NCT04266938

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BEHAVIORAL	Rapid start of antiretrovirals	Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days
BEHAVIORAL	Retrospective analysis	Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.
BEHAVIORAL	Non- RAPID start	Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-03-31
• Completion: 2024-05-30
• First posted: 2020-02-12
• Last updated: 2025-08-06

Locations

1 site across 1 country: United States