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OpenTrials
Completed

NCT Number: NCT04650269

Implementation of Onsite, Rapid 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.

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Key information

Conditions

Harm Reduction Behavior Blood-Borne Infections Communicable Diseases Drug Use Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any other comorbidities at the discretion of the investigator

Treatment and study plan

BIKTARVY 50Mg-200Mg-25Mg Tablet

Drug

Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months

HIV care

Other

HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.

Primary outcomes

  1. Percentage of Participants With HIV Viral Load Suppression

    Time frame: 6 months

    HIV viral load suppression is defined as <200 copies/ml in participants' blood

Secondary outcomes

  1. Percentage of Participants With HIV Viral Load Suppression

    Time frame: 1 month

    HIV viral load suppression is defined as <200 copies/ml in participants' blood

  2. Percentage of Participants With HIV Viral Load Suppression

    Time frame: 12 months

    HIV viral load suppression is defined as <200 copies/ml in participants' blood

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2020
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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