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Universal Test and Treat is not associated with sub-optimal antiretroviral therapy adherence in rural South Africa: The ANRS 12249 TasP Trial

Universal Test and Treat is not associated with sub-optimal antiretroviral therapy adherence in rural South Africa: The ANRS 12249 TasP Trial
Universal Test and Treat is not associated with sub-optimal antiretroviral therapy adherence in rural South Africa: The ANRS 12249 TasP Trial
IntroductionHIV treatment guidelines now recommend antiretroviral therapy (ART) initiation regardless of CD4 count to maximize benefit both for the individual and society. It is unknown whether the initiation of ART at higher CD4 counts would affect adherence levels. We investigated whether initiating ART at higher CD4 counts was associated with sub‐optimal adherence (<95%) during the first 12 months of ART.MethodsA prospective cohort study nested within a two‐arm cluster‐randomized trial of universal test and treat was implemented from March 2012 to June 2016 to measure the impact of ART on HIV incidence in rural KwaZulu‐Natal. ART was initiated regardless of CD4 count in the intervention arm and according to national guidelines in the control arm. ART adherence was measured monthly using a visual analogue scale (VAS) and pill counts (PC). HIV viral load was measured at ART initiation, three and six months, and six‐monthly thereafter. We pooled data from participants in both arms and used random‐effects logistic regression models to examine the association between CD4 count at ART initiation and sub‐optimal adherence, and assessed if adherence levels were associated with virological suppression.ResultsAmong 900 individuals who initiated ART ≥12 months before study end, median (IQR) CD4 at ART initiation was 350 cells/mm3 (234, 503); median age was 34.6 years (IQR 27.4 to 46.4) and 71.7% were female. Adherence was sub‐optimal in 14.7% of visits as measured by VAS and 20.7% by PC. In both the crude analyses and after adjusting for potential confounders, adherence was not significantly associated with CD4 count at ART initiation (adjusted OR for linear trend in sub‐optimal adherence with every 100 cells/mm3 increase in CD4 count: 1.00, 95% CI 0.95 to 1.05, for VAS, and 1.03, 95% CI 0.99 to 1.07, for PC). Virological suppression at 12 months was 97%. Optimal adherence by both measures was significantly associated with virological suppression (p < 0.001 for VAS; p = 0.006 for PC).ConclusionsWe found no evidence that higher CD4 counts at ART initiation were associated with sub‐optimal ART adherence in the first 12 months. Our findings should alleviate concerns about adherence in individuals initiating ART at higher CD4 counts, however long‐term outcomes are needed. ClinicalTrials.gov NCT01509508.
1758-2652
1-11
Iwuji, Collins
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Mcgrath, Nuala
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Calmy, Alexandra
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Dabis, François
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Pillay, Deenan
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Newell, Marie-Louise
c6ff99dd-c23b-4fef-a846-a221fe2522b3
Baisley, Kathy
5fe8c276-d9d2-4bb6-91a3-8acd38a5151f
Porter, Kholoud
84ae550b-5266-439c-894e-f1c73629210c
Iwuji, Collins
9172710f-6d53-4fc4-8948-2db34293c7ed
Mcgrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Calmy, Alexandra
f7b2f22f-1264-4266-9af2-8671307636bd
Dabis, François
90f9de2e-aaba-4392-97d6-18776521b99f
Pillay, Deenan
9f521228-ca36-4e1b-9093-64b5705b6ece
Newell, Marie-Louise
c6ff99dd-c23b-4fef-a846-a221fe2522b3
Baisley, Kathy
5fe8c276-d9d2-4bb6-91a3-8acd38a5151f
Porter, Kholoud
84ae550b-5266-439c-894e-f1c73629210c

Iwuji, Collins, Mcgrath, Nuala, Calmy, Alexandra, Dabis, François, Pillay, Deenan, Newell, Marie-Louise, Baisley, Kathy and Porter, Kholoud (2018) Universal Test and Treat is not associated with sub-optimal antiretroviral therapy adherence in rural South Africa: The ANRS 12249 TasP Trial. Journal of the International AIDS Society, 21 (6), 1-11, [e25112]. (doi:10.1002/jia2.25112).

Record type: Article

Abstract

IntroductionHIV treatment guidelines now recommend antiretroviral therapy (ART) initiation regardless of CD4 count to maximize benefit both for the individual and society. It is unknown whether the initiation of ART at higher CD4 counts would affect adherence levels. We investigated whether initiating ART at higher CD4 counts was associated with sub‐optimal adherence (<95%) during the first 12 months of ART.MethodsA prospective cohort study nested within a two‐arm cluster‐randomized trial of universal test and treat was implemented from March 2012 to June 2016 to measure the impact of ART on HIV incidence in rural KwaZulu‐Natal. ART was initiated regardless of CD4 count in the intervention arm and according to national guidelines in the control arm. ART adherence was measured monthly using a visual analogue scale (VAS) and pill counts (PC). HIV viral load was measured at ART initiation, three and six months, and six‐monthly thereafter. We pooled data from participants in both arms and used random‐effects logistic regression models to examine the association between CD4 count at ART initiation and sub‐optimal adherence, and assessed if adherence levels were associated with virological suppression.ResultsAmong 900 individuals who initiated ART ≥12 months before study end, median (IQR) CD4 at ART initiation was 350 cells/mm3 (234, 503); median age was 34.6 years (IQR 27.4 to 46.4) and 71.7% were female. Adherence was sub‐optimal in 14.7% of visits as measured by VAS and 20.7% by PC. In both the crude analyses and after adjusting for potential confounders, adherence was not significantly associated with CD4 count at ART initiation (adjusted OR for linear trend in sub‐optimal adherence with every 100 cells/mm3 increase in CD4 count: 1.00, 95% CI 0.95 to 1.05, for VAS, and 1.03, 95% CI 0.99 to 1.07, for PC). Virological suppression at 12 months was 97%. Optimal adherence by both measures was significantly associated with virological suppression (p < 0.001 for VAS; p = 0.006 for PC).ConclusionsWe found no evidence that higher CD4 counts at ART initiation were associated with sub‐optimal ART adherence in the first 12 months. Our findings should alleviate concerns about adherence in individuals initiating ART at higher CD4 counts, however long‐term outcomes are needed. ClinicalTrials.gov NCT01509508.

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JIAS_Adherence Collins TasP paper - Accepted Manuscript
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More information

Accepted/In Press date: 26 April 2018
e-pub ahead of print date: 11 June 2018
Published date: June 2018

Identifiers

Local EPrints ID: 420332
URI: http://eprints.soton.ac.uk/id/eprint/420332
ISSN: 1758-2652
PURE UUID: 931c0d2b-f885-4c08-89cc-9269c05bbd82
ORCID for Nuala Mcgrath: ORCID iD orcid.org/0000-0002-1039-0159
ORCID for Marie-Louise Newell: ORCID iD orcid.org/0000-0002-1074-7699

Catalogue record

Date deposited: 04 May 2018 16:30
Last modified: 17 Dec 2019 05:27

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