Back to resultsImplementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Primary Purpose
Harm Reduction, HIV Infections, Drug Use
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Biktarvy 50Mg-200Mg-25Mg Tablet
HIV care
Sponsored by
About this trial
This is an interventional treatment trial for Harm Reduction
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:
1) Any other comorbidities at the discretion of the investigator
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rapid ART group
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of participants with HIV viral load suppression
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Secondary Outcome Measures
Percentage of participants with HIV viral load suppression
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Percentage of participants with HIV viral load suppression
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04650269
Brief Title
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Official Title
Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Harm Reduction, HIV Infections, Drug Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid ART group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Biktarvy 50Mg-200Mg-25Mg Tablet
Intervention Description
Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months
Intervention Type
Other
Intervention Name(s)
HIV care
Intervention Description
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 Outcome Measure Information:
Title
Percentage of participants with HIV viral load suppression
Description
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of participants with HIV viral load suppression
Description
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Time Frame
1 month
Title
Percentage of participants with HIV viral load suppression
Description
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
1) Any other comorbidities at the discretion of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansel Tookes, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
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