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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | October 7, 2024 |
| Main results expected | March 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT05897099 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
- Principal investigator: Hansel Tookes, MD — University of Miami
- Study coordinator: Hansel Tookes, MD
- Email: hetookes@med.miami.edu
- Phone: 3052431615
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.