CHARIOT: Comprehensive HIV and Harm Prevention Via Telehealth

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05897099
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 350
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Comprehensive Tele-harm Reduction; Behavioral: Off-site Linkage to HIV Prevention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
• Anticipated Study Start Date: Oct 9, 2023
• Anticipated Primary Completion Date: Oct 9, 2027
• Anticipated Study Completion Date: Oct 9, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comprehensive Tele-harm Reduction 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.	Behavioral: Comprehensive Tele-harm Reduction; 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.
Active Comparator: Off-site Linkage to HIV prevention 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.	Behavioral: Off-site Linkage to HIV Prevention; 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.

Outcome Measures

Primary Outcome Measures

1. HIV prevention via pre-exposure prophylaxis (PrEP) [up to 12 months]

   Intracellular levels of tenofovir diphosphate (TFV-DP) by dried blood spot.

2. HIV prevention via medications for opioid use disorder [up to 12 months]

   buprenorphine on urine drug screen

Secondary Outcome Measures

1. acceptance of HIV/hepatitis C virus (HCV) testing [up to 12 months]

   receipt of HIV/HCV test results

2. syringe coverage [up to 12 months]

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

3. HCV cure [up to 12 months]

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

4. acceptance of sexually transmitted infections (STI) testing [up to 12 months]

   Receipt of test results for (1) gonorrhea/chlamydia screening and (2) syphilis screening

5. treatment of STIs [up to 12 months]

   Medical records show prescription of appropriate antibiotics

6. time to harm [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18 or older

• able to speak English

• 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)

• currently on PrEP

• Principal or site investigator discretion

• currently in prison or jail

• current enrollment in Clinical Trials Network 121

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IDEA Syringe Services Program	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Hansel Tookes, MD, University of Miami
• Principal Investigator: Tyler Bartholomew, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hansel Tookes, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT05897099
• Other Study ID Numbers: 20230061; R01DA058352
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Jun 12, 2023