search
Back to results

Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT)

Primary Purpose

HIV Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Tele-harm Reduction
Off-site Linkage to HIV Prevention
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IDEA Syringe Services Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive Tele-harm Reduction

Off-site Linkage to HIV prevention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HIV prevention via pre-exposure prophylaxis (PrEP)
Intracellular levels of tenofovir diphosphate (TFV-DP) by dried blood spot.
HIV prevention via medications for opioid use disorder
buprenorphine on urine drug screen

Secondary Outcome Measures

acceptance of HIV/hepatitis C virus (HCV) testing
receipt of HIV/HCV test results
syringe coverage
Number of syringes distributed/(number of injections per day x days between exchanges)
HCV cure
Negative HCV RNA viral load at least 12 weeks post treatment completion
acceptance of sexually transmitted infections (STI) testing
Receipt of test results for (1) gonorrhea/chlamydia screening and (2) syphilis screening
treatment of STIs
Medical records show prescription of appropriate antibiotics
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
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

Full Information

First Posted
June 1, 2023
Last Updated
September 26, 2023
Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05897099
Brief Title
Comprehensive HIV and Harm Prevention Via Telehealth
Acronym
CHARIOT
Official Title
Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 9, 2024 (Anticipated)
Primary Completion Date
March 9, 2027 (Anticipated)
Study Completion Date
October 9, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Tele-harm Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Off-site Linkage to HIV prevention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Tele-harm Reduction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Off-site Linkage to HIV Prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV prevention via pre-exposure prophylaxis (PrEP)
Description
Intracellular levels of tenofovir diphosphate (TFV-DP) by dried blood spot.
Time Frame
up to 12 months
Title
HIV prevention via medications for opioid use disorder
Description
buprenorphine on urine drug screen
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
acceptance of HIV/hepatitis C virus (HCV) testing
Description
receipt of HIV/HCV test results
Time Frame
up to 12 months
Title
syringe coverage
Description
Number of syringes distributed/(number of injections per day x days between exchanges)
Time Frame
up to 12 months
Title
HCV cure
Description
Negative HCV RNA viral load at least 12 weeks post treatment completion
Time Frame
up to 12 months
Title
acceptance of sexually transmitted infections (STI) testing
Description
Receipt of test results for (1) gonorrhea/chlamydia screening and (2) syphilis screening
Time Frame
up to 12 months
Title
treatment of STIs
Description
Medical records show prescription of appropriate antibiotics
Time Frame
up to 12 months
Title
time to harm
Description
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
Time Frame
up to 12 months
Title
number of harms
Description
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
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hansel Tookes, MD
Phone
3052431615
Email
hetookes@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansel Tookes, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tyler Bartholomew, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDEA Syringe Services Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hansel Tookes, MD
Phone
305-243-1615
Email
hetookes@med.miami.edu
Ext
Tookes
Email
hetookes@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Hansel Tookes, MD
First Name & Middle Initial & Last Name & Degree
Tyler Bartholomew, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comprehensive HIV and Harm Prevention Via Telehealth

We'll reach out to this number within 24 hrs