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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650269
• Other study ID #: 20200793
• Status: Completed
• Phase: Phase 4
• Start date: March 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Harm Reduction
• HIV Infections

Intervention

Drug:
• Biktarvy 50Mg-200Mg-25Mg Tablet
Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with HIV viral load suppression	HIV viral load suppression is defined as <200 copies/ml in participants' blood	6 months
Secondary	Percentage of participants with HIV viral load suppression	HIV viral load suppression is defined as <200 copies/ml in participants' blood	1 month
Secondary	Percentage of participants with HIV viral load suppression	HIV viral load suppression is defined as <200 copies/ml in participants' blood	12 months