It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.

Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a...

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Main Authors: Ross M Boyce, Ronnie Ndizeye, Herbert Ngelese, Emmanuel Baguma, Bwambale Shem, Rebecca J Rubinstein, Emmanuel Rockwell, Sarah C Lotspeich, Bonnie E Shook-Sa, Moses Ntaro, Dan Nyehangane, David A Wohl, Mark J Siedner, Edgar M Mulogo
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2023-01-01
Series:PLOS Global Public Health
Online Access:https://doi.org/10.1371/journal.pgph.0001678
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author Ross M Boyce
Ronnie Ndizeye
Herbert Ngelese
Emmanuel Baguma
Bwambale Shem
Rebecca J Rubinstein
Emmanuel Rockwell
Sarah C Lotspeich
Bonnie E Shook-Sa
Moses Ntaro
Dan Nyehangane
David A Wohl
Mark J Siedner
Edgar M Mulogo
author_facet Ross M Boyce
Ronnie Ndizeye
Herbert Ngelese
Emmanuel Baguma
Bwambale Shem
Rebecca J Rubinstein
Emmanuel Rockwell
Sarah C Lotspeich
Bonnie E Shook-Sa
Moses Ntaro
Dan Nyehangane
David A Wohl
Mark J Siedner
Edgar M Mulogo
author_sort Ross M Boyce
collection DOAJ
description Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2-7). Time from sample collection to result was 51 days (IQR = 45-62) for samples sent to the central laboratory and 0 days (IQR = 0-0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04517825.
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spelling doaj.art-1a622a785c6c4fd7aa59f6fceb8475a12023-09-03T09:00:00ZengPublic Library of Science (PLoS)PLOS Global Public Health2767-33752023-01-0133e000167810.1371/journal.pgph.0001678It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.Ross M BoyceRonnie NdizeyeHerbert NgeleseEmmanuel BagumaBwambale ShemRebecca J RubinsteinEmmanuel RockwellSarah C LotspeichBonnie E Shook-SaMoses NtaroDan NyehanganeDavid A WohlMark J SiednerEdgar M MulogoBarriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2-7). Time from sample collection to result was 51 days (IQR = 45-62) for samples sent to the central laboratory and 0 days (IQR = 0-0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04517825.https://doi.org/10.1371/journal.pgph.0001678
spellingShingle Ross M Boyce
Ronnie Ndizeye
Herbert Ngelese
Emmanuel Baguma
Bwambale Shem
Rebecca J Rubinstein
Emmanuel Rockwell
Sarah C Lotspeich
Bonnie E Shook-Sa
Moses Ntaro
Dan Nyehangane
David A Wohl
Mark J Siedner
Edgar M Mulogo
It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
PLOS Global Public Health
title It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
title_full It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
title_fullStr It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
title_full_unstemmed It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
title_short It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.
title_sort it takes more than a machine a pilot feasibility study of point of care hiv 1 viral load testing at a lower level health center in rural western uganda
url https://doi.org/10.1371/journal.pgph.0001678
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