Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial

Trials

Jimmy Volmink²  Simon Lewin¹  Elizabeth Lutge³ 

[1] Health Systems Research Unit, South African Medical Research Council and Norwegian Knowledge Centre for the Health Services, Francie van Zyl Drive, Parrow 7505, South Africa;Cochrane Centre, South African Medical Research Council, Francie van Zyl Drive, Parrow 7505, South Africa;Faculty of Health Sciences, Stellenbosch University, Francie van Zijl Drive, Tygerberg 7505, South Africa

关键词: RCT;    Qualitative process evaluation;    Tuberculosis;    Enablers;    Incentives;    Support;    Economic;   

Others  :  812538
DOI  :  10.1186/1745-6215-15-236

 received in 2014-03-03, accepted in 2014-05-27,  发布年份 2014

【 摘 要 】

Background

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. 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.

Methods

In-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.

Results

The 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.

Conclusions

This 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 registration

Current 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.

【 授权许可】

   
2014 Lutge et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Hargreaves JR, Boccia D, Evans CA, Adato M, Petticrew M, Porter JDH: The social determinants of tuberculosis: from evidence to action. Am J Public Health 2011, 101:654-662.
• [2]Statistics South Africa: Mortality and causes of death in South Africa, 2009: findings from death notifications. Pretoria: Statistics South Africa; 2011.
• [3]Abdool Karim SS, Churchyard GJ, Abdool Karim Q, Lawn SD: HIV infection and tuberculosis in South Africa: an urgent need to escalate the public health response. Lancet 2009, 374:921-933.
• [4]Van Rensburg D, Janse-van Rensburg-Bonthuyzen E, Heunis JC, Meulemans H: Tuberculosis control in South Africa: reasons for persistent failure. In Tuberculosis: Multidisciplinary Approaches to Research, Policy and Practice. Acta Academica Supplementum Volume 1. Edited by van Rensburg D, Meulemans H, Rigouts L. Bloemfontein: University of the Free State-SASOL Library; 2005:1-55.
• [5]Bates I, Fenton C, Gruber J, Lalloo D, Lara AM, Squire SB, Theobald S, Thomson R, Tolhurst R: Vulnerability to malaria, tuberculosis, and HIV/AIDS infection and disease. Part 1: determinants operating at individual and household level. Lancet Infect Dis 2004, 4:267-277.
• [6]Day C, Barron P, Monticelli F, Sello E: The District Health Barometer 2007/08. Durban: Health Systems Trust; 2009.
• [7]Naidoo P, Dick J, Cooper D: Exploring tuberculosis patients’ adherence to treatment regimens and prevention programs at a public health site. Qual Health Res 2009, 19:55-70.
• [8]Yach D: Tuberculosis in the Western Cape health region of South Africa. Soc Sci Med 1988, 7:683-689.
• [9]Rowe KA, Makhubele B, Hargreaves JR, Porter JD, Hausler HP, Pronyk PM: Adherence to TB preventive therapy for HIV-positive patients in rural South Africa: implications for antiretroviral delivery in resource-poor settings? Int J Tuberc Lung Dis 2005, 9:263-269.
• [10]Boccia D, Hargreaves J, Lonnroth K, Jaramillo E, Weiss J, Uplekar M, Porter JDH, Evans CA: Cash transfer and microfinance interventions for tuberculosis control: review of the impact evidence and policy implications. Int J Tuberc Lung Dis 2011, 15(Suppl 2):37-49.
• [11]Lutge EE, Wiysonge CS, Knight SE, Volmink J: Material incentives and enablers in the management of tuberculosis. Cochrane Database Syst Rev 2012, 1:CD007952.
• [12]Lutge E, Lewin S, Volmink J, Friedman I, Lombard C: Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial. Trials 2013, 14:154. BioMed Central Full Text
• [13]Lewin S, Glenton C, Oxman A: Use of qualitative methods alongside randomized controlled trials of complex healthcare interventions: methodological study. BMJ 2009, 339:b3496.
• [14]Oakley A, Strange V, Bonnell C, Allen E, Stephenson J: RIPPLE Study Team: Process evaluation in randomized controlled trials of complex interventions. BMJ 2006, 332:413-416.
• [15]Rychetnik L, Frommer M, Hawe P, Shiell A: Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health 2002, 56:119-127.
• [16]Lund F: Changing Social Policy: The Child Support Grant in South Africa. Cape Town: Human Sciences Research Council; 2008. [http://www.hsrcpress.ac.za/product.php?productid=2213]
• [17]Seekings J: The Carnegie Commission and the Backlash against Wefare State-Building in South Africa, 1931–1937. CSSR Working Paper No. 159. Centre for Social Science Research, University of Cape Town; 2006. [http://www.cssr.uct.ac.za/sites/cssr.uct.ac.za/files/pubs/wp159.pdf]
• [18]Day C, Barron P, Massyn N, Padarath A, English R (Eds): District Health Barometer 2010/11. Durban: Health Systems Trust; 2012.
• [19]Green J, Thorogood N: Qualitative Methods for Health Research. London: Sage Publications; 2004.
• [20]Hanson K, Nathan R, Marchant T, Mponda H, Jones C, Bruce J, Stephen G, Mulligan J, Mshinda H, Schellenberg JA: Vouchers for scaling up insecticide-treated nets in Tanzania: methods for monitoring and evaluation of a national health system intervention. BMC Public Health 2008, 8:205. BioMed Central Full Text
• [21]Walker L, Gilson L: ‘We are bitter but we are satisfied’: nurses as street-level bureaucrats in South Africa. Soc Sci Med 2004, 59:1251-1261.
• [22]Lipsky M: Street-Level Bureaucracy: Dilemmas of the Individual in Public Services. New York: Russell Sage Foundation; 1980.
• [23]Dick J, Murray E, Botha E: The Effectiveness of TB DOTS Supporters in South Africa. Operations Research Results. Bethesda, MD: Published for the U.S. Agency for International Development (USAID) by the Quality Assurance Project (QAP); Available at http://www.hciproject.org/sites/default/files/PNADF972.pdf. Accessed on 9 November 2012
• [24]Adato M, Roopnaraine T, Becker E: Understanding use of health services in conditional cash transfer programs: insights from qualitative research in Latin America and Turkey. Soc Sci Med 2011, 72:1921-1929.
• [25]Case A, Menendez A: Does money empower the elderly? Evidence from the Agincourt demographic surveillance site, South Africa. Scand J Public Health 2007, 69:157-164.
• [26]Rosenzweig M: Programme intervention, intrahousehold distribution and the welfare of individuals: Modeling household behaviour. World Dev 1986, 14:233-243.
• [27]Cegielski JP, Arab L, Cornoni-Huntley J: Nutritional risk factors for tuberculosis among adults in the United States, 1971–1992. Am J Epidemiol 2012, 176:409-422.
• [28]Tverdal A: Body mass index and tuberculosis. Eur J Respir Dis 1986, 69:355-362.
• [29]Edwards LB, Livesay VT, Acquaviva FA, Palmer CE: Height, weight, tuberculosis infection, and tuberculous disease. Arch Environ Health 1971, 22:106-112.
• [30]Hall K: Income and social grants – children living in poverty. The Children’s Institute, University of Cape Town; 2010. [http://childrencount.ci.org.za/uploads/factsheet_14.pdf]
• [31]Humanitarian news and analysis: a service of the UN Office for the Coordination of Humanitarian Affairs (IRIN): South Africa: Social Grants - dependency or development? IRIN, November 2007. [http://www.irinnews.org/report.aspx?reportid=75572]
• [32]Bowlby C: The deserving or undeserving poor. BBC News Magazine; 2010. [http://www.bbc.co.uk/news/magazine-11778284]
• [33]Leibbrandt M, Finn A, Woolard I: Describing and decomposing post-apartheid income inequality in South Africa. Dev South Afr 2012, 29:19-34.
• [34]Coetzee M: Finding the Benefits: Estimating the Impact of the South African Child Support Grant. Stellenbosch Economic Working Papers: 16/11. Department of Economics: University of Stellenbosch; 2011. [http://www.ekon.sun.ac.za/wpapers/2011/wp162011/wp-16-2011.pdf]