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The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial
Univ Warwick, Warwick Med Sch, Div Hlth Sci, Coventry CV4 7AL, W Midlands, England.
Univ Witwatersrand, Sch Publ Hlth, Ctr Hlth Policy, Fac Hlth Sci, ZA-2193 Johannesburg, South Africa.
WHO, CH-1211 Geneva 27, Switzerland.
Univ Witwatersrand, Sch Publ Hlth, Div Epidemiol & Biostat, Fac Hlth Sci, ZA-2193 Johannesburg, South Africa.
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2014 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, 435- p.Article in journal (Refereed) Published
Abstract [en]

Background: South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension.

Methods/Design: The Nkateko trial will test the effectiveness of clinic-based lay health workers (LHWs) in supporting hypertension management. It is a pragmatic, cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa, and it is underpinned by long-term health and demographic surveillance. Eight primary care facilities, with their catchment communities, are randomised to usual care or the addition of LHWs focused on chronic care. All clinics (intervention and control) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records. Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions, particularly hypertension. The LHWs will be supported by an implementation manager, who will work with clinic staff to develop the most effective role for the LHWs. Control clinics will continue to provide usual care. The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease. A process evaluation will be based on a realist approach using patient exit interviews, clinic observations and interviews with health professionals, LHWs and patients to document the intervention and its implementation.

Discussion: There are challenges in the design of this trial. Assessing change through population surveys may reduce measurable effects; however, we feel this is appropriate because we aim to attract those who currently do not use clinics, and we hope to improve care for clinic users. Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community. We are constantly working to achieve an effective balance between the intervention and process evaluations.

Place, publisher, year, edition, pages
2014. Vol. 15, 435- p.
National Category
Public Health, Global Health, Social Medicine and Epidemiology
URN: urn:nbn:se:umu:diva-98866DOI: 10.1186/1745-6215-15-435ISI: 000346096800001OAI: diva2:786468
Available from: 2015-02-05 Created: 2015-01-27 Last updated: 2016-02-26Bibliographically approved

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