Comprehensive HIV and Harm Prevention Via Telehealth
CHARIOT
2 other identifiers
interventional
350
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Oct 2024
Typical duration for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
October 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
February 17, 2026
February 1, 2026
3.5 years
June 1, 2023
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
syringe coverage
up to 12 months
PrEP Adherence
up to 12 months
Engagement in HCV treatment
Up to 12 months
HCV cure
up to 12 months
treatment of sexually transmitted infections
up to 12 months
- +2 more secondary outcomes
Study Arms (2)
Comprehensive Tele-harm Reduction
EXPERIMENTALParticipants 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.
Off-site Linkage to HIV prevention
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
IDEA Miami
Miami, Florida, 33136, United States
IDEA Syringe Services Program
Miami, Florida, 33136, United States
Related Publications (1)
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.
PMID: 38528570DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hansel Tookes, MD
University of Miami
- PRINCIPAL INVESTIGATOR
Tyler Bartholomew, PhD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 9, 2023
Study Start
October 7, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share