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

NCT04266938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2025-08-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-03-31
Completion
2024-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266938 on ClinicalTrials.gov