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Determination of HIV status and identification of incident HIV infections in a large, community-randomized trial: HPTN 071 (PopART)

Title: Determination of HIV status and identification of incident HIV infections in a large, community-randomized trial: HPTN 071 (PopART)
Authors: Eshleman, SH
Piwowar-Manning, E
Wilson, EA
Lennon, D
Fogel, JM
Agyei, Y
Sullivan, PA
Weng, L
Moore, A
Laeyendecker, O
Kosloff, B
Bwalya, J
Maarman, G
Van Deventer, A
Floyd, S
Bock, P
Ayles, H
Fidler, S
Hayes, R
Donnell, D
HPTN 071 (PopART) Study Team
Item Type: Journal Article
Abstract: INTRODUCTION: The HPTN 071 (PopART) trial evaluated the impact of an HIV combination prevention package that included "universal testing and treatment" on HIV incidence in 21 communities in Zambia and South Africa during 2013-2018. The primary study endpoint was based on the results of laboratory-based HIV testing for> 48,000 participants who were followed for up to three years. This report evaluated the performance of HIV assays and algorithms used to determine HIV status and identify incident HIV infections in HPTN 071, and assessed the impact of errors on HIV incidence estimates. METHODS: HIV status was determined using a streamlined, algorithmic approach. A single HIV screening test was performed at centralized laboratories in Zambia and South Africa (all participants, all visits). Additional testing was performed at the HPTN Laboratory Center using antigen/antibody screening tests, a discriminatory test and an HIV RNA test. This testing was performed to investigate cases with discordant test results and confirm incident HIV infections. RESULTS: HIV testing identified 978 seroconverter cases. This included 28 cases where the participant had acute HIV infection at the first HIV-positive visit. Investigations of cases with discordant test results identified cases where there was a participant or sample error (mixups). Seroreverter cases (errors where status changed from HIV infected to HIV uninfected, 0.4% of all cases) were excluded from the primary endpoint analysis. Statistical analysis demonstrated that exclusion of those cases improved the accuracy of HIV incidence estimates. CONCLUSIONS: This report demonstrates that the streamlined, algorithmic approach effectively identified HIV infections in this large cluster-randomized trial. Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.
Issue Date: 1-Feb-2020
Date of Acceptance: 14-Jan-2020
URI: http://hdl.handle.net/10044/1/77279
DOI: 10.1002/jia2.25452
ISSN: 1758-2652
Publisher: International AIDS Society
Journal / Book Title: Journal of the International AIDS Society
Volume: 23
Issue: 2
Copyright Statement: ©2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.This is an open access article under the terms of the Creative Commons Attribution License, 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: HIV incidence
HIV testing
South Africa
Zambia
community-randomized
seroconverters
HPTN 071 (PopART) Study Team
HIV incidence
HIV testing
South Africa
Zambia
community-randomized
seroconverters
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status: Published
Conference Place: Switzerland
Article Number: ARTN e25452
Online Publication Date: 2020-02-18
Appears in Collections:Department of Infectious Diseases