Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Telehealth approach for HIV and harm prevention

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

Run by University of Miami · NCT05897099 · Data updated 2026-11-12

This study tests if using telehealth services can help people at risk for HIV get the medications and support they need to prevent HIV, treat hepatitis C, and manage substance use.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment350 (estimated)
SponsorUniversity of Miami
Academic / other
Locations2 sites (Miami, Florida and 1 other locations)
StatusRecruiting
StartedOctober 7, 2024
Main results expectedMarch 31, 2028
Study endsMay 31, 2028
Registry record updatedFebruary 17, 2026
Trial IDNCT05897099 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 or older who speak English or Spanish, have tested negative for HIV, and have engaged in syringe exchange programs.

Probably not a fit

Patients who have a reactive HIV test or are currently receiving medications for opioid use disorder may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate two different methods of providing medications to prevent HIV, cure hepatitis C, and address substance use disorders among individuals who inject drugs. Participants will receive comprehensive tele-harm reduction services and off-site linkage to HIV prevention resources. The study focuses on individuals who are at risk for HIV but have tested negative, ensuring they have access to necessary support and treatment options. The approach leverages telehealth to enhance accessibility and engagement in care.

Why it matters

Potential benefit: If successful, this study could significantly improve access to HIV prevention and treatment services for vulnerable populations.

How similar studies have gone: Other studies have shown promise in using telehealth for HIV prevention and harm reduction, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • IDEA Miami
    Miami, Florida, United States
    Recruiting
  • IDEA Syringe Services Program
    Miami, Florida, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.