Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT)

Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Comprehensive Tele-harm Reduction; Behavioral: Off-site Linkage to HIV Prevention

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hansel Tookes, MD; Phone Number: 3052431615; Email: hetookes@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • IDEA Miami
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • IDEA Syringe Services Program
      • Principal Investigator: Hansel Tookes, MD
      • Contact: Email: hetookes@med.miami.edu
      • Contact: Hansel Tookes, MD; Phone Number: 305-243-1615; Email: hetookes@med.miami.edu
      • Principal Investigator: Tyler Bartholomew, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive Tele-harm Reduction; 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.	Behavioral: Comprehensive Tele-harm Reduction; Comprehensive Tele-Harm Reduction is on-demand services including low-barrier access to PrEP, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, peer harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an syringe services program.
Active Comparator: Off-site Linkage to HIV prevention; 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.	Behavioral: Off-site Linkage to HIV Prevention; The community engagement team is comprised of peers and social workers and provides the wraparound support needed.The team will assist participants in scheduling appointments at community health clinics. The community engagement team provides active clinic referral- that is, a member of the team will accompany patients to the first clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV prevention via pre-exposure prophylaxis (PrEP)	Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction	up to 12 months
HIV prevention via medications for opioid use disorder	Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
syringe coverage	Number of syringes distributed/(number of injections per day x days between exchanges)	up to 12 months
HCV cure	Negative HCV RNA viral load at least 12 weeks post treatment completion	up to 12 months
time to harm	Time to: (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose	up to 12 months
number of harms	Count of (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose	up to 12 months
PrEP Adherence	TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy	up to 12 months
Engagement in HCV treatment	Direct acting antiviral prescription confirmed on electronic health record abstraction	Up to 12 months
treatment of sexually transmitted infections	Medical records show prescription of appropriate antibiotics	up to 12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Hansel Tookes, MD, University of Miami; Principal Investigator: Tyler Bartholomew, PhD, University of Miami

Publications and helpful links

General Publications

• Bartholomew TS, Plesons M, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, Chueng TA, Ciraldo K, Brooks J, Smith JD, Barocas JA, Tookes HE. Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services. Addict Sci Clin Pract. 2024 Mar 25;19(1):21. doi: 10.1186/s13722-024-00447-9.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 20230061; R01DA058352 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No