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NCT04266938: RAPID
Impact of Rapid ART Initiation on Retention in Care in the Southern US
NA trial testing Rapid start of antiretrovirals in HIV-1-infection in 258 participants. Completed in 30 May 2024.
31 March 2024
Quick facts
| Lead sponsor | University of Louisville |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 258 |
| Start date | 1 June 2021 |
| Primary completion | 31 March 2024 |
| Estimated completion | 30 May 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rapid start of antiretrovirals
- Retrospective analysis
- Non- RAPID start
Conditions studied
- HIV-1-infection — all drugs for HIV-1-infection →
Sponsor
University of Louisville
Who can join
18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04266938
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04266938 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Louisville
- Last refreshed: 6 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04266938.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing