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HIV and Harm Prevention via Telehealth

This study is looking at two different ways to help people who inject drugs prevent HIV, treat hepatitis C (if needed), and manage substance use disorder. We are comparing "Comprehensive Tele-harm Reduction" (on-demand services like PrEP access, substance use disorder and hepatitis C treatment, mobile blood draws, and counseling) with "Off-site Linkage to HIV Prevention" (where a team helps you schedule appointments at community clinics). The goal is to see how well these methods prevent HIV over 12 months. You might be able to join if you are 18 or older, speak English or Spanish, have recently exchanged syringes, and plan to stay in the area for a year. You cannot have a reactive HIV test.

Study design
This interventional study plans to enroll 350 participants to compare two different behavioral interventions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months to measure HIV prevention outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05897099

Comprehensive HIV and Harm Prevention Via Telehealth

Recruiting
NAAges 18+InterventionalPrevention
University of Miami
~350 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Comprehensive Tele-harm ReductionOff-site Linkage to HIV Prevention

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HIV prevention via pre-exposure prophylaxis (PrEP)
Measured over up to 12 months
+1 more outcome measured

Conditions

HIV Infections

Explore related trials

HIV InfectionHIV Infection

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Hansel Tookes, MD · PRINCIPAL_INVESTIGATOR · University of Miami
  • Tyler Bartholomew, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Hansel Tookes, MD
[email protected]
3052431615
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • HIV prevention via pre-exposure prophylaxis (PrEP)up to 12 months

    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

  • HIV prevention via medications for opioid use disorderup to 12 months

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