Recruiting

HIV Prevention

Sponsor:

University of Miami

Code:

NCT05897099

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comprehensive Tele-harm Reduction

Off-site Linkage to HIV Prevention

Study Details

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.

Conditions

HIV Infections

Study ID

NCT05897099

Start date

Oct 7, 2024

Status verified date

Feb, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Comprehensive Tele-harm Reduction

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.

active comparator: Off-site Linkage to HIV prevention

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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Hansel Tookes, MD

3052431615hetookes@med.miami.edu

Locations

IDEA Miami

Recruiting

Miami, Florida, United States, 33136

More Information

Sponsor

University of Miami

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-02-17.