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Recruiting NCT05897099

Comprehensive HIV and Harm Prevention Via Telehealth

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Tele-harm Reduction, Off-site Linkage to HIV Prevention.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • HIV prevention via pre-exposure prophylaxis (PrEP) [Time frame: up to 12 months]
  • HIV prevention via medications for opioid use disorder [Time frame: up to 12 months]
Secondary outcome measures (7)
  • syringe coverage [Time frame: up to 12 months]
  • PrEP Adherence [Time frame: up to 12 months]
  • Engagement in HCV treatment [Time frame: Up to 12 months]
  • HCV cure [Time frame: up to 12 months]
  • treatment of sexually transmitted infections [Time frame: up to 12 months]
  • time to harm [Time frame: up to 12 months]
  • number of harms [Time frame: up to 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • IDEA Miami — Miami
  • IDEA Syringe Services Program — Miami

Publications

  • Bartholomew TS, Plesons M, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, Chueng TA, Ciraldo K, Brooks J, Smith JD, Barocas JA, Tookes HE. Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services. Addict Sci Clin Pract. 2024 Mar 25;19 PMID 38528570

Identifiers

NCT: NCT05897099 · 20230061 · R01DA058352

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗