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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Harm Reduction HIV Infections Drug Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biktarvy 50Mg-200Mg-25Mg Tablet

Intervention Type DRUG

Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months

HIV care

Intervention Type OTHER

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

Interventions

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Biktarvy 50Mg-200Mg-25Mg Tablet

Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.