Telehealth for HIV Prevention (CHARIOT Trial)

N/A

Recruiting

Led By Hansel Tookes, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare 2 ways of giving meds to prevent HIV, cure HCV & treat substance use disorder in people who inject drugs.

Who is the study for?

This trial is for English-speaking adults over 18 who use syringe services and plan to stay local for a year. They must test negative for HIV, not be on opioid meds or HIV prevention drugs, and can't be in jail or other trials.

What is being tested?

The study tests two methods of delivering medications to prevent HIV, possibly cure HCV, and treat substance use if desired—all through telehealth services aimed at people who inject drugs.

What are the potential side effects?

While specific side effects are not listed here, participants may experience issues related to the preventive medications for HIV/HCV and treatments for substance use disorder provided via telehealth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV prevention via medications for opioid use disorder

HIV prevention via pre-exposure prophylaxis (PrEP)

Secondary study objectives

Engagement in HCV treatment

HCV cure

PrEP Adherence

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Comprehensive Tele-harm ReductionExperimental Treatment1 Intervention

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.

Group II: Off-site Linkage to HIV preventionActive Control1 Intervention

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.

Do I qualify?Apply below to find out