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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 : February 22, 2024
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hansel Tookes, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Comprehensive Tele-harm Reduction Behavioral: Off-site Linkage to HIV Prevention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : March 9, 2027
Estimated Study Completion Date : October 9, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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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.


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05897099


Contacts
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Contact: Hansel Tookes, MD 3052431615 hetookes@med.miami.edu

Locations
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United States, Florida
IDEA Syringe Services Program
Miami, Florida, United States, 33136
Contact: Hansel Tookes, MD    305-243-1615    hetookes@med.miami.edu   
Contact       hetookes@med.miami.edu   
Principal Investigator: Hansel Tookes, MD         
Principal Investigator: Tyler Bartholomew, PhD         
Sponsors and Collaborators
University of Miami
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Hansel Tookes, MD University of Miami
Principal Investigator: Tyler Bartholomew, PhD University of Miami
More Information
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Responsible Party: Hansel Tookes, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05897099    
Other Study ID Numbers: 20230061
R01DA058352 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases