Evidence map›Paper›PMID 33285419›Full record

ArticleEpidemics2020

Assessing the use of surveillance data to estimate the impact of prevention interventions on HIV incidence in cluster-randomized controlled trials.

Kate M Mitchell, Dobromir Dimitrov, James P Hughes, Mia Moore, Eric Vittinghoff, Albert Liu, Myron S Cohen, Chris Beyrer, Deborah Donnell, Marie-Claude Boily

Abstract read
In one paragraph

Article in Epidemics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. How Can Progress Toward Ending the Human Immunodeficiency Virus Epidemic in the United States Be Monitored?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    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

10 authors.

Kate M MitchellMedical Research Council Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom; HIV Prevention Trials Network Modelling Centre, Imperial College London, London, United Kingdom. Electronic address: kate.mitchell@imperial.ac.uk.
Dobromir DimitrovVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA.
James P HughesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA; Department of Biostatistics, University of Washington, Seattle, USA.
Mia MooreVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA.
Eric VittinghoffDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, USA.
Albert LiuDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, USA; Bridge HIV, Population Health Division, San Francisco Department of Public Health, San Francisco, USA.
Myron S CohenInstitute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Chris BeyrerDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.
Deborah DonnellVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, USA.
Marie-Claude BoilyMedical Research Council Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom; HIV Prevention Trials Network Modelling Centre, Imperial College London, London, United Kingdom.

Funding

SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
HIV IN SEMEN-EFFECTS OF STDS AND ANTIVIRAL THERAPYR37DK049381 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI COHEN, MYRON SCOTT · 2005 to 2014
$3.4M
Medical Research Council MR/R015600/1NIAID NIH HHS U01 AI068619NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI069496NIDDK NIH HHS R37 DK049381
6 · The paper itself

Abstract

backgroundIn cluster-randomized controlled trials (C-RCTs) of HIV prevention strategies, HIV incidence is expensive to measure directly. Surveillance data on HIV diagnoses or viral suppression could provide cheaper incidence estimates. We used mathematical modelling to evaluate whether these measures can replace HIV incidence measurement in C-RCTs.

methodsWe used a US HIV transmission model to simulate C-RCTs of expanded antiretroviral therapy(ART), pre-exposure prophylaxis(PrEP) and HIV testing, together or alone. We tested whether modelled reductions in total new HIV diagnoses, diagnoses with acute infection, diagnoses with early infection(CD4 > 500 cells/μl), diagnoses adjusted for testing volume, or the proportion virally non-suppressed, reflected HIV incidence reductions.

resultsOver a two-year trial expanding PrEP alone, modelled reductions in total diagnoses underestimated incidence reductions by a median six percentage points(pp), with acceptable variability(95 % credible interval -14,-2pp). For trials expanding HIV testing alone or alongside ART + PrEP, greater, highly variable bias was seen[-20pp(-128,-1) and -30pp(-134,-16), respectively]. Acceptable levels of bias were only seen over longer trial durations when levels of awareness of HIV-positive status were already high. Expanding ART alone, only acute and early diagnoses reductions reflected incidence reduction well, with some bias[-3pp(-6,-1) and -8pp(-16,-3), respectively]. Early and adjusted diagnoses also reliably reflected incidence when scaling up PrEP alone[bias -5pp(-11,1) and 10pp(3,18), respectively]. For trials expanding testing (alone or with ART + PrEP), bias for all measures explored was too variable for them to replace direct incidence measures, unless using diagnoses when HIV status awareness was already high.

conclusionsSurveillance measures based on HIV diagnoses may sometimes be adequate surrogates for HIV incidence reduction in C-RCTs expanding ART or PrEP only, if adjusted for bias. However, all surveillance measures explored failed to approximate HIV incidence reductions for C-RCTs expanding HIV testing, unless levels of awareness of HIV-positive status were already high.

Indexed as

Randomized Controlled Trials as TopicAdultAnti-HIV AgentsHIV InfectionsHumansIncidenceMaleModels, TheoreticalPre-Exposure ProphylaxisAnti-HIV AgentsHIVIncidenceMarkerMathematical modellingSurveillance dataTrials

Identifiers

PMID33285419
PMCPMC7938213

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Registered trials

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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.