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Recruiting

NCT Number: NCT05897099

Comprehensive HIV and Harm Prevention Via Telehealth

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.

Recruiting

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDEA Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Tele-harm Reduction

Behavioral

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.

Off-site Linkage to HIV Prevention

Behavioral

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.

Primary outcomes

  1. HIV prevention via pre-exposure prophylaxis (PrEP)

    Time frame: up to 12 months

    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

  2. HIV prevention via medications for opioid use disorder

    Time frame: up to 12 months

    Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction

Secondary outcomes

  1. syringe coverage

    Time frame: up to 12 months

    Number of syringes distributed/(number of injections per day x days between exchanges)

  2. PrEP Adherence

    Time frame: up to 12 months

    TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy

  3. Engagement in HCV treatment

    Time frame: Up to 12 months

    Direct acting antiviral prescription confirmed on electronic health record abstraction

  4. HCV cure

    Time frame: up to 12 months

    Negative HCV RNA viral load at least 12 weeks post treatment completion

  5. treatment of sexually transmitted infections

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hansel Tookes, MD

CONTACT

[email protected]

3052431615

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: CHARIOT

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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