Comprehensive HIV and Harm Prevention Via Telehealth

HIV Infections Clinical Trial

— CHARIOT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897099
• Other study ID #: 20230061
• Secondary ID: R01DA058352
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: October 9, 2027

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Hansel Tookes, MD
• Phone: 3052431615
• Email: hetookes[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: October 9, 2027
• Est. primary completion date: March 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	IDEA Syringe Services Program	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV prevention via pre-exposure prophylaxis (PrEP)	Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks by electronic health record abstraction	up to 12 months
Primary	HIV prevention via medications for opioid use disorder	Norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction	up to 12 months
Secondary	syringe coverage	Number of syringes distributed/(number of injections per day x days between exchanges)	up to 12 months
Secondary	PrEP Adherence	TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy	up to 12 months
Secondary	Engagement in HCV treatment	Direct acting antiviral prescription confirmed on electronic health record abstraction	Up to 12 months
Secondary	HCV cure	Negative HCV RNA viral load at least 12 weeks post treatment completion	up to 12 months
Secondary	treatment of sexually transmitted infections	Medical records show prescription of appropriate antibiotics	up to 12 months
Secondary	time to harm	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	up to 12 months
Secondary	number of harms	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	up to 12 months