Phase 4
N=27
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Harm Reduction · HIV Infections · Drug Use
Bottom Line
View on ClinicalTrials.gov: NCT04650269 ↗Enrolled (actual)
27
Serious AEs
11.1%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Participants With HIV Viral Load Suppression — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Biktarvy 50Mg-200Mg-25Mg Tablet (Drug); HIV care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV Viral Load Suppression |
15 | — |
| SECONDARY Percentage of Participants With HIV Viral Load Suppression |
15 | — |
| SECONDARY Percentage of Participants With HIV Viral Load Suppression |
15 | — |
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.
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
- Any other comorbidities at the discretion of the investigator
Data sourced from ClinicalTrials.gov (NCT04650269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.