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

University of Miami

Status and phase: Completed; Phase 4

Conditions: Harm Reduction; HIV Infections; Drug Use

Treatments: Drug: Biktarvy 50Mg-200Mg-25Mg Tablet; Other: HIV care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04650269

20200793

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Rapid ART group

Experimental group

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.

Treatment:

Other: HIV care

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