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Recruiting NCT05897099

NCT05897099 Comprehensive HIV and Harm Prevention Via Telehealth

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Clinical Trial Summary
NCT ID NCT05897099
Status Recruiting
Phase
Sponsor University of Miami
Condition HIV Infections
Study Type INTERVENTIONAL
Enrollment 350 participants
Start Date 2024-10-07
Primary Completion 2028-03-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Comprehensive Tele-harm ReductionOff-site Linkage to HIV Prevention

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 350 participants in total. It began in 2024-10-07 with a primary completion date of 2028-03-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Hansel Tookes, MD

✉ hetookes@med.miami.edu

📞 3052431615

Principal Investigator

Hansel Tookes, MD

PRINCIPAL INVESTIGATOR

University of Miami

Frequently Asked Questions

Who can join the NCT05897099 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05897099 currently recruiting?

Yes, NCT05897099 is actively recruiting participants. Contact the research team at hetookes@med.miami.edu for enrollment information.

Where is the NCT05897099 trial being conducted?

This trial is being conducted at Miami, United States, Miami, United States.

Who is sponsoring the NCT05897099 clinical trial?

NCT05897099 is sponsored by University of Miami. The principal investigator is Hansel Tookes, MD at University of Miami. The trial plans to enroll 350 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology