ClinicalTrials.gov
History of Changes for Study: NCT05897099
Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT)
Latest version (submitted April 26, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 1, 2023 None (earliest Version on record)
2 June 9, 2023 Study Status and Study Identification
3 September 26, 2023 Study Status
4 February 20, 2024 Study Status
5 April 26, 2024 Study Status
Comparison Format:
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Study NCT05897099
Submitted Date:  June 1, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: 20230061
Brief Title: Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT)
Official Title: Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2023
Overall Status: Not yet recruiting
Study Start: October 9, 2023
Primary Completion: October 9, 2027 [Anticipated]
Study Completion: October 9, 2027 [Anticipated]
First Submitted: June 1, 2023
First Submitted that
Met QC Criteria:		 June 1, 2023
First Posted: June 9, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 1, 2023
Last Update Posted: June 9, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Miami
Responsible Party: Principal Investigator
Investigator: Hansel Tookes
Official Title: Associate Professor
Affiliation: University of Miami
Collaborators: National Institute on Drug Abuse (NIDA)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: HIV Infections
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 350 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. HIV prevention via pre-exposure prophylaxis (PrEP)
[ Time Frame: up to 12 months ]

Intracellular levels of tenofovir diphosphate (TFV-DP) by dried blood spot.
2. HIV prevention via medications for opioid use disorder
[ Time Frame: up to 12 months ]

buprenorphine on urine drug screen
Secondary Outcome Measures:
1. acceptance of HIV/hepatitis C virus (HCV) testing
[ Time Frame: up to 12 months ]

receipt of HIV/HCV test results
2. syringe coverage
[ Time Frame: up to 12 months ]

Number of syringes distributed/(number of injections per day x days between exchanges)
3. HCV cure
[ Time Frame: up to 12 months ]

Negative HCV RNA viral load at least 12 weeks post treatment completion
4. acceptance of sexually transmitted infections (STI) testing
[ Time Frame: up to 12 months ]

Receipt of test results for (1) gonorrhea/chlamydia screening and (2) syphilis screening
5. treatment of STIs
[ Time Frame: up to 12 months ]

Medical records show prescription of appropriate antibiotics
6. time to harm
[ Time Frame: up to 12 months ]

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
7. number of harms
[ Time Frame: up to 12 months ]

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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • age 18 or older
  • able to speak English
  • 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)
  • currently on PrEP
  • Principal or site investigator discretion
  • currently in prison or jail
  • current enrollment in Clinical Trials Network 121
Open or close this module Contacts/Locations
Central Contact Person: Hansel Tookes, MD
Telephone: 3052431615
Email: hetookes@med.miami.edu
Study Officials: Hansel Tookes, MD
Principal Investigator
University of Miami
Tyler Bartholomew, PhD
Principal Investigator
University of Miami
Locations: United States, Florida
IDEA Syringe Services Program
Miami, Florida, United States, 33136
Contact:Contact: Hansel Tookes, MD 305-243-1615 hetookes@med.miami.edu
Contact:Contact: hetookes@med.miami.edu
Contact:Principal Investigator: Hansel Tookes, MD
Contact:Principal Investigator: Tyler Bartholomew, PhD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services