensive Tele-harm Reduction

Experimental group

Description:

Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months.

Treatment:

Behavioral: Comprehensive Tele-harm Reduction

Off-site Linkage to HIV prevention

Active Comparator group

Description:

Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months.

Treatment:

Behavioral: Off-site Linkage to HIV Prevention