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Rapid ART Initiation for HIV (RAPID Trial)

N/A

Waitlist Available

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Retrospective arm: Human subjects ≥18 years old, newly diagnosed with HIV who established care at the 550 Clinic and were treated with ART between 2012-2019.

Prospective arms: Human subjects ≥18 years old, newly diagnosed with HIV who are establishing care at the 550 Clinic.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

RAPID Trial Summary

This trial will test if rapid start of antiretroviral therapy increases retention in HIV medical care.

Who is the study for?

This trial is for adults over 18 who are newly diagnosed with HIV and starting care at the 550 Clinic. It includes those treated between 2012-2019 (retrospective) and new patients (prospective). People previously diagnosed with HIV, prior ART exposure, certain medical conditions like drug allergies or low kidney function, or pregnant individuals cannot participate.Check my eligibility

What is being tested?

The study aims to see if starting antiretroviral therapy (ART) quickly after an HIV diagnosis helps keep patients in regular medical care compared to standard treatment times. It will also look into factors affecting patient retention, especially in high-risk groups within the Southern US.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ART side effects can include nausea, headaches, tiredness, and diarrhea. Serious side effects might involve changes in liver health, immune reactions or increased risk of infections.

RAPID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18, was diagnosed with HIV, and started treatment between 2012-2019.

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I am 18 or older and newly diagnosed with HIV, seeking care at the 550 Clinic.

RAPID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Retention in Care

RAPID Trial Design

3Treatment groups

Active Control

Group I: Prospective RAPIDActive Control1 Intervention

The prospective RAPID arm will include all patients who meet inclusion criteria and who start BIC/F/TAF within 7 days of HIV diagnos

Group II: Prospective Non- RAPIDActive Control1 Intervention

The prospective non-RAPID arm will include all patients identified as having new HIV diagnosis per health department records, but who failed to establish care at the 550 Clinic and begin BIC/F/TAF within one week of diagnosis

Group III: Retrospective Non- RAPIDActive Control1 Intervention

The retrospective Non-RAPID arm will include historic controls who enrolled in the treatment program from 2012, when universal ART guidelines were implemented, until prior to the implementation of RAPID start of ART.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,726 Total Patients Enrolled

Media Library

Rapid start of antiretrovirals Clinical Trial Eligibility Overview. Trial Name: NCT04266938 — N/A

HIV Research Study Groups: Prospective RAPID, Prospective Non- RAPID, Retrospective Non- RAPID

HIV Clinical Trial 2023: Rapid start of antiretrovirals Highlights & Side Effects. Trial Name: NCT04266938 — N/A

Rapid start of antiretrovirals 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266938 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies still available within this research protocol?

"Data hosted on clinicaltrials.gov indicates that recruitment for this medical study is still in progress, having initially been uploaded to the platform on June 1st 2021 and last edited 22nd of June 2022."

Answered by AI

What is the aggregate amount of patients involved in this trial?

"Yes, the latest information from clinicaltrials.gov affirms that this trial is presently recruiting participants. This study was initially posted on June 1st 2021 with an update made on June 22nd 2022 and it seeks to recruit 160 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Rapid ART Initiation on Retention in Care in the Southern US

Bailey Benidir, PharmD 2021. "Impact of Rapid ART Initiation on Retention in Care in the Southern US". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04266938.