Telehealth approach for HIV and harm prevention
Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05897099 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using telehealth for HIV prevention and harm reduction, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Miami, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.