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NCT04266938 · ClinicalTrials.gov registry record · NA
Impact of Rapid ART Initiation on Retention in Care in the Southern US
A NA study, sponsored by University of Louisville.
- Completed
- Registry status
- NA
- Development phase
- 258
- Enrollment target
NCT04266938: Completed NA study, sponsored by University of Louisville.
NCT04266938 is a NA study that has completed, run by University of Louisville. The registered enrollment target is 258 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04266938, a NA study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- NA
- Development phase
- 258 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Rapid start of antiretrovirals
- BEHAVIORAL Retrospective analysis
- BEHAVIORAL Non- RAPID start
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2024-05-30 |
| Phase | NA |
What the finished NCT04266938 record still lists
NCT04266938 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Rapid start of antiretrovirals is the first listed.
NCT04266938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04266938 about?
NCT04266938 is a clinical study titled "Impact of Rapid ART Initiation on Retention in Care in the Southern US". 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 rete...
What is the current status of trial NCT04266938?
This trial is currently completed. It is a NA study. The enrollment target is 258 participants. The study started on 2021-06-01. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT04266938?
The interventions under investigation include: Rapid start of antiretrovirals (BEHAVIORAL), Retrospective analysis (BEHAVIORAL), Non- RAPID start (BEHAVIORAL).
Who is sponsoring clinical trial NCT04266938?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04266938's enrollment target sits among peer trials
258 402nd of 2000 higher than 1,598 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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