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

NCT04650269 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20200793
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Harm Reduction; HIV Infections; Drug Use

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV Viral Load Suppression

  HIV viral load suppression is defined as \<200 copies/ml in participants' blood

  6 months

Secondary Outcomes (2)

• Percentage of Participants With HIV Viral Load Suppression

  1 month

• Percentage of Participants With HIV Viral Load Suppression

  12 months

Study Arms (1)

Rapid ART group

EXPERIMENTAL

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.

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

Interventions

Biktarvy 50Mg-200Mg-25Mg Tablet DRUG

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

Rapid ART group

HIV care 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.

Rapid ART group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) Any other comorbidities at the discretion of the investigator

Sponsors & Collaborators

• University of Miami: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Harm Reduction; HIV Infections

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Hansel Tookes
• Organization: University of Miami Miller School of Medicine

hetookes@miami.edu

3056897030

Study Officials

• Hansel Tookes, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: March 4, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)