Harm ReductionPhase 4NCT04650269

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

A Phase 4 study testing Biktarvy 50Mg-200Mg-25Mg Tablet and HIV care in people with Harm Reduction and HIV Infections, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Harm Reduction, HIV Infections, Drug Use
What is being tested?: Biktarvy 50Mg-200Mg-25Mg Tablet and HIV care
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 4 Mar 2021to 31 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

1) Any other comorbidities at the discretion of the investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

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

Conditions: Harm Reduction, HIV Infections, Drug Use
Being tested: Biktarvy 50Mg-200Mg-25Mg Tablet, HIV care
Medical subject headings: Harm Reduction, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biktarvy 50Mg-200Mg-25Mg TabletDrug
Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months
HIV careOther
HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.

Study groups in NCT04650269
Study group	Role	What they receive
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. Receives: Drug: Biktarvy 50Mg-200Mg-25Mg Tablet; Other: HIV care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With HIV Viral Load Suppression
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Measured: 6 months

Secondary outcomes (2)

Percentage of Participants With HIV Viral Load Suppression
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Measured: 1 month
Percentage of Participants With HIV Viral Load Suppression
HIV viral load suppression is defined as <200 copies/ml in participants' blood
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202131 Dec 2023

First posted2 Dec 2020
Study start4 Mar 2021
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Harm ReductionStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04650269
Sponsor's protocol ID: 20200793
Status last verified: Dec 2024
First submitted: 24 Nov 2020
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Harm Reduction trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
ClinicalTrials.gov ID: NCT04650269
Acronym / sponsor ID: 20200793
Conditions: Harm Reduction, HIV Infections, Drug Use
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: 4 Mar 2021 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 2 Dec 2020 (actual)
Results: Posted 8 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rapid ART group	Experimental	Drug: Biktarvy 50Mg-200Mg-25Mg Tablet, Other: HIV carePatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (1 listed)

1) Any other comorbidities at the discretion of the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biktarvy 50Mg-200Mg-25Mg TabletDaily Biktarvy (50/200/25mg) combination ART by mouth for 6 months	Drug	Rapid ART group
HIV careHIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.	Other	Rapid ART group

Primary outcome

Percentage of Participants With HIV Viral Load Suppression
Time frame: 6 months
HIV viral load suppression is defined as <200 copies/ml in participants' blood

2 secondary outcomes

Percentage of Participants With HIV Viral Load Suppression
Time frame: 1 month
Percentage of Participants With HIV Viral Load Suppression
Time frame: 12 months

Results and safety

Results posted to the registry on 8 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rapid ART Group	27	18

Primary outcome: Percentage of Participants With HIV Viral Load Suppression

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Rapid ART Group n = 16
Value	11

Population analysed: Data was not collected for those participants that were lost to follow-up or death due to COVID pandemic

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rapid ART Group	3 of 27 (11.1%)	0 of 27 (0%)	3 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Harm Reduction

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People Who Use Opioids/People With Opioid Use Disorder (OUD)
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
Not yet recruiting
Connecting Online Military Personnel to Alcohol Harm-reducing Smartphone Support Study
Alcohol Use Disorder (AUD)
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hansel Tookes, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Biktarvy 50Mg-200Mg-25Mg Tablet and HIV care in people with Harm Reduction and HIV Infections, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HIV Viral Load Suppression (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04650269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.