Abstract
BackgroundPoverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients’ adherence to treatment, and their treatment outcomes. Although the trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. A qualitative process evaluation, conducted in the final few months of the trial, explained some of the factors that contributed to this low fidelity.MethodsIn-depth interviews were conducted with patients who received vouchers, nurses in intervention clinics, personnel in shops who administered the vouchers, and managers of the TB Control Programme. These interviews were analyzed thematically.ResultsThe low fidelity to the trial intervention can be explained by two main factors. The first was nurses’ tendency to ‘ration’ the vouchers, only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable. The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates, necessitating further visits to the clinics which they were not always able to make.ConclusionsThis process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial. It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ‘street level bureaucrats’ who may profoundly affect the way an intervention is administered.Trial registrationCurrent Controlled Trials ISRCTN50689131, registered 21 April 2009.The trial protocol is available at the following web address: http://www.hst.org.za/publications/study-protocol-economic-incentives-improving-clinical-outcomes-patients-tb-south-africa.
Highlights
Poverty undermines the adherence of patients to tuberculosis treatment
TB is the most common cause of death in South Africa [2] and this is due in part to widespread coinfection with Human Immunodeficiency virus (HIV), poverty still plays an important role in the continued significance of the disease [3,4]
This paper reports on the qualitative process evaluation of a cluster randomized controlled trial, in which the effect of economic support on the outcomes of patients with active TB in South Africa was investigated [12]
Summary
Poverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients’ adherence to treatment, and their treatment outcomes. The trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. Poverty increases the risk of infection and disease and, through its effects on nutrition as well as its impact on adherence to treatment, undermines the outcomes of patients on TB treatment. Economic interventions may assist patients to adhere to their TB treatment schedules, very few studies have been conducted to evaluate their effects [10]. Most of the trials that have investigated this took place in the United States [11], and may not be generalizable to poor- and middle-income countries where the burden of TB is highest
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