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

Phase 4

Completed

• Conditions: Drug Use; Harm Reduction; HIV Infections
• Interventions: Drug: Biktarvy 50Mg-200Mg-25Mg Tablet; Other: HIV care

• Registration Number: NCT04650269
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-03-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-12
• Results First Submitted: 2024-12-16
• Results First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Results First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rapid ART group	HIV care	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.
Rapid ART group	Biktarvy 50Mg-200Mg-25Mg Tablet	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV Viral Load Suppression	6 months	HIV viral load suppression is defined as \<200 copies/ml in participants' blood

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV Viral Load Suppression	12 months	HIV viral load suppression is defined as \<200 copies/ml in participants' blood

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States