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Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05897099
Recruitment Status : Not yet recruiting
First Posted : June 9, 2023
Last Update Posted : April 29, 2024
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hansel Tookes, University of Miami

Tracking Information
First Submitted Date  ICMJE June 1, 2023
First Posted Date  ICMJE June 9, 2023
Last Update Posted Date April 29, 2024
Estimated Study Start Date  ICMJE August 1, 2024
Estimated Primary Completion Date March 9, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2023)
  • HIV prevention via pre-exposure prophylaxis (PrEP) [ Time Frame: up to 12 months ]
    Intracellular levels of tenofovir diphosphate (TFV-DP) by dried blood spot.
  • HIV prevention via medications for opioid use disorder [ Time Frame: up to 12 months ]
    buprenorphine on urine drug screen
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2023)
  • acceptance of HIV/hepatitis C virus (HCV) testing [ Time Frame: up to 12 months ]
    receipt of HIV/HCV test results
  • syringe coverage [ Time Frame: up to 12 months ]
    Number of syringes distributed/(number of injections per day x days between exchanges)
  • HCV cure [ Time Frame: up to 12 months ]
    Negative HCV RNA viral load at least 12 weeks post treatment completion
  • 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
  • treatment of STIs [ Time Frame: up to 12 months ]
    Medical records show prescription of appropriate antibiotics
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comprehensive HIV and Harm Prevention Via Telehealth
Official Title  ICMJE Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Comprehensive Tele-harm Reduction
  • 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.
    Intervention: Behavioral: Off-site Linkage to HIV Prevention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2023)		 350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 9, 2027
Estimated Primary Completion Date March 9, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hansel Tookes, MD 3052431615 hetookes@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05897099
Other Study ID Numbers  ICMJE 20230061
R01DA058352 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Hansel Tookes, University of Miami
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Miami
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Hansel Tookes, MD University of Miami
Principal Investigator: Tyler Bartholomew, PhD University of Miami
PRS Account University of Miami
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP