Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Drug Use; Harm Reduction
• Intervention / Treatment: Drug: Biktarvy 50Mg-200Mg-25Mg Tablet; Other: HIV care

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult (age>18 years);
2. positive rapid HIV test;
3. ability to provide informed consent;
4. HIV RNA > 200 copies/ml;
5. creatinine clearance > 30 mg/dl as measured by serum creatinine;
6. no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies.

Exclusion Criteria:

1) Any other comorbidities at the discretion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid ART group; Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.	Drug: Biktarvy 50Mg-200Mg-25Mg Tablet; Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months; Other: HIV care; HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With HIV Viral Load Suppression	HIV viral load suppression is defined as <200 copies/ml in participants' blood	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With HIV Viral Load Suppression	HIV viral load suppression is defined as <200 copies/ml in participants' blood	1 month
Percentage of Participants With HIV Viral Load Suppression	HIV viral load suppression is defined as <200 copies/ml in participants' blood	12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Hansel Tookes, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine
• Other Study ID Numbers: 20200793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No