Comprehensive HIV and Harm Prevention Via Telehealth

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Comprehensive Tele-harm Reduction
* Behavioral: Off-site Linkage to HIV Prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Tele-harm Reduction<br>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<br>* 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.<br>|
| Active Comparator: Off-site Linkage to HIV prevention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV prevention via pre-exposure prophylaxis (PrEP) | Intracellular levels of tenofovir diphosphate (TFV-DP) by dried blood spot. | up to 12 months | 
| HIV prevention via medications for opioid use disorder | buprenorphine on urine drug screen | up to 12 months | 

Secondary Outcome Measures

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