Iwuji, Collins, McGrath, Nuala, Calmy, Alexandra, Dabis, Francois, 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). e25112. ISSN 1758-2652

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Abstract

Introduction
HIV treatment guidelines now recommend antiretroviral therapy (ART) initiation regardless of CD4 count to maximise 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.

Methods
A prospective cohort study nested within a two-arm cluster-randomised trial of universal test and treat implemented March 2012 - June 2016 to measure 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, 3 and 6 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.

Results
Among 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 27.4-46.4) 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 0.95-1.05, for VAS, and 1.03, 95%CI 0.99-1.07, 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).

Conclusions
We 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.

Item Type:	Article
Keywords:	antiretroviral therapy, HIV, adherence, visual analogue scale, pill count, Africa, test and treat, virologic suppression
Schools and Departments:	Brighton and Sussex Medical School > Global Health and Infection
Research Centres and Groups:	Wellcome Trust Brighton and Sussex Centre for Global Health Research
Depositing User:	Esther Garibay
Date Deposited:	20 Jun 2018 15:16
Last Modified:	20 Jun 2018 15:41
URI:	http://srodev.sussex.ac.uk/id/eprint/76645

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