Evidence map›Paper›PMID 24326604›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

Clinical versus rapid molecular HIV diagnosis in hospitalized African infants: a randomized controlled trial simulating point-of-care infant testing.

Eric D McCollum, Geoffrey A Preidis, Madalitso Maliwichi, Dan Olson, L Madeline McCrary, Peter N Kazembe, Charles van der Horst, Irving Hoffman, Mina C Hosseinipour

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Eric D McCollum*University of North Carolina Project, Lilongwe, Malawi; †Department of Pediatrics, Division of Pulmonology, Johns Hopkins School of Medicine, Baltimore, MD; ‡Department of Pediatrics, Baylor College of Medicine, Houston, TX; §Department of Pediatrics, Division of Infectious Diseases, University of Colorado, Aurora, CO; ‖Baylor College of Medicine Children's Foundation Malawi, Lilongwe, Malawi; and ¶Department of Medicine, Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC.
Geoffrey A Preidis
Madalitso Maliwichi
Dan Olson
L Madeline McCrary
Peter N Kazembe
Charles van der Horst
Irving Hoffman
Mina C Hosseinipour
Baylor College of Medicine · USJohns Hopkins University · USUniversity of Colorado Anschutz Medical Campus · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Fogarty International Clinical Research Scholars Support Center @ Vanderbilt-AAMCR24TW007988 · FIC · VANDERBILT UNIVERSITY · PI VERMUND, STEN H. · 2007 to 2011
$27.6M
Multidisciplinary Training Program in Pediatric PulmonaryT32HL072748 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI Joseph Michael Collaco · 2003 to 2026
$6.1M
FIC NIH HHS R24 TW007988NHLBI NIH HHS T32 HL072748NHLBI NIH HHS T32 HL072748-11NIAID NIH HHS 5 P30-AI50410NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

objectiveMany African infants fail to receive their diagnostic HIV molecular test results and subsequently, antiretroviral therapy (ART). To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants, we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction (Rapid PCR) and compared patient outcomes with an optimized standard care that included assessment with the World Health Organization clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks (standard care).

designRandomized controlled trial.

methodsHospitalized HIV-exposed Malawian infants aged <12 months were randomized into Rapid PCR or standard care. Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART, similar to a point-of-care test. Standard care infants meeting clinical criteria were also offered inpatient ART. The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants.

resultsThree hundred infants were enrolled. A greater proportion of HIV-infected infants receiving Rapid PCR, versus standard care, started inpatient ART (72.3% vs 47.8%, P = 0.016). Among molecular test-negative infants, 26.9% receiving standard care unnecessarily initiated inpatient ART, versus 0.0% receiving Rapid PCR (P < 0.001). Rapid PCR modestly reduced the median days to ART (3.0 vs 6.5, P = 0.001) but did not influence outpatient follow-up for HIV-infected infants (78.1% vs 82.4%, P = 0.418).

conclusionsRapid PCR, versus an optimized standard care, increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants, without meaningfully impacting time to ART initiation or follow-up rates.

Indexed as

Point-of-Care SystemsAnti-Retroviral AgentsClinical Laboratory TechniquesClinical MedicineFemaleHIV InfectionsHumansInfantInpatientsMalawiMaleMolecular Diagnostic TechniquesRandom AllocationAnti-Retroviral Agents

Identifiers

PMID24326604
PMCPMC4345126
OpenAlexW2058902286

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.