Comprehensive HIV and Harm Prevention Via Telehealth

University of Miami350 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

350

Conditions

HIV Infections

Interventions

Comprehensive Tele-harm ReductionBEHAVIORAL

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 PreventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

IDEA Miami

Miami, Florida, United States

RECRUITING

IDEA Syringe Services Program

Miami, Florida, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

HIV prevention via pre-exposure prophylaxis (PrEP)

Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction

Time frame: up to 12 months

HIV prevention via medications for opioid use disorder

Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction

Time frame: up to 12 months

Secondary Outcomes

syringe coverage

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

Time frame: up to 12 months

PrEP Adherence

TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy

Time frame: up to 12 months

Engagement in HCV treatment

Direct acting antiviral prescription confirmed on electronic health record abstraction

Time frame: Up to 12 months

HCV cure

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

Time frame: up to 12 months

treatment of sexually transmitted infections

Medical records show prescription of appropriate antibiotics

Time frame: up to 12 months

time to harm

Central Contacts

Hansel Tookes, MD

CONTACT

3052431615 hetookes@med.miami.edu

Data from ClinicalTrials.gov

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