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

Specific Goals and Aims:

The major goal for this study is to determine if rapid start of antiretroviral (ART) therapy increases retention in HIV medical care. The investigators hypothesize that there will be an increase in retention in care with rapid start, by removing barriers that would normally delay enrollment in a treatment program and enforce the importance of linkage to care and ART initiation from diagnosis.

In order to test this hypothesis, the investigators have the following specific aims for their proposed study:

1. Study retention in care after rapid ART start in comparison to standard of care. 2. Analyze risk factors for decreased retention in care, with focus on high-risk populations. 3. Analyze potential demographic and geographic determinants of retention in care. 4. Generate retention in care data in a Southern US state.

The investigators hypothesize the introduction of rapid start ART, as well as the introduction of care navigators, will lead to improved clinical outcomes, including retention in care at one year, viral suppression at one year, time to viral suppression, and time to first missed appointment. In the event rapid start ART fails to have a positive impact on clinical outcomes, the results of this study will still positively contribute to the knowledge gap, since there is a scarcity of data in the Southern United States, specifically in high-risk populations, such as racial and ethnic minorities, youth, and patients co-infected with hepatitis C.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

550 Clinic

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnancy
Prior HIV diagnosis or exposure to ART
Medical necessity for therapy with ART agent other than bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), such as drug allergy, drug-drug interactions, creatinine clearance <30.

Treatment and study plan

Rapid start of antiretrovirals

Behavioral

Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days

Retrospective analysis

Behavioral

Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.

Non- RAPID start

Behavioral

Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.

Primary outcomes

Retention in Care

Time frame: 12 months

Retention in HIV care at one year after initiation of rapid ART start, defined as 1) keeping at least 3 visits within the first 12 months of care and 2) attending a clinic visit between months 9-15 of the 12-month mark and 3) experiencing no gaps in care greater than 6 months.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Acronym: RAPID

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Feb 12, 2020
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed