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Understanding low sensitivity of community-based HIV rapid testing: experiences from the HPTN 071 (PopART) trial in Zambia and South Africa

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Title: Understanding low sensitivity of community-based HIV rapid testing: experiences from the HPTN 071 (PopART) trial in Zambia and South Africa
Authors: Bock, P
Phiri, C
Piwowar-Manning, E
Kosloff, B
Mandla, N
Young, A
James, A
Schaap, A
Scheepers, M
Donnell, D
Griffith, S
El-Sadr, W
Shanaube, K
Beyers, N
Hayes, R
Fidler, S
Ayles, H
Item Type: Journal Article
Abstract: Introduction: Population-wide HIV testing services (HTS) must be delivered in order to achieve universal antiretroviral treatment (ART) coverage. To accurately deliver HTS at such scale, non-facility-based HIV point-of-care testing (HIV-POCT) is necessary but requires rigorous quality assurance (QA). This study assessed the performance of community-wide HTS in Zambia and South Africa (SA) as part of the HPTN 071 (PopART) study and explores the impact of quality improvement interventions on HTS performance. Methods: Between 2014 and 2016, HIV-POCT was undertaken within households both as part of the randomly selected HPTN 071 research cohort (Population Cohort [PC]) and as part of the intervention provided by community HIV-care providers. HIV-POCT followed national algorithms in both countries. Consenting PC participants provided a venous blood sample in addition to being offered HIV-POCT. We compared results obtained in the PC using a laboratory-based gold standard (GS) testing algorithm and HIV-POCT. Comprehensive QA mechanisms were put in place to support the community-wide testing. Participants who were identified as having a false negative or false positive HIV rapid test were revisited and offered retesting. Results: We initially observed poor sensitivity (45–54%, 95% confidence interval [CI] 31–69) of HIV-POCT in the PC in SA compared to sensitivity in Zambia for the same time period of 95.8% (95% CI 93–98). In both countries, specificity of HIV-POCT was >98%. With enhanced QA interventions and adoption of the same HIV-POCT algorithm, sensitivity in SA improved to a similar level as in Zambia. Conclusions: This is one of the first reports of HIV-POCT performance during wide-scale delivery of HTS compared to a GS laboratory algorithm. HIV-POCT in a real-world setting had a lower sensitivity than anticipated. Appropriate choice of HIV-POCT algorithms, intensive training and supervision, and robust QA mechanisms are necessary to optimize HIV-POCT test performance when testing is delivered at a community level. HIV-POCT in clients who did not disclose that they were on ART may have contributed to false negative HIV-POCT results and should be the topic of future research.
Issue Date: 29-Aug-2017
Date of Acceptance: 25-Jun-2017
URI: http://hdl.handle.net/10044/1/52057
DOI: https://dx.doi.org/10.7448/IAS.20.7.21780
ISSN: 1758-2652
Publisher: International AIDS Society
Journal / Book Title: JOURNAL OF THE INTERNATIONAL AIDS SOCIETY
Volume: 20
Copyright Statement: © 2017 Bock P et al; licensee International AIDS Society. This is an open access article under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/3.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Sponsor/Funder: National Institutes of Health
Funder's Grant Number: PO15001410 (UMIAI068619)
Keywords: Science & Technology
Life Sciences & Biomedicine
Immunology
Infectious Diseases
HIV rapid test
community
household
sensitivity
quality control
HPTN 071 (PopART)
CLUSTER-RANDOMIZED-TRIAL
NIMH PROJECT ACCEPT
INFECTED CHILDREN
INTERVENTION
MALAWI
HPTN 071 (PopART) Study Team
1199 Other Medical And Health Sciences
Publication Status: Published
Article Number: ARTN 21780
Appears in Collections:Department of Medicine
Faculty of Medicine



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