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Clinical Trials/NCT04650269
NCT04650269
Completed
Phase 4

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

University of Miami1 site in 1 country27 target enrollmentMarch 4, 2021

Overview

Phase
Phase 4
Intervention
Biktarvy 50Mg-200Mg-25Mg Tablet
Conditions
Harm Reduction
Sponsor
University of Miami
Enrollment
27
Locations
1
Primary Endpoint
Percentage of Participants With HIV Viral Load Suppression
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2021
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hansel Tookes

Assistant Professor

University of Miami

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Biktarvy 50Mg-200Mg-25Mg Tablet

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.

Intervention: HIV care

Outcomes

Primary Outcomes

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

  • Percentage of Participants With HIV Viral Load Suppression(12 months)

Study Sites (1)

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