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

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT04650269
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
39.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Biktarvy 50Mg-200Mg-25Mg Tablet
  • Other: HIV care
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Actual Study Start Date :
Mar 4, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants with HIV viral load suppression [6 months]

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

Secondary Outcome Measures

  1. Percentage of participants with HIV viral load suppression [1 month]

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

  2. Percentage of participants with HIV viral load suppression [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami

Investigators

  • Principal Investigator: Hansel Tookes, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hansel Tookes, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT04650269
Other Study ID Numbers:
  • 20200793
First Posted:
Dec 2, 2020
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
HIV Infections
Emtricitabine

Study Results

No Results Posted as of May 10, 2022