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NCT03358927
Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
NA trial testing Immediate Fast-Track Care in HIV/AIDS in 149 participants. Completed in 1 April 2021.
1 April 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 149 |
| Start date | 27 November 2018 |
| Primary completion | 1 April 2021 |
| Estimated completion | 1 April 2021 |
| Sites | 1 location across Haiti |
Drugs / interventions tested
- Immediate Fast-Track Care
- Deferred Fast-Track Care
Conditions studied
- HIV/AIDS — all drugs for HIV/AIDS →
Sponsor
Brigham and Women's Hospital
Who can join
18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the proposed R34 grant, the investigators will develop and test a strategy of immediate fast-track care. The study population will include adult patients with early HIV infection. Participants will be randomized to immediate fast-track or standard (deferred fast-track) care. All participants will receive same-day HIV testing and ART initiation prior to study enrollment. The intervention group will receive immediate fast-track care, which is conditional upon timely visits, and after 24 weeks in care, an undetectable viral load (HIV-1 RNA \<200 copies/ml). The standard group will be eligible to start fast-track care at 24 weeks, if they are on time for that visit and have an undetectable viral load. Participants in either group who are \>3 days late for any fast-track visit will lose fast-track care for that visit; those in either group with detectable viremia on their 24-week viral load test will be evaluated by a physician, with follow-up visits every 4 weeks until they have an undetectable viral load. Participants will be followed for 48 weeks. With the proposed pilot study, the investigators aim to conduct the formative work that is necessary to successfully implement a future clinical trial with the same primary outcome. The investigators hypothesize that immediate fast-track care will result in higher retention with viral suppression.
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 NCT03358927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Brigham and Women's Hospital trials
Trials by the same sponsor.
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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 NCT03358927 (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 Brigham and Women's Hospital
- Last refreshed: 9 April 2021
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/NCT03358927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing