Comprehensive HIV and Harm Prevention Via Telehealth

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05897099
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive Tele-harm Reduction — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 7, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

HIV prevention via pre-exposure prophylaxis (PrEP) [ Time Frame: up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
IDEA MiamiMiamiFlorida33136-
IDEA Syringe Services ProgramMiamiFlorida33136
Hansel Tookes, MD
[email protected]
305-243-1615
[email protected]
Hansel Tookes, MD (PRINCIPAL_INVESTIGATOR)
Tyler Bartholomew, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
HIV
By specialty
Infectious disease
By research site
IDEA Miami· Miami, FLIDEA Syringe Services Program· Miami, FL

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