Evidence map›Paper›PMID 28471839›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2017

Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays.

Jessica M Fogel, Estelle Piwowar-Manning, Barbara Debevec, Tamara Walsky, Katherine Schlusser, Oliver Laeyendecker, Ethan A Wilson, Marybeth McCauley, Theresa Gamble, Gerald Tegha and 6 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Characterization of HIV humoral immunity during analytical treatment interruption.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2026
    Article
  5. Article
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  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Rapid Serological Tests Ineffectively Screen for HIV Exposure in HIV-Positive Infants.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
  15. Article
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

16 authors.

Jessica M FogelDepartments of *Pathology; and †Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD; ‡Laboratory of Immunoregulation, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, MD; §Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‖Science Facilitation Department, FHI 360, Washington, DC; ¶Science Facilitation Department, FHI 360, Durham, NC; #UNC Project Laboratory, Tidziwe Centre, Kamuzu Central Hospital, Lilongwe, Malawi; **College of Medicine-Johns Hopkins Project, Blantyre, Malawi; ††Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC; ‡‡UNC Project-Malawi, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi; §§Vaccine and Infectious Disease Division and Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA; and ‖‖Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Estelle Piwowar-Manning
Barbara Debevec
Tamara Walsky
Katherine Schlusser
Oliver Laeyendecker
Ethan A Wilson
Marybeth McCauley
Theresa Gamble
Gerald Tegha
Dean Soko
Johnstone Kumwenda
Mina C Hosseinipour
Ying Q Chen
Myron S Cohen
Susan H Eshleman

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI MYRON Scott COHEN, Sinead Delany-Moretlwe · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
International Center for Excellence in Research (ICER) in Uganda: Impact of ARVsZIAAI001040 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REYNOLDS, STEVEN · 2009 to 2025
$23.5M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Laboratory and Statistical Development of Cross-Sectional HIV Incidence AssaysR01AI095068 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ESHLEMAN, SUSAN H · 2011 to 2021
$6.6M
NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI095068NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069518
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays.

methodsSamples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm (early ART arm, N = 180) or <250 cells/mm or an AIDS-defining illness (delayed ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result).

resultsTen (4.8%) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection.

conclusionsFalse-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.

Indexed as

Early Medical InterventionAnti-HIV AgentsBlotting, WesternCD4 Lymphocyte CountCD4-Positive T-LymphocytesFemaleHIV-1HIV AntibodiesHIV SeropositivityHumansImmunoassayIncidenceMalawiMaleViral LoadAnti-HIV AgentsHIV Antibodies

Identifiers

PMID28471839
PMCPMC5499248

What OpenQuestion holds

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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.